(a) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802), except that certain terms used in part 1316 of this chapter are defined at the beginning of each subpart of that part.

(b) As used in parts 1301 through 1308 and part 1312 of this chapter, the following terms shall have the meanings specified:

(1) The term Act means the Controlled Substances Act, as amended (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).

(2) The term Administration means the Drug Enforcement Administration.

(3) The term Administrator means the Administrator of the Drug Enforcement Administration. The Administrator has been delegated authority under the Act by the Attorney General (28 CFR 0.100).

(4) The term anabolic steroid means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, and corticosteroids) that promotes muscle growth, and includes:

(i) Boldenone;

(ii) Chlorotestosterone (4-chlortestosterone);

(iii) Clostebol;

(iv) Dehydrochlormethyltestosterone;

(v) Dihydrotestosterone (4-dihydrotestosterone);

(vi) Drostanolone;

(vii) Ethylestrenol;

(viii) Fluoxymesterone;

(ix) Formebulone (formebolone);

(x) Mesterolone;

(xi) Methandienone;

(xii) Methandranone;

(xiii) Methandriol;

(xiv) Methandrostenolone;

(xv) Methenolone;

(xvi) Methyltestosterone;

(xvii) Mibolerone;

(xviii) Nandrolone;

(xix) Norethandrolone;

(xx) Oxandrolone;

(xxi) Oxymesterone;

(xxii) Oxymetholone;

(xxiii) Stanolone;

(xxiv) Stanozolol;

(xxv) Testolactone;

(xxvi) Testosterone;

(xxvii) Trenbolone; and

(xxviii) Any salt, ester, or isomer of a drug or substance described or listed in this paragraph, if that salt, ester, or isomer promotes muscle growth. Except such term does not include an anabolic steroid which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the Secretary of Health and Human Services for such administration. If any person prescribes, dispenses, or distributes such steroid for human

use, such person shall be considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of this paragraph.

(5) The term basic class means, as to controlled substances listed in Schedules I and II:

(i) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in Sec. 1308.11(b) of this chapter;

(ii) Each of the opium derivatives, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in Sec. 1308.11(c) of this chapter;

(iii) Each of the hallucinogenic substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in Sec. 1308.11(d) of this chapter;

(iv) Each of the following substances, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(A) Opium, including raw opium, opium extracts, opium fluid extracts, powdered opium, granulated opium, deodorized opium and tincture of opium;

(B) Apomorphine;

(C) Codeine;

(D) Etorphine hydrochloride;

(E) Ethylmorphine;

(F) Hydrocodone;

(G) Hydromorphone;

(H) Metopon;

(I) Morphine;

(J) Oxycodone;

(K) Oxymorphone;

(L) Thebaine;

(M) Mixed alkaloids of opium listed in Section 1308.12(b)(2) of this chapter;

(N) Cocaine; and

(O) Ecgonine;

(v) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in Sec. 1308.12(c) of this chapter; and

(vi) Methamphetamine, its salts, isomers, and salts of its isomers;

(vii) Amphetamine, its salts, optical isomers, and salts of its optical isomers;

(viii) Phenmetrazine and its salts;

(ix) Methylphenidate;

(x) Each of the substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in Sec. 1308.12(e) of this chapter.

(6) The term commercial container means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term commercial container does not include any package liner, package insert or other material kept with or within a commercial container, nor any carton, crate, drum, or other package in which commercial containers are stored or are used for shipment of controlled substances.

(7) The term compounder means any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages or changes the dosage form of a narcotic drug listed in Schedules II, III, IV or V for use in maintenance or detoxification treatment by another narcotic treatment program.

(8) The term controlled substance has the meaning given in section 802(6) of Title 21, United States Code (U.S.C.).

(9) The term customs territory of the United States means the several States, the District of Columbia, and Puerto Rico.

(10) The term detoxification treatment means the dispensing, for a period of time as specified below, of a narcotic drug or narcotic drugs in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time.

There are two types of detoxification treatment: Short-term detoxification treatment and long-term detoxification treatment.

(i) Short-term detoxification treatment is for a period not in excess of 30 days.

(ii) Long-term detoxification treatment is for a period more than 30 days but not in excess of 180 days.

(11) The term dispenser means an individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance.

(12) The term export means, with respect to any article, any taking out or removal of such article from the jurisdiction of the United States (whether or not such taking out or removal constitutes an exportation within the meaning of the customs and related laws of the United States).

(13) The term exporter includes every person who exports, or who acts as an export broker for exportation of, controlled substances listed in any schedule.

(14) The term hearing means:

(i) In part 1301 of this chapter, any hearing held for the granting, denial, revocation, or suspension of a registration pursuant to sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).

(ii) In part 1303 of this chapter, any hearing held regarding the determination of aggregate production quota or the issuance, adjustment, suspension, or denial of a procurement quota or an individual manufacturing quota.

(iii) In part 1308 of this chapter, any hearing held for the issuance, amendment, or repeal of any rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).

(15) The term import means, with respect to any article, any bringing in or introduction of such article into either the jurisdiction of the United States or the customs territory of the United States, and from the jurisdiction of the United States into the customs territory of the United States (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States).

(16) The term importer includes every person who imports, or who acts as an import broker for importation of, controlled substances listed in any schedule.

(17) The term individual practitioner means a physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, or an institutional practitioner.

(18) The term institutional practitioner means a hospital or other person (other than an individual) licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.

(19) The term interested person means any person adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).

(20) The term inventory means all factory and branch stocks in finished form of a basic class of controlled substance manufactured or otherwise acquired by a registrant, whether in bulk, commercial containers, or contained in pharmaceutical preparations in the possession of the registrant (including stocks held by the registrant under separate registration as a manufacturer, importer, exporter, or distributor).

(21) The term isomer means the optical isomer, except as used in Sec. 1308.11(d) and Sec. 1308.12(b)(4) of this chapter. As used in Sec. 1308.11(d) of this chapter, the term isomer means the optical, positional, or geometric isomer. As used in Sec. 1308.12(b)(4) of this chapter, the term isomer means the optical or geometric isomer.

(22) The term jurisdiction of the United States means the customs territory of the United States, the Virgin Islands, the Canal Zone, Guam, American Samoa, and the Trust Territories of the Pacific Islands.

(23) The term label means any display of written, printed, or graphic matter placed upon the commercial container of any controlled substance by any manufacturer of such substance.

(24) The term labeling means all labels and other written, printed, or graphic matter:

(i) Upon any controlled substance or any of its commercial containers or wrappers, or

(ii) Accompanying such controlled substance.

(25) The term Long Term Care Facility (LTCF) means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients.

(26) The term maintenance treatment means the dispensing for a period in excess of twenty-one days, of a narcotic drug or narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug.

(27) The term manufacture means the producing, preparation, propagation, compounding, or processing of a drug or other substance or the packaging or repackaging of such substance, or the labeling or relabeling of the commercial container of such substance, but does not include the activities of a practitioner who, as an incident to his/her administration or dispensing such substance in the course of his/her professional practice, prepares, compounds, packages or labels such substance. The term manufacturer means a person who manufactures a drug or other substance, whether under a registration as a manufacturer or under authority of registration as a researcher or chemical analyst.

(28) The term mid-level practitioner means an individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice.

Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the state in which they practice.

(29) The term name means the official name, common or usual name, chemical name, or brand name of a substance.

(30) The term narcotic drug means any of the following whether produced directly or indirectly by extraction from substances of vegetable origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis:

(i) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium.

(ii) Poppy straw and concentrate of poppy straw.

(iii) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine and derivatives of ecgonine or their salts have been removed.

(iv) Cocaine, its salts, optical and geometric isomers, and salts of isomers.

(v) Ecgonine, its derivatives, their salts, isomers and salts of isomers.

(vi) Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in paragraphs (b)(31)(i) through (v) of this section.

(31) The term narcotic treatment program means a program engaged in maintenance and/or detoxification treatment with narcotic drugs.

(32) The term net disposal means, for a stated period, the quantity of a basic class of controlled substance distributed by the registrant to another person, plus the quantity of that basic class used by the registrant in the production of (or converted by the registrant into) another basic class of controlled substance or a noncontrolled substance, plus the quantity of that basic class otherwise disposed of by the registrant, less the quantity of that basic class returned to the registrant by any purchaser, and less the quantity of that basic class distributed by the registrant to another registered manufacturer of that basic class for purposes other than use in the production of, or conversion into, another basic class of controlled substance or a noncontrolled substance or in the manufacture of dosage forms of that basic class.

(33) The term pharmacist means any pharmacist licensed by a State to dispense controlled substances, and shall include any other person (e.g., pharmacist intern) authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.

(34) The term person includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.

(35) The term prescription means an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user. (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.)

(36) The term proceeding means all actions taken for the issuance, amendment, or repeal of any rule issued pursuant to section 201 of the Act (21 U.S.C. 811), commencing with the publication by the Administrator of the proposed rule, amended rule, or repeal in the Federal Register.

(37) The term purchaser means any registered person entitled to obtain and execute order forms pursuant to Section 1305.04 and Section 1305.06.

(38) The term readily retrievable means that certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be

separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.

(39) The terms register and registration refer only to registration required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 or 957).

(40) The term registrant means any person who is registered pursuant to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).

(41) The term supplier means any registered person entitled to fill order forms pursuant to Sec. 1305.08 of this chapter.

General Information

Sec.

1301.01 Scope of Part 1301.

1301.02 Definitions.

1301.03 Information; special instructions.

Requirements for Registration

1301.21 Persons required to register.

1301.22 Separate registration for independent activities.

1301.23 Separate registrations for separate locations.

1301.24 Exemption of agents and employees; affiliated practitioners.

1301.25 Exemption of certain military and other personnel.

Sec. 1301.01 Scope of Part 1301.

Procedures governing the registration of manufacturers, distributors, and dispensers of controlled substances pursuant to sections 1301 through 1304 of the Act (21 U.S.C. 821-824) are set forth generally by those sections and specifically by the sections of this part.

Sec. 1301.02 Definitions.

As used in this part, the following terms shall have the meanings specified:

(a) The term Act means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

(b) The term basic class means, as to controlled substances listed in Schedules I and II:

(1) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in Sec. 1308.11 (b) of this chapter;

(2) Each of the opium derivatives, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in Sec. 1308.11(c) of this chapter;

(3) Each of the hallucinogenic substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in Sec. 1308.11(d) of this chapter;

(4) Each of the following substances, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(i) Opium, including raw opium, opium extracts, opium fluid extracts, powdered opium, granulated opium, deodorized opium and tincture of opium;

(ii) Apomorphine;

(iii) Codeine;

(iv) Etorphine hydrochloride;

(v) Ethylmorphine;

(vi) Hydrocodone;

(vii) Hydromorphone;

(viii) Metopon;

(ix) Morphine;

(x) Oxycodone;

(xi) Oxymorphone;

(xii) Thebaine;

(xiii) Mixed alkaloids of opium listed in Sec. 1308.12(b) (2) of this chapter;

(xiv) Cocaine; and

(xv) Ecgonine;

(5) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in Sec. 1308.12 (c) of this chapter; and

(6) Methamphetamine, its salts, isomers, and salts of its isomers;

(7) Amphetamine, its salts, optical isomers, and salts of its optical isomers;

(8) Phenmetrazine and its salts;

(9) Methylphenidate;

(10) Each of the substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in Sec. 1308.12 (e) of this chapter.

(c) The term Administration means the Drug Enforcement Administration.

(d) The term compounder means any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages or changes the dosage form of a narcotic drug listed in Schedules II, III, IV or V for use in maintenance or detoxification treatment by another narcotic treatment program.

(e) The term detoxification treatment means the dispensing, for a period of time as specified below, of a narcotic drug or narcotic drugs in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time. There are two types of detoxification treatment: Short-term detoxification treatment and long-term detoxification treatment.

(1) Short-term detoxification treatment is for a period not in excess of 30 days.

(2) Long-term detoxification treatment is for a period more than 30 days but not in excess of 180 days.

(f) The term Administrator means the Administrator of the Drug Enforcement Administration. The Administrator has been delegated authority under the Act by the Attorney General (28 CFR 0.100).

(g) The term hearing means any hearing held pursuant to this part for the granting, denial, revocation, or suspension of a registration pursuant to sections 303 and 304 of the Act (21 U.S.C. 823-824).

(h) The term maintenance treatment means the dispensing for a period in excess of twenty-one days, of a narcotic drug or narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug.

(i) The term narcotic treatment program means a program engaged in maintenance and/or detoxification treatment with narcotic drugs.

(j) The term person includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.

(k) The terms register and registration refer only to registration required and permitted by section 303 of the Act (21 U.S.C. 823).

(l) The term registrant means any person who is registered pursuant to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).

(m) Any term not defined in this section shall have the definition set forth in section 102 of the Act (21 U.S.C. 802).

Sec. 1301.03 Information; special instructions.

Information regarding procedures under these rules and instructions supplementing these rules will be furnished upon request by writing to the Registration Unit, Drug Enforcement Administration, Department of Justice, Post Office Box 28083, Central Station, Washington, DC 20005.

Requirements for Registration

Sec. 1301.21 Persons required to register.

Every person who manufactures, distributes, or dispenses any controlled substance or who proposes to engage in the manufacture, distribution, or dispensing of any controlled substance shall obtain annually a registration unless exempted by law or pursuant to Secs. 1301.24-1301.29. Only persons actually engaged in such activities are required to obtain a registration; related or affiliated persons who are not engaged in such activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration.)

Sec. 1301.22 Separate registration for independent activities.

(a) The following groups of activities are deemed to be independent of each other:

(1) Manufacturing controlled substances;

(2) Distributing controlled substances;

(3) Dispensing controlled substances listed in Schedules II through V;

(4) Conducting research with controlled substances listed in Schedules II through V;

(5) Conducting instructional activities with controlled substances

listed in schedules II through V;

(6) Conducting a narcotic treatment program using any narcotic drug listed in Schedules II, III, IV or V, however, pursuant to Sec. 1301.24, employees, agents, or affiliated practitioners, in programs, need not register separately. Each program site located away from the principal location and at which place narcotic drugs are stored or dispensed must be separately registered and obtain narcotic drugs by use of order forms pursuant to Sec. 1305.03;

(7) Conducting research and instructional activities with controlled substances listed in Schedule I;

(8) Conducting chemical analysis with controlled substances listed in any schedule;

(9) Importing controlled substances;

(10) Exporting controlled substances; and

(11) A compounder as defined by Sec. 1301.02(d).

(b) Every person who engages in more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided in this paragraph. Any person, when registered to engage in the group of activities described in each subparagraph in this paragraph, shall be authorized to engage in the coincident activities described in that subparagraph without obtaining a registration to engage in such coincident activities, provided that, unless specifically exempted, he complies with all requirements and duties prescribed by law for persons registered to engage in such coincident activities:

(1) A person registered to manufacture or import any controlled substance or basic class of controlled substance shall be authorized to distribute that substance or class, but no other substance or class which he is not registered to manufacture or import;

(2) A person registered to manufacture any controlled substance listed in Schedules II through V shall be authorized to conduct chemical analysis and preclinical research (including quality control analysis) with narcotic and non-narcotic controlled substances listed in those schedules in which he is authorized to manufacture;

(3) A person registered to conduct research with a basic class of controlled substance listed in Schedule I shall be authorized to manufacture or import such class if and to the extent that such manufacture or importation is set forth in the research protocol described in Sec. 1301.33 and to distribute such class to other persons registered or authorized to conduct research with such class or registered or authorized to conduct chemical analysis with controlled substances;

(4) A person registered or authorized to conduct chemical analysis

with controlled substances shall be authorized to manufacture and import such substances for analytical or instructional purposes, to distribute such substances to other persons registered or authorized to conduct chemical analysis or instructional activities or research with such substances and to persons exempted from registration pursuant to Sec. 1301.26, to export such substances to persons in other countries performing chemical analysis or enforcing laws relating to controlled substances or drugs in those countries, and to conduct instructional activities with controlled substances; and

(5) A person registered or authorized to conduct research with controlled substances listed in Schedules II through V shall be authorized to conduct chemical analysis with controlled substances listed in those schedules in which he is authorized to conduct research, to manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration, to import such substances for research purposes, to distribute such substances to other persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to Sec. 1301.26, and to conduct instructional activities with controlled substances;

(6) A person registered to dispense controlled substances in Schedules II through V shall be authorized to conduct research and to conduct instructional activities with those substances, except that a mid-level practitioner, as defined in Sec. 1304.02(f), may conduct research coincident to his/her practitioner registration only to the extent expressly authorized by state statute.

(c) A single registration to engage in any group of independent activities may include one or more controlled substances listed in the schedules authorized in that group of independent activities. A person registered to conduct research with controlled substances listed in Schedule I may conduct research with any substance listed in Schedule I for which he has filed and had approved a research protocol.

Sec. 1301.23 Separate registrations for separate locations.

(a) A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, or dispensed by a person.

(b) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed:

(1) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations other than the registered location from which the substances were delivered or to persons not required to register by virtue of subsection 302(c)(2) of the Act (21 U.S.C. 822(c)(2));

(2) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a distribution point for filling sales orders; and

(3) An office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.

Sec. 1301.24 Exemption of agents and employees; affiliated practitioners.

(a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his business or employment.

(b) An individual practitioner, as defined in section 1304.02 of this chapter, who is an agent or employee of another individual practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the normal course of business or employment, administer or dispense (other than by issuance of prescription) controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered him/herself.

(c) An individual practitioner, as defined in Sec. 1304.02 of this chapter, who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution which is registered in lieu of being registered him/herself, provided that:

(1) Such dispensing, administering or prescribing is done in the usual course of his professional practice;

(2) Such individual practitioner is authorized or permitted to do so by the jurisdiction in which he is practicing;

(3) The hospital or other institution by whom he is employed has verified that the individual practitioner is so permitted to dispense, administer, or prescribe drugs within the jurisdiction;

(4) Such individual practitioner is acting only within the scope of his employment in the hospital or institution;

(5) The hospital or other institution authorizes the individual practitioner to administer, dispense or prescribe under the hospital registration and designates a specific internal code number for each individual practitioner so authorized. The code number shall consist of numbers, letters, or a combination thereof and shall be a suffix to the institution's DEA registration number, preceded by a hyphen (e.g., AP0123456-10 or AP0123456-A12); and

(6) A current list of internal codes and the corresponding individual practitioners is kept by the hospital or other institution and is made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner.

Sec. 1301.25 Exemption of certain military and other personnel.

(a) The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer, but not to procure or purchase, controlled substances in the course of his official duties. Such officials shall follow procedures set forth in part 1306 of this chapter regarding

prescriptions, but shall state the branch of service or agency (e.g., ``U.S. Army'' or ``Public Health Service'') and the service identification number of the issuing official in lieu of the registration number required on prescription forms. The service identification number for a Public Health Service employee is his Social Security identification number.

(b) If any official exempted by this section also engages as a private individual in any activity or group of activities for which registration is required, such official shall obtain a registration for such private activities.

Sec.

1302.01 Scope of Part 1302.

1302.02 Definitions.

1302.03 Symbol required; exceptions.

1302.04 Location and size of symbol on label.

1302.05 Location and size of symbol on labeling.

1302.06 Effective dates of labeling requirements.

Sec. 1302.01 Scope of Part 1302.

Requirements governing the labeling and packaging of controlled substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 825 and 958(d)) are set forth generally by those sections and specifically by the sections of this part.

Sec. 1302.02 Definitions.

As used in this part, the following terms shall have the meanings specified:

(a) The term commercial container means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term commercial container does not include any package liner, package insert or other material kept with or within a commercial container, nor any carton, crate, drum, or other package in which commercial containers are stored or are used for shipment of controlled substances.

(b) The term label means any display of written, printed, or graphic matter placed upon the commercial container of any controlled substance by any manufacturer of such substance.

(c) The term labeling means all labels and other written, printed, or graphic matter (1) upon any controlled substance or any of its commercial containers or wrappers, or (2) accompanying such controlled substance.

(d) The term manufacture means the producing, preparation, propagation, compounding, or processing of a drug or other substance or the packaging or repackaging of such substance, or the labeling or relabeling of the commercial container of such substance, but does not include the activities of a practitioner who, as an incident to his administration or dispensing such substance in the course of his professional practice, prepares, compounds, packages or labels such substance. The term manufacturer means a person who manufactures a drug or other substance, whether under a registration as a manufacturer or under authority of registration as a researcher or chemical analyst.

(e) Any term not defined in this section shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or Sec. 1301.02 of this chapter.

Sec. 1302.03 Symbol required; exceptions.

(a) Each commercial container of a controlled substance (except for a controlled substance excepted by the Administrator pursuant to Sec. 1308.31 of this chapter) shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial container, if it otherwise has no label, must bear a label complying with the requirement of this part.

(b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him the symbol designating the schedule in which such controlled substance is listed.

(c) The following symbols shall designate the schedule corresponding

thereto:

Schedule

Schedule I................................ CI or C-I.

Schedule II............................... CII or C-II.

Schedule III.............................. CIII or C-III.

Schedule IV............................... CIV or C-IV.

Schedule V................................ CV or C-V.

The word ``schedule'' need not be used. No distinction need be made between narcotic and nonnarcotic substances.

(d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through such carton or wrapper.

(e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user.

(f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind and double blind studies.

Sec. 1302.04 Location and size of symbol on label.

(a) The symbol shall be prominently located on the right upper corner of the principal panel of the label of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance listed in Schedules I through V. The symbol must be at least two times as large as the largest type otherwise printed on the label.

(b) In lieu of locating the symbol in the corner of the label, as prescribed in paragraph (a) of this section, the symbol may be overprinted on the label, in which case the symbol must be printed at least one-half the height of the label and in a contrasting color providing clear visibility against the background color of the label.

(c) In all cases the symbol shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf.

Sec. 1302.05 Location and size of symbol on labeling.

The symbol shall be prominently located on all labeling other than labels covered by Sec. 1302.04. In all cases the symbol shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling.

Sec. 1302.06 Effective dates of labeling requirements.

(a) All labels on commercial containers of, and all labeling of, a controlled substance which is listed in any schedule on May 1, 1971, and which is packaged after December 1, 1971, shall comply with the requirements of Sec. 1302.03.

(b) All labels on commercial containers of, and all labeling of, a controlled substance which either is listed in any schedule on May 1, 1971, and thereafter transferred to another schedule or is added to any schedule after May 1, 1971, and which is packaged more than 180 days following the date on which the transfer or addition becomes effective, shall comply with the requirements of Sec. 1302.03.

(c) The Administrator may, in the case of any controlled substance, require compliance with the requirements of Sec. 1302.03 within a period of time shorter than required by this section if he finds that public health or safety necessitate an earlier effective date.

(d) Until compliance is required under this section, the label on commercial container containing, and the labeling of, any controlled substance shall comply with any requirements under Federal law as to labels of such containers and as to labeling of such substances existing prior to the effective date prescribed in this section.

General Information

Sec.

1304.01 Scope of Part 1304.

1304.02 Definitions.

1304.03 Persons required to keep records and file reports.

1304.04 Maintenance of records and inventories.

Inventory Requirements

1304.11 General requirements for inventories.

1304.12 Initial inventory date.

1304.13 Biennial inventory date.

1304.14 Inventory date for newly controlled substances.

1304.17 Inventories of dispensers and researchers.

Continuing Records

1304.21 General requirements for continuing records.

General Information

Sec. 1304.01 Scope of Part 1304.

Inventory and other records and reports required under section 307 or section 1008(d) of the Act (21 U.S.C. 827 and 958(d)) shall be in accordance with, and contain the information required by, those sections and by the sections of this part.

Sec. 1304.02 Definitions.

As used in this part, the following terms shall have the meanings specified:

(a) The term Act means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

(b) The term commercial container means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term commercial container does not include any package liner, package insert of other material kept with or within a commercial container, nor any carton, crate, drum, or other package in which commercial containers are stored or are used for shipment of controlled substances.

(c) The term dispenser means an individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance.

(d) The term individual practitioner means a physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, or an institutional practitioner.

(e) The term institutional practitioner means a hospital or other person (other than an individual) licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.

(f) The term mid-level practitioner means an individual practitioner (as defined in Sec. 1304.02(d)), other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the state in which they practice.

(g) The term name means the official name, common or usual name, chemical name, or brand name of a substance.

(h) The term pharmacist means any pharmacist licensed by a State to dispense controlled substances, and shall include any other person (e.g., pharmacist intern) authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.

(i) The term readily retrievable means that certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on

which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.

(j) Any term not defined in this section shall have the definition set forth in sections 102 and 1001 of the Act (21 U.S.C. 802 and 951) and in Secs. 1301.02 and 1311.02 of this chapter.

Sec. 1304.03 Persons required to keep records and file reports.

(a) Each registrant shall maintain the records and inventories and shall file the reports required by this part, except as exempted by this section. Any registrant who is authorized to conduct other activities without being registered to conduct those activities, either pursuant to Sec. 1301.22(b) of this chapter or pursuant to Secs. 1307.11-1307.15 of this chapter, shall maintain the records and inventories and shall file the reports required by this part for persons registered to conduct such activities. This latter requirement should not be

construed as requiring stocks of controlled substances being used in various activities under one registration to be stored separately, nor that separate records are required for each activity. The intent of the Administration is to permit the registrant to keep one set of records which are adapted by the registrant to account for controlled substances used in any activity. Also, the Administration does not wish to acquire separate stocks of the same substance to be purchased and stored for separate activities. Otherwise, there is no advantage gained by permitting several activities under one registration. Thus, when a researcher manufactures a controlled item, he must keep a record of the quantity manufactured; when he distributes a quantity of the item, he must use and keep invoices or order forms to document the transfer; when he imports a substance, he keeps as part of his records the documentation required of an importer; and when substances are used in chemical analysis, he need not keep a record of this because such a record would not be required of him under a registration to do chemical analysis. All of these records may be maintained in one consolidated record system. Similarly, the researcher may store all of his controlled items in one place, and every two years take inventory of all items on hand, regardless of whether the substances were manufactured by him, imported by him, or purchased domestically by him, of whether the substances will be administered to subjects, distributed to other researchers, or destroyed during chemical analysis.

(b) A registered individual practitioner is required to keep records, as described in Sec. 1304.04, of controlled substances in Schedules II, III, IV, and V which are dispensed, other than by prescribing or administering in the lawful course of professional practice.

(c) A registered individual practitioner is not required to keep records of controlled substances in Schedules II, III, IV, and V which are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment of an individual.

(d) A registered individual practitioner is not required to keep records of controlled substances listed in Schedules II, III, IV and V which are administered in the lawful course of professional practice unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered. Records are required to be kept for controlled substances administered in the course of maintenance or detoxification treatment of an individual.

(e) Each registered mid-level practitioner shall maintain in a readily retrievable manner those documents required by the state in which he/she practices which describe the conditions and extent of his/her authorization to dispense controlled substances and shall make such documents available for inspection and copying by authorized employees of the Administration. Examples of such documentation include protocols, practice guidelines or practice agreements.

(f) A registered person using any controlled substance in research conducted in conformity with an exemption granted under section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i) or 360b(j)) at a registered establishment which maintains records in accordance with either of those sections is not required to keep records if he notifies the Administration of the name, address, and registration number of the establishment maintaining such records.

(g) A registered person using any controlled substance in preclinical research or in teaching at a registered establishment which maintains records with respect to such substances is not required to keep records if he notifies the Administration of the name, address, and registration number of the establishment maintaining such records.

(h) Notice required by paragraphs (f) and (g) of this section shall be given at the time the person applies for registration or reregistration and shall be made in the form of an attachment to the application, which shall be filed with the application.

Sec. 1304.04 Maintenance of records and inventories.

(a) Every inventory and other records required to be kept under this part shall be kept by the registrant and be available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized employees of the Administration, except that financial and shipping records (such as invoices and packing slips but not excuted order forms subject to Sec. 1305.13 of this chapter) may be kept at a central location, rather than at the registered location, if the registrant has notified the Administration of his intention to keep central records. Written notification must be submitted by registered or certified mail, return receipt requested, in triplicate, to the Special Agent in Charge of the Administration in the area in which the registrant is located. Unless the registrant is informed by the Special Agent in Charge that permission to keep central records is denied, the registrant may maintain central records commencing 14 days after receipt of his notification by the Special Agent in Charge.

All notifications must include:

(1) The nature of the records to be kept centrally.

(2) The exact location where the records will be kept.

(3) The name, address, DEA registration number and type of DEA registration of the registrant whose records are being maintained centrally.

(4) Whether central records will be maintained in a manual, or computer readable form.

(b) All registrants that are authorized to maintain a central recordkeeping system shall be subject to the following conditions:

(1) The records to be maintained at the central record location shall not include executed order forms, prescriptions and/or inventories which shall be maintained at each registered location.

(2) If the records are kept on microfilm, computer media or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than pricing information), a key to the code shall be provided to make the records understandable.

(3) The registrant agrees to deliver all or any part of such records to the registered location within two business days upon receipt of a written request from the Administration for such records, and if the Administration chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Administration to inspect such records at the central location upon request by such employees without a warrant of any kind.

(4) In the event that a registrant fails to comply with these conditions, the Special Agent in Charge may cancel such central recordkeeping authorization, and all other central recordkeeping authorizations held by the registrant without a hearing or other procedures. In the event of a cancellation of central recordkeeping

authorizations under this paragraph the registrant shall, within the time specified by the Special Agent in Charge, comply with the requirements of this section that all records be kept at the registered location.

(c) Registrants need not notify the Special Agent in Charge or obtain central recordkeeping approval in order to maintain records on an in-house computer system.

(d) ARCOS participants who desire authorization to report from other than their registered locations must obtain a separate central reporting identifier. Request for central reporting identifiers will be submitted to: ARCOS Unit, P.O. Box 28293, Central Station, Washington, DC 20005.

(e) All central recordkeeping permits previously issued by the Administration expired September 30, 1980.

(f) Each registered manufacturer, distributor, importer, exporter, narcotic treatment program and compounder for narcotic treatment program shall maintain inventories and records of controlled substances as follows:

(1) Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the records of the registrant; and

(2) Inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.

(g) Each registered individual practitioner required to keep records and institutional practitioner shall maintain inventories and records of controlled substances in the manner prescribed in paragraph (f) of this section.

(h) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:

(1) Inventories and records of all controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for such substances shall be maintained in a separate prescription file; and

(2) Inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy, and prescriptions for such substances shall be maintained either in a separate prescription file for controlled substances listed in Schedules III, IV, and V only or in such form that they are readily retrievable from the other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter ``C'' no less than 1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for non-controlled substances. However, if a pharmacy employs an ADP system or other electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red ``C'' is waived.

Sec. 1304.11 Inventory requirements.

(a) General requirements. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. An inventory taken by use of an oral recording device must be promptly transcribed. Controlled substances shall be deemed to be ``on hand'' if they are in the possession of or under the control of the registrant, including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples. A separate inventory shall be made for each registered location and each independent activity registered, except as provided in paragraph (e)(4) of this section. In the event controlled substances in the possession or under the control of the registrant are stored at a location for which he/she is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. The inventory may be taken either as of opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory.

(b) Initial inventory date. Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with paragraph (e) of this section as applicable. In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory.

(c) Biennial inventory date. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.

(d) Inventory date for newly controlled substances. On the effective date of a rule by the Administrator pursuant to Secs. 1308.45, 1308.46, or 1308.47 of this chapter adding a substance to any schedule of controlled substances, which substance was, immediately prior to that date, not listed on any such schedule, every registrant required to keep records who possesses that substance shall take an inventory of all stocks of the substance on hand. Thereafter, such substance shall be included in each inventory made by the registrant pursuant to paragraph (c) of this section.

(e) Inventories of manufacturers, distributors, dispensers, researchers, importers, exporters and chemical analysts. Each person registered or authorized (by Sec. 1301.13 or Secs. 1307.11-1307.13 of this chapter) to manufacture, distribute, dispense, import, export, conduct research or chemical analysis with controlled substances and required to keep records pursuant to Sec. 1304.03 shall include in the inventory the information listed below.

(1) Inventories of manufacturers. Each person registered or authorized to manufacture controlled substances shall include the following information in the inventory:

(i) For each controlled substance in bulk form to be used in (or capable of use in) the manufacture of the same or other controlled or non-controlled substances in finished form, the inventory shall include:

(A) The name of the substance and

(B) The total quantity of the substance to the nearest metric unit weight consistent with unit size.

(ii) For each controlled substance in the process of manufacture on the inventory date, the inventory shall include:

(A) The name of the substance;

(B) The quantity of the substance in each batch and/or stage of

manufacture, identified by the batch number or other appropriate identifying number; and

(C) The physical form which the substance is to take upon completion of the manufacturing process (e.g., granulations, tablets, capsules, or solutions), identified by the batch number or other appropriate identifying number, and if possible the finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number or volume thereof.

(iii) For each controlled substance in finished form the inventory shall include:

(A) The name of the substance;

(B) Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);

(C) The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and

(D) The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials).

(iv) For each controlled substance not included in paragraphs (e)(1) (i), (ii) or (iii) of this section (e.g., damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compoundings) the inventories shall include:

(A) The name of the substance;

(B) The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and

(C) The reason for the substance being maintained by the registrant and whether such substance is capable of use in the manufacture of any controlled substance in finished form.

(2) Inventories of distributors. Each person registered or authorized to distribute controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this section.

(3) Inventories of dispensers and researchers. Each person registered or authorized to dispense or conduct research with controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this section. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows:

(i) If the substance is listed in Schedule I or II, make an exact count or measure of the contents, or

(ii) If the substance is listed in Schedule III, IV or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents.

(4) Inventories of importers and exporters. Each person registered or authorized to import or export controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this section. Each such person who is also registered as a manufacturer or as a distributor shall include in his/her inventory as an importer or exporter only those stocks of controlled substances that are actually separated from his stocks as a manufacturer or as a distributor (e.g., in transit or in storage for shipment).

(5) Inventories of chemical analysts. Each person registered or authorized to conduct chemical analysis with controlled substances shall include in his inventory the same information required of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this section as to substances which have been manufactured, imported, or received by such person. If less than 1 kilogram of any controlled substance (other than a hallucinogenic controlled substance listed in Schedule I), or less than 20 grams of a hallucinogenic substance listed in Schedule I (other than lysergic acid diethylamide), or less than 0.5 gram of lysergic acid diethylamide, is on hand at the time of inventory, that substance need not be included in the inventory.

Laboratories of the Administration may possess up to 150 grams of any hallucinogenic substance in Schedule I without regard to a need for an inventory of those substances. No inventory is required of known or suspected controlled substances received as evidentiary materials for analysis.

Sec. 1304.12 Initial inventory date.

(a) Every person required to keep records who is provisionally registered on May 1, 1971, shall take an inventory of all stocks of controlled substances on hand on that date in accordance with Secs. 1304.15-1304.19, as applicable.

(b) Every person required to keep records who is registered after May 1, 1971, and who was not provisionally registered on that date, shall take an inventory of all stocks of controlled substances on hand on the date he first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with Secs. 1304.15-1304.19, as applicable. In the event a person commences business with no controlled substances on hand, he shall record this fact as his initial inventory.

Sec. 1304.13 Biennial inventory date.

Every 2 years following the date on which the initial inventory is taken by a registrant pursuant to Sec. 1304.12, the registrant shall take a new inventory of all stocks of controlled substances on hand. The biennial inventory may be taken (a) on the day of the year on which the initial inventory was taken or (b) on the registrant's regular general physical inventory date, if any, which is nearest to and does not vary by more than 6 months from the biennial date that would otherwise apply or (c) on any other fixed date which does not vary by more than 6 months from the biennial date that would otherwise apply. If the registrant elects to take the biennial inventory on his regular general physical inventory date or another fixed date, he shall notify the Administration of this election and of the date on which the biennial inventory will be taken.

Sec. 1304.14 Inventory date for newly controlled substances.

On the effective date of a rule by the Administrator pursuant to Secs. 1308.48-1308.49, or Sec. 1308.50 of this chapter adding a substance to any schedule of controlled substances, which substance was, immediately prior to that date, not listed on any such schedule, every registrant required to keep records who possesses that substance shall take an inventory of all stocks of the substance on hand. Thereafter such substance shall be included in each inventory made by the registrant pursuant to Sec. 1304.13.

Sec. 1304.17 Inventories of dispensers and researchers.

Each person registered or authorized (by Sec. 1301.22(b) of this chapter) to dispense or conduct research with controlled substances and required to keep records pursuant to Sec. 1304.03 shall include in his inventory the same information required of manufacturers pursuant to Sec. 1304.15 (c) and (d). In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows:

(a) If the substance is listed in Schedule I or II, he shall make an exact count or measure of the contents; and

(b) If the substance is listed in Schedule III, IV, or V, he shall make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he must make an exact count of the contents.

Sec. 1304.21 General requirements for continuing records.

(a) On and after May 1, 1971, every registrant required to keep records pursuant to Sec. 1304.03 shall maintain on a current basis a complete and accurate record of each such substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him, except that no registrant shall be required to maintain a perpetual inventory.

(b) Separate records shall be maintained by a registrant for each registered location except as provided in Sec. 1304.04 (a). In the event controlled substances are in the possession or under the control of a registrant at a location for which he is not registered, the substances shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.

(c) Separate records shall be maintained by a registrant for each independent activity for which he/she is registered, except as provided in Sec. 1304.22(d).

(d) In recording dates of receipt, importation, distribution, exportation, or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported, or otherwise transferred shall be used as the date of receipt or distribution of any documents of transfer (e.g., invoices or packing slips).

Sec.

1305.01 Scope of Part 1305.

1305.02 Definitions.

1305.03 Distributions requiring order forms.

1305.04 Persons entitled to obtain and execute order forms.

1305.05 Procedure for obtaining order forms.

1305.06 Procedure for executing order forms.

1305.07 Power of attorney.

1305.08 Persons entitled to fill order forms.

1305.09 Procedure for filling order forms.

1305.10 Procedure for endorsing order forms.

1305.11 Unaccepted and defective order forms.

1305.12 Lost and stolen order forms.

1305.13 Preservation of order forms.

1305.14 Return of unused order forms.

1305.15 Cancellation and voiding of order forms.

Sec. 1305.01 Scope of Part 1305.

Procedures governing the issuance, use, and preservation of order forms pursuant to section 1308 of the Act (21 U.S.C. 828) are set forth generally by that section and specifically by the sections of this part.

Sec. 1305.02 Definitions.

As used in this part, the following terms shall have the meanings specified:

(a) The term Act means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

(b) The term purchaser means any registered person entitled to obtain and execute order forms pursuant to Sec. 1305.04 and Sec. 1305.06.

(c) The term supplier means any registered person entitled to fill order forms pursuant to Sec. 1305.08.

(d) Any term not defined in this section shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) and Secs. 1301.02 and 1302.02 of this chapter.

Sec. 1305.03 Distributions requiring order forms.

An order form (DEA Form 222) is required for each distribution of a controlled substance listed in Schedule I or II, except for the following:

(a) The exportation of such substances from the United States in conformity with the Act;

(b) The delivery of such substances to or by a common or contract carrier for carriage in the lawful and usual course of its business, or to or by a warehouseman for storage in the lawful and usual course of its business (but excluding such carriage or storage by the owner of the substance in connection with the distribution to a third person);

(c) The procurement of a sample of such substances by an exempt law enforcement official pursuant to Sec. 1301.26(b) of this chapter, provided that the receipt required by that section is used and is preserved in the manner prescribed in this part for order forms;

(d) The procurement of such substances by a civil defense or disaster relief organization, pursuant to Sec. 1301.27 of this chapter, provided that the Civil Defense Emergency Order Form required by that section is used and is preserved with other records of the registrant; and

(e) The purchase of such substances by the master or first officer of a vessel pursuant to Sec. 1301.28 of this chapter: Provided, That copies of the record of sale are generated, distributed and preserved by the vendor according to that section.

(f) The delivery of such substances to a registered analytical laboratory, or its agent approved by DEA, from an anonymous source for the analysis of the drug sample, provided the laboratory has obtained a written waiver of the order form requirement from the Special Agent in Charge of the Area in which the laboratory is located, which waiver may be granted upon agreement of the laboratory to conduct its activities in accordance with Administration guidelines.

Sec. 1305.04 Persons entitled to obtain and execute order forms.

(a) Order forms may be obtained only by persons who are registered under section 303 of the Act (21 U.S.C. 823) to handle controlled substances listed in Schedules I and II, and by persons who are registered under section 1008 of the Act (21 U.S.C. 958) to export such substances. Persons not registered to handle controlled substances listed in Schedule I or II and persons registered only to import controlled substances listed in any schedule are not entitled to obtain order forms.

(b) An order form may be executed only on behalf of the registrant named thereon and only if his registration as to the substances being purchased has not expired or been revoked or suspended.

Sec. 1305.05 Procedure for obtaining order forms.

(a) Order Forms are issued in mailing envelopes containing either seven or fourteen forms, each form containing an original duplicate and triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit, which is based on the business activity of the registrant, will be imposed on the number of order forms which will be furnished on any requisition unless additional forms are specifically requested and a reasonable need for such additional forms is shown.

(b) Any person applying for a registration which would entitle him to obtain order forms may requisition such forms by so indicating on the application form; order forms will be supplied upon the registration of the applicant. Any person holding a registration entitling him to obtain order forms may requisition such forms for the first time by contacting any Division Office or the Registration Unit of the Administration. Any person already holding order forms may requisition additional forms on DEA Form 222a which is mailed to a registrant approximately 30 days after each shipment of order forms to that registrant or by contacting any Division Office or the Registration Unit of the Administration. All requisition forms (DEA Form 222a) shall be submitted to the Registration Unit, Drug Enforcement Administration, Department of Justice, Post Office Box 28083, Central Station, Washington, DC 20005.

(c) Each requisition shall show the name, address, and registration number of the registrant and the number of books of order forms desired. Each requisition shall be signed and dated by the same person who signed the most recent application for registration or for reregistration, or by any person authorized to obtain and execute order forms by a power of attorney pursuant to Sec. 1305.07.

(d) Order forms will be serially numbered and issued with the name, address and registration number of the registrant, the authorized activity and schedules of the registrant. This information cannot be altered or changed by the registrant; any errors must be corrected by the Registration Unit of the Administration by returning the forms with notification of the error.

Sec. 1305.06 Procedure for executing order forms.

(a) Order forms shall be prepared and executed by the purchaser simultaneously in triplicate by means of interleaved carbon sheets which are part of the DEA Form 222. Order forms shall be prepared by use of a typewriter, pen, or indelible pencil.

(b) Only one item shall be entered on each numbered line. There are ten lines on each order form. If one order form is not sufficient to include all items in an order, additional forms shall be used. Order forms for carfentanil etorphine hydrochloride and diprenorphine shall contain only these substances. The total number of items ordered shall be noted on that form in the space provided.

(c) An item shall consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance; a separate item shall be made for each commercial or bulk container of different finished or bulk form, quantity or substance. For each item the form shall show the name of the article ordered, the finished or bulk form of the article (e.g., 10-milligram tablet, 10-milligram concentration per fluid ounce or milliliter, or U.S.P.), the number of units or volume in each commercial or bulk container (e.g., 100-tablet bottle or 3-milliliter vial) or the quantity or volume of each bulk container (e.g., 10 kilograms), the number of commercial or bulk containers ordered, and the name and quantity per unit of the controlled substance or substances contained in the article if not in pure form. The catalogue number of the article may be included at the discretion of the purchaser.

(d) The name and address of the supplier from whom the controlled substances are being ordered shall be entered on the form. Only one supplier may be listed on any one form.

(e) Each order form shall be signed and dated by a person authorized to sign a requisition for order forms on behalf of the purchaser pursuant to Sec. 1305.05(c). The name of the purchaser, if different from the individual signing the order form, shall also be inserted in the signature space. Unexecuted order forms may be kept and may be executed at a location other than the registered location printed on the form, provided that all unexecuted forms are delivered promptly to the registered location upon an inspection of such location by any officer authorized to make inspections, or to enforce, any Federal, State, or local law regarding controlled substances.

Sec. 1305.07 Power of attorney.

Any purchaser may authorize one or more individuals, whether or not located at the registered location of the purchaser, to obtain and execute order forms on his behalf by executing a power of attorney for each such individual. The power of attorney shall be signed by the same person who signed (or was authorized to sign, pursuant to Sec. 1301.32(f) of this chapter or Sec. 1311.32(f) of this chapter) the most recent application for registration or reregistration and by the individual being authorized to obtain and execute order forms. The power of attorney shall be filed with the executed order forms of the purchaser, and shall be retained for the same period as any order form bearing the signature of the attorney. The power of attorney shall be available for inspection together with other order form records. Any power of attorney may be revoked at any time by executing a notice of revocation, signed by the person who signed (or was authorized to sign) the power of attorney or by a successor, whoever signed the most recent application for registration or reregistration, and filing it with the power of attorney being revoked. The form for the power of attorney and notice of revocation shall be similar to the following:

Power of Attorney for DEA Order Forms

-------------------- (Name of registrant) -------------------- (Address of registrant) -------------------- (DEA registration number) I, ------------------------ (name of person granting power), the undersigned, who is authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act or Controlled Substances Import and Export Act, have made, constituted, and appointed, and by these presents, do make, constitute, and appoint ------------------------ (name of attorney-in-fact), my true and lawful attorney for me in my name, place, and stead, to execute applications for books of official order forms and to sign such order forms in requisition for Schedule I and II controlled substances, in accordance with section 308 of the Controlled Substances Act (21 U.S.C. 828) and part 305 of Title 21 of the Code of Federal Regulations. I hereby ratify and confirm all that said attorney shall lawfully do or cause to be done by virtue hereof.

........................................................................

(Signature of person granting power)

I, ---------------------- (name of attorney-in-fact), hereby affirm that I am the person named herein as attorney-in-fact and that the signature affixed hereto is my signature.

........................................................................

(Signature of attorney-in-fact)

Witnesses:

1. ------------------------.

2. -----------------------.

Signed and dated on the ------ day of ----------------, 19----, at ----------------.

Notice of Revocation

The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act of the Controlled Substances Import and Export Act. Written notice of this revocation has been given to the attorney-in-fact ---------------- this same day.

........................................................................

(Signature of person revoking power)

Witnesses:

1. ------------------------.

2. ------------------------.

Signed and dated on the ------ day of ----------------, 19----, at ----------------.

Sec. 1305.08 Persons entitled to fill order forms.

An order form may be filled only by a person registered as a manufacturer or distributor of controlled substances listed in Schedule I or II under section 303 of the Act (21 U.S.C. 823) or as an importer of such substances under section 1008 of the Act (21 U.S.C. 958), except for the following:

(a) A person registered to dispense such substances under section 303 of the Act, or to export such substances under section 1008 of the Act, if he is discontinuing business or if his registration is expiring without reregistration, may dispose of any controlled substances listed in Schedule I or II in his possession pursuant to order forms in accordance with Sec. 1307.14 of this chapter;

(b) A person who has obtained any controlled substance in Schedule I or II by order form may return such substance, or portion thereof, to the person from whom he obtained the substance or the manufacturer of the substance pursuant to the order form of the latter person;

(c) A person registered to dispense such substances may distribute such substances to another dispenser pursuant to, and only in the circumstances described in, Sec. 1307.11 of this chapter; and

(d) A person registered or authorized to conduct chemical analysis or research with controlled substances may distribute a controlled substance listed in Schedule I or II to another person registered or authorized to conduct chemical analysis, instructional activities, or research with such substances pursuant to the order form of the latter person, if such distribution is for the purpose of furthering such chemical analysis, instructional activities, or research.

(e) A person registered as a compounder of narcotic substances for use at off-site locations in conjunction with a narcotic treatment program at the compounding location, who is authorized to handle Schedule II narcotics, is authorized to fill order forms for distribution of narcotic drugs to off-site narcotic treatment programs only.

Sec. 1305.09 Procedure for filling order forms.

(a) The purchaser shall submit Copy 1 and Copy 2 of the order form to the supplier, and retain Copy 3 in his own files.

(b) The supplier shall fill the order, if possible and if he desires to do so, and record on Copies 1 and 2 the number of commercial or bulk containers furnished on each item and the date on which such containers are shipped to the purchaser. If an order cannot be filled in its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the order form. No order form shall be valid more than 60 days after its execution by the purchaser, except as specified in paragraph (f) of this section.

(c) The controlled substances shall only be shipped to the purchaser and at the location printed by the Administration on the order form, except as specified in paragraph (f) of this section.

(d) The supplier shall retain Copy 1 of the order form for his own files and forward Copy 2 to the Special Agent in Charge of the Drug Enforcement Administration in the area in which the supplier is located. Copy 2 shall be forwarded at the close of the month during which the order is filled; if an order is filled by partial shipments, Copy 2 shall be forwarded at the close of the month during which the final shipment is made or during which the 60-day validity period expires.

(e) The purchaser shall record on Copy 3 of the order form the number of commercial or bulk containers furnished on each item and the dates on which such containers are received by the purchaser.(f) Order forms submitted by registered procurement officers of the Defense Personnel Support Center of Defense Supply Agency for delivery to armed services establishments within the United States may be shipped to locations other than the location printed on the order form, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order.

Sec. 1305.10 Procedure for endorsing order forms.

(a) An order form made out to any supplier who cannot fill all or a part of the order within the time limitation set forth in Sec. 1305.09 may be endorsed to another supplier for filling. The endorsement shall be made only by the supplier to whom the order form was first made, shall state (in the spaces provided on the reverse sides of Copies 1 and 2 of the order form) the name and address of the second supplier, and shall be signed by a person authorized to obtain and execute order forms on behalf of the first supplier. The first supplier may not fill any part

of an order on an endorsed form. The second supplier shall fill the order, if possible and if he desires to do so, in accordance with Sec. 1305.09 (b), (c), and (d), including shipping all substances directly to the purchaser.

(b) Distributions made on endorsed order forms shall be reported by the second supplier in the same manner as all other distributions except that where the name of the supplier is requested on the reporting form, the second supplier shall record the name, address and registration number of the first supplier.

Sec. 1305.11 Unaccepted and defective order forms.

(a) No order form shall be filled if it:

(1) Is not complete, legible, or properly prepared, executed, or endorsed; or

(2) Shows any alteration, erasure, or change of any description.

(b) If an order form cannot be filled for any reason under this section, the supplier shall return Copies 1 and 2 to the purchaser with a statement as to the reason (e.g., illegible or altered). A supplier may for any reason refuse to accept any order and if a supplier refuses to accept the order, a statement that the order is not accepted shall be sufficient for purposes of this paragraph.

(c) When received by the purchaser, Copies 1 and 2 of the order form and the statement shall be attached to Copy 3 and retained in the files of the purchaser in accordance with Sec. 1305.13. A defective order form may not be corrected; it must be replaced by a new order form in order for the order to be filled.

Sec. 1305.12 Lost and stolen order forms.

(a) If a purchaser ascertains that an unfilled order form has been lost, he shall execute another in triplicate and a statement containing the serial number and date of the lost form, and stating that the goods covered by the first order form were not received through loss of that order form. Copy 3 of the second form and a copy of the statement shall be retained with Copy 3 of the order form first executed. A copy of the statement shall be attached to Copies 1 and 2 of the second order form sent to the supplier. If the first order form is subsequently received by the supplier to whom it was directed, the supplier shall mark upon the face thereof ``Not accepted'' and return Copies 1 and 2 to the purchaser, who shall attach it to Copy 3 and the statement.

(b) Whenever any used or unused order forms are stolen or lost (otherwise than in the course of transmission) by any purchaser or supplier, he/she shall immediately upon discovery of such theft or loss, report the same to the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located, stating the serial number of each form stolen or lost. If the theft or loss includes any original order forms received from purchasers and the supplier is unable to state the serial numbers of such order forms, he/she shall report the date or approximate date of receipt thereof and the names and addresses of the purchasers. If an entire book of order forms is lost or stolen, and the purchaser is unable to state the serial numbers of the order forms contained therein, he/she shall report, in lieu of the numbers of the forms contained in such book, the date or approximate date of issuance thereof. If any unused order form reported stolen or lost is subsequently recovered or found, the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located shall immediately be notified.

7. In addition to the amendments set forth above, DEA is amending

each section indicated in the left column by removing the words indicated in the middle column and adding the words in the right

column:

Sec. 1305.13 Preservation of order forms.

(a) The purchaser shall retain Copy 3 of each order form which has been filled. He shall also retain in his files all copies of each unaccepted or defective order form and each statement attached thereto.

(b) The supplier shall retain Copy 1 of each order form which he has filled.

(c) Order forms must be maintained separately from all other records of the registrant. Order forms are required to be kept available for inspection for a period of 2 years. If a purchaser has several registered locations, he must retain Copy 3 of the executed order forms and any attached statements or other related documents (not including unexecuted order forms which may be kept elsewhere pursuant to Sec. 1305.06(e)) at the registered location printed on the order form.

(d) The supplier of carfentanil etorphine hydrochloride and diprenorphine shall maintain order forms for these substances separately from all other order forms and records required to be maintained by the registrant.

Sec. 1305.14 Return of unused order forms.

If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes his name or address as shown on his registration) or is suspended or revoked pursuant to Secs. 1301.45 or 1301.46 of this chapter as to all controlled substances listed in Schedules I and II for which he is registered, he shall return all unused order forms for such substance to the nearest office of the Administration.

Sec. 1305.15 Cancellation and voiding of order forms.

(a) A purchaser may cancel part or all of an order on an order form by notifying the supplier in writing of such cancellation. The supplier shall indicate the cancellation on Copies 1 and 2 of the order form by drawing a line through the canceled items and printing ``canceled'' in the space provided for number of items shipped.

(b) A supplier may void part or all of an order on an order form by notifying the purchaser in writing of such voiding. The supplier shall indicate the voiding in the manner prescribed for cancellation in paragraph (a) of this section.

(c) No cancellation or voiding permitted by this section shall affect in any way contract rights of either the purchaser or the supplier.

General Information

Sec.

1306.01 Scope of Part 1306.

1306.02 Definitions.

1306.03 Persons entitled to issue prescriptions.

1306.04 Purpose of issue of prescription.

1306.05 Manner of issuance of prescriptions.

1306.06 Persons entitled to fill prescriptions.

1306.11 Requirement of prescription.

1306.12 Refilling prescriptions.

1306.13 Partial filling of prescriptions.

1306.14 Labeling of substances.

1306.21 Requirement of prescription.

1306.22 Refilling of prescriptions.

1306.23 Partial filling of prescriptions.

1306.24 Labeling of substances.

1306.25 Filing prescriptions.

1306.26 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.

Sec. 1306.26 Dispensing without prescription.

General Information

Sec. 1306.01 Scope of Part 1306.

Rules governing the issuance, filling and filing of prescriptions

pursuant to section 309 of the Act (21 U.S.C. 829) are set forth

generally in that section and specifically by the sections of this part.

Sec. 1306.02 Definitions.

As used in this part, the following terms shall have the meanings specified:

(a) The term Act means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801).

(b) The term individual practitioner means a physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, or an institutional practitioner.

(c) The term institutional practitioner means a hospital or other person (other than an individual) licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.

(d) The term pharmacist means any pharmacist licensed by a State to dispense controlled substances, and shall include any other person (e.g., a pharmacist intern) authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.

(e) A Long Term Care Facility (LTCF) means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients.

(f) The term prescription means an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate used. (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.)

(g) The terms register and registered refer to registration required and permitted by section 303 of the Act (21 U.S.C. 823).

(h) The term home infusion pharmacy means a pharmacy which compounds solutions for direct administration to a patient in a private residence, Long Term Care Facility or hospice setting by means of parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion.

(i) Any term not defined in this section shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or Sec. 1301.02 of this chapter.

Sec. 1306.03 Persons entitled to issue prescriptions.

(a) A prescription for a controlled substance may be issued only by an individual practitioner who is:

(1) authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and

(2) either registered or exempted from registration pursuant to Secs. 1301.24(c) and 1301.25 of this chapter.

(b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner.

Sec. 1306.04 Purpose of issue of prescription.

(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

(c) A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule for ``detoxification treatment'' or ``maintenance treatment'' as defined in Section 102 of the Act (21 U.S.C. 802).

Sec. 1306.05 Manner of issuance of prescriptions.

(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address and registration number of the practitioner. A practitioner may sign a prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter and shall be manually signed by the practitioner. The prescriptions may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by these regulations.

(b) An individual practitioner exempted from registration under Sec. 1301.24(c) of this chapter shall include on all prescriptions issued by him or her the registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution as provided in Sec. 1301.24(c) of this chapter, in lieu of the registration number of the practitioner required by this section. Each written prescription shall have the name of the physician stamped, typed, or handprinted on it, as well as the signature of the physician.

(c) An official exempted from registration under Sec. 1301.25 shall include on all prescriptions issued by him his branch of service or agency (e.g., ``U.S. Army'' or ``Public Health Service'') and his service identification number, in lieu of the registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his Social Security identification number. Each prescription shall have the name of the officer stamped, typed, or handprinted on it, as well as the signature of the officer.

Sec. 1306.06 Persons entitled to fill prescriptions.

A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy or registered institutional practitioner.

Sec. 1306.07 Administering or dispensing of narcotic drugs.

(a) The administering or dispensing directly (but not prescribing) of narcotic drugs listed in any schedule to a narcotic drug dependent person for ``detoxification treatment'' or ``maintenance treatment'' as defined in section 102 of the Act (21 U.S.C. 802) shall be deemed to be within the meaning of the term ``in the course of his professional practice or research'' in section 308(e) and section 102(20) of the Act (21 U.S.C. 828 (e)): Provided, That the practitioner is separately registered with the Attorney General as required by section 303(g) of the Act (21 U.S.C. 823(g)) and then thereafter complies with the regulatory standards imposed relative to treatment qualification, security, records and unsupervised use of drugs pursuant to such Act.

(b) Nothing in this section shall prohibit a physician who is not specifically registered to conduct a narcotic treatment program from administering (but not prescribing) narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. Not more than one day's medication may be administered to the person or for the person's use at one time. Such emergency treatment may be carried out for not more than three days and may not be renewed or extended.

(c) This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.

Sec. 1306.11 Requirement of prescription.

(a) A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with Sec. 1304.04(h) of this chapter.

(b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule II in the course of his professional practice without a prescription, subject to Sec. 1306.07.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.

(d) In the case of an emergency situation, as defined by the Secretary in Sec. 290.10 of this title, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that:

(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner);

(2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in Sec. 1306.05, except for the signature of the prescribing individual practitioner;

(3) If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and

(4) Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of Sec. 1306.05, the prescription shall have written on its face ``Authorization for Emergency Dispensing,'' and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7 day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

(e) A prescription prepared in accordance with Sec. 1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (e) and it shall be maintained in accordance with Sec. 1304.04(h) of this chapter.

(f) A prescription prepared in accordance with Sec. 1306.05 written for Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be maintained in accordance with Sec. 1304.04(h).

(g) A prescription prepared in accordance with Sec. 1306.05 written for a Schedule II narcotic substance for a patient residing in a hospice certified by Medicare under Title XVIII or licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and it shall be maintained in accordance with Sec. 1304.04(h) of this chapter.

Sec. 1306.12 Refilling prescriptions.

The refilling of a prescription for a controlled substance listed in

Schedule II is prohibited.

Sec. 1306.13 Partial filling of prescriptions.

(a) The partial filling of a prescription for a controlled substance listed in Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

(b) A prescription for a Schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record on the prescription whether the patient is ``terminally ill'' or an ``LTCF patient.'' A prescription that is partially filled and does not contain the notation ``terminally ill'' or ``LTCF patient'' shall be deemed to have been filled in violation of the Act. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication.

(c) Information pertaining to current Schedule II prescriptions for patients in a LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit:

(1) Output (display or printout) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, address of the LTCF or address of the hospital or residence of the patient, identification of medication authorized (to include dosage, form, strength and quantity), listing of the partial fillings that have been dispensed under each prescription and the information required in Sec. 1306.13(b).

(2) Immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted.

(3) Retrieval of partially filled Schedule II prescription information is the same as required by Sec. 1306.22(b) (4) and (5) for Schedule III and IV prescription refill information.

Sec. 1306.14 Labeling of substances.

(a) The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law.

(b) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized: Provided, That:

(1) Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time;

(2) The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration;

(3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II; and

(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

Sec. 1306.15 Filing of prescriptions.

All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of Sec. 1304.04(h) of this chapter.

Sec. 1306.21 Requirement of prescription.

(a) A pharmacist may dispense directly a controlled substance listed in Schedule III or IV, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, only pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner's agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Sec. 1306.05, except for the signature of the practitioner.

(b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule III or IV in the course of his professional practice without a prescription, subject to Sec. 1306.07.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedules III or IV only pursuant to written prescription signed by an individual practitioner, or pursuant to a facsimile of a written prescription or order for medication transmitted by the practitioner or the practitioner's agent to the institutional practitioner-pharmacist, or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in Sec. 1306.05 except for the signature of the individual practitioner), or pursuant to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user, subject to Sec. 1306.07.

Sec. 1306.22 Refilling of prescriptions.

(a) No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued and no such prescription authorized to be refilled may be refilled more than five times. Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document. If entered on another document, such as a medication record, the document must be uniformly maintained and readily retrievable. The following information must be retrievable by the prescription number consisting of the name and dosage form of the controlled substance, the date filled or refilled, the quantity dispensed, initials of the dispensing pharmacist for each refill, and the total number of refills for that prescription. If the pharmacist merely initials and dates the back of the prescription it shall be deemed that the full face amount of the prescription has been dispensed. The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met:

(1) The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issue of the original prescription.

(2) The pharmacist obtaining the oral authorization records on the reverse of the original prescription the date, quantity of refill, number of additional refills authorized, and initials the prescription showing who received the authorization from the prescribing practitioner who issued the original prescription.

(3) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.

(4) The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five refill, six-month limitation.

(b) As an alternative to the procedures provided by subsection (a), an automated data processing system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedule III and IV, subject to the following conditions:

(1) Any such proposed computerized system must provide on-line retrieval (via CRT display or hard-copy printout) of original prescription order information for those prescription orders which are currently authorized for refilling. This shall include, but is not limited to, data such as the original prescription number, date of issuance of the original prescription order by the practitioner, full name and address of the patient, name, address, and DEA registration number of the practitioner, and the name, strength, dosage form, quantity of the controlled substance prescribed (and quantity dispensed if different from the quantity prescribed), and the total number of refills authorized by the prescribing practitioner.

(2) Any such proposed computerized system must also provide on-line retrieval (via CRT display or hard-copy printout) of the current refill history for Schedule III or IV controlled substance prescription orders (those authorized for refill during the past six months.) This refill history shall include, but is not limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.

(3) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order for a Schedule III or IV controlled substance is correct must be provided by the individual pharmacist who makes use of such a system. If such a system provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist must verify that the data indicated is correct and then sign this document in the same manner as he would sign a check or legal document (e.g., J. H. Smith, or John H. Smith). This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date. This printout of the day's controlled substance prescription order refill data must be provided to each pharmacy using such a computerized system within 72 hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown. Such a book or file must be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing the appropriately authorized refill.

(4) Any such computerized system shall have the capability of producing a printout of any refill data which the user pharmacy is responsible for maintaining under the Act and its implementing regulations. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both). Such a printout must include name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or identification code of the dispensing pharmacist, and the number of the original prescription order. In any computerized system employed by a user pharmacy the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours, and if a DEA Special Agent or Compliance Investigator requests a copy of such printout from the user pharmacy, it must, if requested to do so by the Agent or Investigator, verify the printout transmittal capability of its system by documentation (e.g., postmark).

(5) In the event that a pharmacy which employs such a computerized system experiences system down-time, the pharmacy must have an auxiliary procedure which will be used for documentation of refills of Schedule III and IV controlled substance prescription orders. This auxiliary procedure must insure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available for use again.

(c) When filing refill information for original prescription orders for Schedule III or IV controlled substances, a pharmacy may use only one of the two systems described in paragraphs (a) or (b) of this section.

Sec. 1306.23 Partial filling of prescriptions.

The partial filling of a prescription for a controlled substance listed in Schedule III or IV is permissible, provided that:

(a) Each partial filling is recorded in the same manner as a refilling,

(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and

(c) No dispensing occurs after 6 months after the date on which the prescription was issued.

Sec. 1306.24 Labeling of substances.

(a) The pharmacist filling a prescription for a controlled substance listed in Schedule III or IV shall affix to the package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if any, contained in such prescription as required by law.

(b) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule III or IV is prescribed for administration to an ultimate user who is institutionalized:

Provided, That:

(1) Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III or IV is dispensed at one time;

(2) The controlled substance listed in Schedule III or IV is not in the possession of the ultimate user prior to administration;

(3) The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III or IV; and

(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

Section 1306.26 is redesignated as Sec. 1306.25 and amended by revising paragraphs (a) and (b) to read as follows:

Sec. 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.(a) The transfer of original prescription information for a controlled substance listed in Schedules III, IV or V for the purpose of refill dispensing is permissible between pharmacies on a one time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization. Transfers are subject to the following requirements:

(1) The transfer is communicated directly between two licensed pharmacists and the transferring pharmacist records the following information:

(i) Write the word ``VOID'' on the face of the invalidated prescription.

(ii) Record on the reverse of the invalidated prescription the name, address and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information.

(iii) Record the date of the transfer and the name of the pharmacist transferring the information.

(b) The pharmacist receiving the transferred prescription information shall reduce to writing the following:

(1) Write the word ``transfer'' on the face of the transferred prescription.

(2) Provide all information required to be on a prescription pursuant to 21 CFR 1306.05 and include:

(i) Date of issuance of original prescription;

(ii) Original number of refills authorized on original prescription;

(iii) Date of original dispensing;

(iv) Number of valid refills remaining and date(s) and locations of previous refill(s);

(v) Pharmacy's name, address, DEA registration number and prescription number from which the prescription information was transferred;

(vi) Name of pharmacist who transferred the prescription.

(vii) Pharmacy's name, address, DEA registration number and prescription number from which the prescription was originally filled;

(3) The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill.

Sec. 1306.26 Dispensing without prescription.

A controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:

(a) Such dispensing is made only by a pharmacist (as defined in part 1300 of this chapter), and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has

fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a nonpharmacist);

(b) Not more than 240 cc. (8 ounces) of any such controlled

substance containing opium, nor more than 120 cc. (4 ounces) of any other such controlled substance nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage

units of any other such controlled substance may be dispensed at retail to the same purchaser in any given 48-hour period;

(c) The purchaser is at least 18 years of age;

(d) The pharmacist requires every purchaser of a controlled substance under this section not known to him to furnish suitable identification (including proof of age where appropriate);

(e) A bound record book for dispensing of controlled substances under this section is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of

controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with the

recordkeeping requirement of Sec. 1304.04 of this chapter); and

(f) A prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State or local law.

Sec.

1307.01 Definitions.

1307.02 Application of State law and other Federal law.

1307.03 Exceptions to regulations.

Special Exceptions for Manufacture and Distribution of Controlled

Substances

1307.11 Distribution by dispenser to another practitioner.

1307.12 Manufacture and distribution of narcotic solutions and

compounds by a pharmacist.

1307.13 Distribution to supplier.

1307.14 Distribution upon discontinuance or transfer of business.

1307.15 Incidental manufacture of controlled substances.

Disposal of Controlled Substances

1307.21 Procedure for disposing of controlled substances.

1307.22 Disposal of controlled substances by the Administration.

Special Exempt Persons

1307.31 Native American Church.

Sec. 1307.01 Definitions.

As used in this part, the following terms shall have the meanings specified:

(a) The term Act means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

(b) Any term not defined in this section shall have the definition set forth in section 102 and 1001 of the Act (21 U.S.C. 802 and 951) and in Sec. 1301.02 of this chapter.

Sec. 1307.02 Application of State law and other Federal law.

Nothing in parts 1301-1308, 1311, 1312, or 1316 of this chapter shall be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under other Federal laws or obligations under international treaties, conventions or protocols, or under the law of the State in which he desires to do such act nor shall compliance with such parts be construed as compliance with other Federal or State laws unless expressly provided in such other laws.

Sec. 1307.03 Exceptions to regulations.

Any person may apply for an exception to the application of any provision of parts 1301-1313, or 1316 of this chapter by filing a written request stating the reasons for such exception. Requests shall be filed with the Administrator, Drug Enforcement Administration, Department of Justice, Washington, D.C. 20537. The Administrator may grant an exception in his discretion, but in no case shall he be required to grant an exception to any person which is not otherwise required by law or the regulations cited in this section.

Sec. 1307.11 Distribution by dispenser to another practitioner.

(a) A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to another practitioner for the purpose of general dispensing by the practitioner to his or its patients: Provided,

That:

(1) The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance;

(2) The distribution is recorded by the distributing practitioner in accordance with Sec. 1304.24(e) of this chapter and by the receiving practitioner in accordance with Sec. 1304.24(c) of this chapter;

(3) If the substance is listed in Schedule I or II, an order form is used as required in part 1305 of this chapter;

(4) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section and Sec. 1301.28 of this chapter during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year.

(b) If, during any calendar year in which the practitioner is registered to dispense, the practitioner has reason to believe that the total number of dosage units of all controlled substances which will be distributed by him pursuant to this section and Sec. 1301.28 of this chapter will exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by him during that calendar year, the practitioner shall obtain a registration to distribute controlled substances.

Sec. 1307.12 Manufacture and distribution of narcotic solutions and compounds by a pharmacist.

As an incident to a distribution under Sec. 1307.11, a pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding 20 percent of the complete solution, compound, or mixture.

Sec. 1307.13 Distribution to supplier.

Any person lawfully in possession of a controlled substance listed in any schedule may distribute (without being registered to distribute) that substance to the person from whom he obtained it or to the manufacturer of the substance, provided that a written record is maintained which indicates the date of the transaction, the name, form and quantity of the substance, the name, address, and registration number, if any, of the person making the distribution, and the name, address, and registration number, if known, of the supplier or manufacturer. In the case of returning a controlled substance listed in Schedule I or II, an order form shall be used in the manner prescribed in part 1305 of this chapter and be maintained as the written record of the transaction. Any person not required to register pursuant to sections 302(c) or 1007(b)(1) of the Act (21 U.S.C. 823(c) or 957(b)(1)) shall be exempt from maintaining the records required by this section.

Sec. 1307.14 Distribution upon discontinuance or transfer of business.

(a) Any registrant desiring to discontinue business activities altogether or with respect to controlled substances (without transferring such business activities to another person) shall return for cancellation his certificate of registration, and any unexecuted order forms in his possession, to the Registration Unit, Drug Enforcement Administration, Department of Justice, Post Office Box 28083, Central Station, Washington, DC 20005. Any controlled substances in his possession may be disposed of in accordance with Sec. 1307.21. (b) Any registrant desiring to discontinue business activities altogether or with respect to controlled substance (by transferring such business activities to another person) shall submit in person or by registered or certified mail, return receipt requested, to the Special Agent in Charge in his area, at least 14 days in advance of the date of the proposed transfer (unless the Special Agent in Charge waives this time limitation in individual instances), the following information:

(1) The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor);

(2) The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee);

(3) Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed);

(4) Whether the registrant-transferor has a quota to manufacture or procure any controlled substance listed in Schedule I or II (if so, the basic class or class of the substance should be indicated); and

(5) The date on which the transfer of controlled substances will occur.

(c) Unless the registrant-transferor is informed by the Regional Administrator, before the date on which the transfer was stated to occur, that the transfer may not occur, the registrant-transferor may distribute (without being registered to distribute) controlled substances in his possession to the registrant-transferee in accordance with the following:

(1) On the date of transfer of the controlled substances, a complete inventory of all controlled substances being transferred shall be taken in accordance with Secs. 1304.11-1304.19 of this chapter. This inventory shall serve as the final inventory of the registrant-transferor and the initial inventory of the registrant-transferee, and a copy of the inventory shall be included in the records of each person. It shall not be necessary to file a copy of the inventory with the Administration unless requested by the Regional Administrator. Transfers of any substances listed in Schedule I or II shall require the use of order forms in accordance with part 1305 of this chapter.

(2) On the date of transfer of the controlled substances, all records required to be kept by the registrant-transferor with reference to the controlled substances being transferred, under part 1304 of this chapter, shall be transferred to the registrant-transferee.

Responsibility for the accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody and maintenance shall be upon the transferee.

(3) In the case of registrants required to make reports pursuant to part 1304 of this chapter, a report marked ``Final'' will be prepared and submitted by the registrant-transferor showing the disposition of all the controlled substances for which a report is required; no additional report will be required from him, if no further transactions involving controlled substances are consummated by him. The initial report of the registrant-transferee shall account for transactions beginning with the day next succeeding the date of discontinuance or transfer of business by the transferor-registrant and the substances transferred to him shall be reported as receipts in his initial report.

Sec. 1307.15 Incidental manufacture of controlled substances.

Any registered manufacturer who, incidentally but necessarily, manufactures a controlled substance as a result of the manufacture of a controlled substance or basic class of controlled substance for which he is registered and has been issued an individual manufacturing quota pursuant to part 1303 of this chapter (if such substance or class is listed in Schedule I or II) shall be exempt from the requirement of registration pursuant to part 1301 of this chapter and, if such incidentally manufactured substance is listed in Schedule I or II, shall be exempt from the requirement of an individual manufacturing quota pursuant to part 1303 of this chapter, if such substances are disposed of in accordance with Sec. 1307.21.

Sec. 1307.21 Procedure for disposing of controlled substances.

(a) Any person in possession of any controlled substance and desiring or required to dispose of such substance may request the Special Agent in Charge of the Administration in the area in which the person is located for authority and instructions to dispose of such substance. The request should be made as follows:

(1) If the person is a registrant required to make reports pursuant to part 1304 of this chapter, he shall list the controlled substance or substances which he desires to dispose of on the ``b'' subpart of the report normally filed by him, and submit three copies of that subpart to the Special Agent in Charge of the Administration in his area.

(2) If the person is a registrant not required to make reports pursuant to part 1304 of this chapter, he shall list the controlled substance or substances which he desires to dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in his area; and

(3) If the person is not a registrant, he shall submit to the Special Agent in Charge a letter stating:

(i) The name and address of the person;

(ii) The name and quantity of each controlled substance to be disposed of;

(iii) How the applicant obtained the substance, if known; and

(iv) The name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant, if known.

(b) The Special Agent in Charge shall authorize and instruct the applicant to dispose of the controlled substance in one of the following manners:

(1) By transfer to person registered under the Act and authorized to possess the substance;

(2) By delivery to an agent of the Administration or to the nearest office of the Administration;

(3) By destruction in the presence of an agent of the Administration or other authorized person; or

(4) By such other means as the Special Agent in Charge may determine to assure that the substance does not become available to unauthorized persons.

(c) In the event that a registrant is required regularly to dispose of controlled substances, the Special Agent in Charge may authorize the registrant to dispose of such substances, in accordance with paragraph

(b) of this section, without prior approval of the Administration in each instance, on the condition that the registrant keep records of such disposals and file periodic reports with the Special Agent in Charge summarizing the disposals made by the registrant. In granting such authority, the Special Agent in Charge may place such conditions as he deems proper on the disposal of controlled substances, including the method of disposal and the frequency and detail of reports.

(d) This section shall not be construed as affecting or altering in any way the disposal of controlled substances through procedures provided in laws and regulations adopted by any State.

Sec. 1307.22 Disposal of controlled substances by the Administration.

Any controlled substance delivered to the Administration under Sec. 1307.21 or forfeited pursuant to section 511 of the Act (21 U.S.C. 881) may be delivered to any department, bureau, or other agency of the United States or of any State upon proper application addressed to the Administrator, Drug Enforcement Administration, Department of Justice, Washington, DC 28083. The application shall show the name, address, and official title of the person or agency to whom the controlled drugs are to be delivered, including the name and quantity of the substances desired and the purpose for which intended. The delivery of such controlled drugs shall be ordered by the Administrator, if, in his opinion, there exists a medical or scientific need therefor.

Sec. 1307.31 Native American Church.

The listing of peyote as a controlled substance in Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the Native American Church so using peyote are exempt from registration. Any person who manufactures peyote for or distributes peyote to the Native American Church, however, is required to obtain registration annually and to comply with all other requirements of law.