(b) In order to claim exemption from payment of a registration or reregistration fee, the registrant shall have completed the certification on the appropriate application form, wherein the registrant's superior (if an individual) or officer (if an agency) certifies to the status and address of the registrant and to the authority of the registrant to acquire, possess, or handle controlled substances.

(c) Exemption from payment of a registration or reregistration fee does not relieve the registrant of any other requirements or duties prescribed by law. [36 F.R. 7778, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971; 36 F.R. 18728, Sept. 21, 1971; 38 F.R. 756, Jan. 4, 1973]

REQUIREMENTs for RegistrATION

§ 301.21

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 §§ 301.24-301.29. 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.)

[36 F.R. 7778, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971]

§ 301.22 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 (other than research described in subparagraph (6) of this paragraph) with controlled substances listed in schedules II through V;

(5) Conducting instructional activities with controlled substances listed in schedules II through V;

(6) Conducting research with narcotic drugs listed in schedules II through V for the purpose of continuing the dependence on such drugs of a narcotic

drug dependent person in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program pursuant to a Notice of Claimed Investigational Exemption for a New Drug approved by the Food and Drug Administration;

(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; and

(10) Exporting controlled substance listed in schedules I through IV.

(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 obtained 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 nonnarcotic 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 § 301.33 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 § 301.26, 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 (other than research described in paragraph (a) (6) of this section) 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 § 301.26, and to conduct instructional activities with controlled substances;

(6) A person registered to dispense controlled substances listed in schedules II through V shall be authorized to conduct research (other than research described in paragraph (a) (6) of this section) and to conduct instructional activities with those substances.

(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.

[36 F.R. 7778, Apr. 24, 1971, as amended at 36 F.R. 18728, Sept. 21, 1971; 37 F.R. 15918, Aug. 8, 1972; 38 F.R. 756, Jan. 4, 1973]

§ 301.23 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.

[36 F.R. 7778, Apr. 24, 1971, as amended at 36 F.R. 18728, Sept. 21, 1971]

§ 301.24 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 § 304.02 of this chapter (other than an intern, resident, foreign-trained physician, or physician on the staff of a Veterans Administration facility or physician who is an agent or employee of the Health Bureau of the Canal Zone Government), who is an agent or employee of another practitioner registered to dispense controlled substances may,

when acting in the usual course of his employment, administer and 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 practices, under the registration of the employer or principal practitioner in lieu of being registered himself. (For example, a pharmacist employed by a pharmacy need not be registered individually to fill a prescription for controlled substances if a pharmacy is so registered.)

(c) An individual practitioner, as defined in § 304.02 of this chapter, who is an intern, resident, or foreign-trained physician or physician on the staff of a Veterans Administration facility or physician who is an agent or employee of the Health Bureau of the Canal Zone Government, may dispense, administer and prescribe controlled substances under the registration of the hospital or other institution which is registered and by whom he is employed in lieu of being registered himself, 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 intern, resident, or foreign-trained physician to dispense or prescribe under the hospital registration and designates a specific internal code number for each intern, resident, or foreign-trained physician so authorized. The code number shall consist of numbers, letters, or a combination thereof and shall be a suffix to the institution's BNDD registration number, preceded by a hyphen (e.g., APO 123456–10 or APO123456A12); 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.

[36 F.R. 18728, Sept. 21, 1971, as amended at 37 F.R. 15918, Aug. 8, 1972]

§ 301.25 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 306 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 offcial 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.

[36 F.R. 7778, Apr. 24, 1971, as amended at 36 F.R. 18729, Sept. 21, 1971; 38 F.R. 756, Jan. 4, 1973]

(a) The requirement of registration is waived for the following persons in the circumstances described in this section:

(1) Any officer or employee of the Bureau, any officer of the U.S. Bureau of Customs, any officer or employee of the United States Food and Drug Administration, and any other Federal officer who is lawfully engaged in the enforcement of any Federal law relating to controlled substances, drugs or customs, and is duly authorized to possess controlled substances in the course of his official duties; and

(2) Any officer or employee of any State, or any political subdivision or agency thereof, who is engaged in the enforcement of any State or local law relating to controlled substances and is duly authorized to possess controlled substances in the course of his official duties.

(b) Any official exempted by this section may, when acting in the course of his official duties, possess any controlled substance and distribute any such substance to any other official who is also exempted by this section and acting in the course of his official duties.

(c) Any official exempted by this section may procure any controlled substance in the course of an inspection, in accordance with § 316.03 (d), or in the course of any criminal investigation involving the person from whom the substance was procured.

(d) In order to enable law enforcement agency laboratories to obtain and transfer controlled substances for use as standards in chemical analysis, such laboratories must obtain annually a registration to conduct chemcal analysis. Such laboratories shall be exempted from payment of a fee for registration. Laboratory personnel, when acting in the scope of their official duties, are deemed to be officials exempted by this section and within the activity described in section 515(d) of the Act (21 U.S.C. 885(d)). For purposes of this paragraph, laboratory activities shall not include field or other preliminary chemical tests by officials exempted by this section.

(e) Laboratories of the Bureau shall obtain annually a registration to conduct chemical analysis in accordance with paragraph (d) of this section. In addition to the activities authorized under a registration to conduct chemical analysis pursuant to § 301.22(b)(4), laboratories of the Bureau shall be authorized to manufacture or import controlled substances for any lawful purpose, to distribute or export such substances to any person, and to import and export such substances in emergencies without regard to the requirements of Part 312 of this chapter if a report concerning the importation or exportation is made to the Distribution Audit Branch of the Bureau within 30 days of such importation or exportation.

§ 301.27 Exemption of civil defense officials.

(a) The requirement of registration is waived for any official of a civil defense or disaster relief organization who, in the course of his official duties, is authorized to:

(1) Maintain, and distribute for such maintenance, controlled substances held for emergency use; or

(2) Procure controlled substances for the purpose of maintaining supplies for emergency use, provided that all of such procurement is from the U.S. General Services Administration and in accordance with the rules of the U.S. Office of Emergency Preparedness.

(b) The requirement of registration is waived for any official of a civil defense or disaster relief organization during a state of emergency or disaster within his jurisdiction proclaimed by the President or by a concurrent resolution of the Congress, which official, in the course of his official duties, during such emergency or disaster, is authorized to:

(1) Dispense controlled substances; or

(2) Procure or distribute controlled substances, provided that all such procurement is on a special "Civil Defense Emergency Order Form," as described in this section.

(c) Civil Defense Emergency Order Forms shall be furnished by the U.S. Office of Emergency Preparedness and will contain the name of the civil defense or disaster relief organization. Such forms may be used and are valid only during a state of emergency or disaster proclaimed by the President or by a concurrent resolution of the Congress for the area in which the organization using such forms has civil defense or disaster relief jurisdiction, who shall state his position and the nature and legal designation of the emergency or disaster. Such forms may be filled by any person registered under the Act. The organization shall, upon the execution of a Civil Defense Emergency Order Form, be deemed to be registered under the Act for purposes of recordkeeping pursuant to Part 304 of this chapter.

(a) If acquired by and dispensed under the general supervision of a medical officer described in paragraph (b) of this section, or the master of the vessel under the circumstances described in paragraph (d) of this section, controlled substances may be held for stocking, be maintained in, and dispensed from medicine chests, first aid packets, or dispensaries:

(1) On board any vessel engaged in international trade or in trade between ports of the United States and any merchant vessel belonging to the U.S. Government;

84-073-73—2

(2) On board any aircraft operated by an air carrier under a certificate of permit issued pursuant to the Federal Aviation Act of 1958 (49 U.S.C. 1301); and

(3) In any other entity of fixed or transient location approved by the Director as appropriate for application of this section (e.g., emergency kits at field sites of an industrial firm).

(b) A medical officer shail be:

(1) Licensed in a State as a physician; (2) Employed by the owner or operator of the vessel, aircraft or other entity; and

(3) Registered under the Act at the location of the principal office of the owner or operator of the vessel, aircraft or other entity.

(c) A registered medical officer may serve as medical officer for more than one vessel, aircraft, or other entity under a single registration, unless he serves as medical officer for more than one owner or operator, in which case he shall attain a separate registration at the location of the principal office of each such owner or operator.

(d) If no medical officer is employed by the owner or operator of a vessel, or in the event such medical officer is not accessible and the acquisition of controlled substances is required, the master of the vessel, who shall not be registered under the Act, may purchase controlled substances only with the approval of, and upon special order forms (HSM590, formerly PHS-2341) provided by, a medical officer of the U.S. Public Health Service.

(e) Any medical officer described in paragraph (b) of this section shall, in addition to complying with all requirements and duties prescribed for registrants generally, prepare an annual report as of the date on which his registration expires, which shall give in detail an accounting for each vessel, aircraft, or other entity, and a summary accounting for all vessels, aircraft, or other entities under his supervision for all controlled substances purchased, dispensed or disposed of during the year. The medical officer shall maintain this report with other records required to be kept under the Act and, upon request, deliver a copy of the report to the Bureau. The medical officer need not be present when controlled substances are dispensed, if the person who actually dispensed the controlled substances is responsible to the medical officer to justify his actions. (f) [Reserved]

(g) Owners or operators of vessels, aircraft, or other entities described in this section shall not be deemed to possess or dispense any controlled substance acquired, stored and dispensed in accordance with this section.

(h) The Master of a vessel shall prepare a report for each calendar year which shall give in detail an accounting for all controlled substances purchased, dispensed, or disposed of during the year. The Master shall file this report with the medical officer employed by the owner or operator of his vessel, if any, or, if not, he shall maintain this report with other records required to be kept under the Act and, upon request, deliver a copy of the report to the Bureau.

acquired

(i) Controlled substances and possessed in accordance with this section shall not be distributed to persons not under the general supervision of the medical officer employed by the owner or operator of the vessel, aircraft, or other entity, except in accordance with § 307.21 of this chapter.

[37 F.R. 15918, Aug. 8, 1972, as amended at 38 F.R. 756, Jan. 4, 1973]

APPLICATIONS FOR REGISTRATION

§ 301.31 Time for application for registration; expiration date.

(a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Director to such person.

(b) Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his registration.

(c) At the time any person is first registered, he shall be assigned to one of 12 groups, which shall correspond to the months of the year. The expiration date of the registrations of all persons within any group will be the last day of the month designated for that group. In assigning any person to a group, the Bureau may select a group the expiration date of which is less than 1 year from the date such person was registered. If the person is assigned to a group which has an expiration date less than 3 months from the date on which the person is registered, the registration shall not expire until 1 year from that expiration date; in all other cases, the registration