§ 20-2-52 — Registration of Persons Manufacturing, Distributing or Dispensing Controlled Substances - Standards; Requirements as to Practitioners Conducting Research; Effect of Federal Registration

Alabama § 20-2-52

• Jurisdiction: Alabama
• Title 20: Food, Drugs and Cosmetics
• Ch. 2: Controlled Substances
• Art. 3: Regulation of Manufacture and Distribution

Text

(a) The certifying boards shall register only an applicant certified by their respective boards to manufacture, dispense, or distribute controlled substances enumerated in Schedules I, II, III, IV and V; provided, that the State Board of Pharmacy shall register all manufacturers and wholesalers unless they determine that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the above-mentioned boards shall consider the following factors:
(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific, or industrial channels;
(2) Compliance with applicable state and local law;
(3) Any convictions of the applicant under any federal and state laws relating to any controlled substance;
(4) Past experience in the manufacture or distribution of controlled substances and the existence in the applicant’s establishment of effective controls against diversion;
(5) Furnishing by the applicant of false or fraudulent material in any application filed under this article;
(6) Suspension or revocation of the applicant’s federal registration to manufacture, distribute, or dispense controlled substances as authorized by federal law; and
(7) Any other factors relevant to and consistent with the public health and safety.
(b) Registration under subsection (a) of this section does not entitle a registrant to manufacture and distribute controlled substances in Schedule I or II other than those specified in the registration.
(c) Practitioners must be registered to dispense any controlled substances or to conduct research with controlled substances in Schedules II through V if they are authorized to dispense or conduct research under the laws of this state. The State Board of Health need not require separate registration under this article for practitioners engaging in research with nonnarcotic controlled substances in Schedules II through V where the registrant is already registered under this article in another capacity. Practitioners registered under federal law to conduct research with Schedule I substances may conduct research with Schedule I substances within this state upon furnishing the State Board of Health evidence of that federal registration.
(d) Compliance by manufacturers and distributors with the provisions of the federal law respecting registration (excluding fees) entitles them to be registered under this article.

Legislative History

(Acts 1971, No. 1407, p. 2378, §303; Acts 1976, No. 699, p. 965, §3.)