Alabama Administrative Code Chapter 420-5-12 — Identification of Drug Products in Solid Oral Dosage Form for Which a Prescription Is Required by Federal Law

420 Alabama Department of Public Health

Ala. Admin. Code r. 420-5-12-.01 General

(1) Purpose. To establish the procedure and requirements for exempting drug products from the requirements of the statutory prohibition of Act No. 81-389, § 1, (Code of Ala. 1975, § 20-1-150).

(2) Statutory Prohibition. No drug product in finished solid oral dosage form for which a prescription is required by federal law may be manufactured or commercially distributed within this state unless it has clearly and prominently marked or imprinted on it an individual symbol, number, company name, word, letters, marking, National Drug Code, or any combination thereof, identifying the drug product and the manufacturer or distributor of the drug product. Act No. 81-389, § 1, (Code of Ala. 1975, § 20-1-150).

History

• Author: Tigner Zorn
• Authority: Code of Ala. 1975, § 20-1-150.
• Filed September 1, 1982.

Ala. Admin. Code r. 420-5-12-.02 Exemption_Procedure

(1) An exemption may be obtained by the manufacturer, or distributor who prepares the product in the final finished form for distribution to the public, by letter application to the State Board of Health. Application must include a sworn statement describing the product for which the exemption has been requested, stating the reasons why the particular product cannot be so marked or imprinted. An application must be received under certified mail delivery.

(2) An application will have been granted unless the applicant is notified to the contrary within 60 days following receipt of the application. Should additional information be requested, the 60 days will begin to run upon receipt of the information requested.

(3) All applications, statements, samples, etc., submitted shall become the property of the State Board of Health upon receipt.

History

• Author: Tigner Zorn
• Authority: Code of Ala. 1975, § 20-1-150.
• Filed September 1, 1982.

Ala. Admin. Code r. 420-5-12-.03 Preprinted Prescription Blanks

No manufacturer or distributor of controlled substances or agent thereof as defined by Code of Ala. 1975, § 20-2-2, may give as promotional items or lagniappes or for any other reason, or by any means convey or cause to fall into the possession of any practitioner of the healing arts, any preprinted, product identified prescription blanks which show as being prescribed thereon any substances listed on the Controlled Substances List as promulgated by the State Board of Health as such list may from time to time be amended.

History

• Author: John R. Wible
• Authority: Code of Ala. 1975, § § 20-2-2, 20-2-20, 20-2-54.
• Filed November 19, 1990.