Alabama Administrative Code
Title 420 - ALABAMA STATE BOARD OF HEALTH
Chapter 420-5-12 - IDENTIFICATION OF DRUG PRODUCTS IN SOLID ORAL DOSAGE FORM FOR WHICH A PRESCRIPTION IS REQUIRED BY FEDERAL LAW
Section 420-5-12-.02 - Exemption Procedure

Universal Citation: AL Admin Code R 420-5-12-.02

Current through Register Vol. 42, No. 11, August 30, 2024

(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.

Author: Tigner Zorn

Statutory Authority: Code of Ala. 1975, § 20-1-150.

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