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 Code of Federal Regulations (Last Updated: May 6, 2024)
 Title 21 - Food and Drugs
 Chapter I - Food and Drug Administration, Department of Health and Human Services
 SubChapter A - General
 Part 5 - Organization
 Subpart B - Redelegations of Authority from the Commissioner of Food and Drugs

  § 5.44 - Export of unapproved drugs.  

Latest version.

  • (a) The following officials are authorized, under section 802(b) of the Federal Food, Drug, and Cosmetic Act, to approve or disapprove applications to export unapproved new drugs and biological products and to issue notices of receipt of such applications:

    (1) For human drugs assigned to their respective organizations:

    (i) The Director and Deputy Director, Center for Biologics Evaluation and Research (CBER).

    (ii) The Director and Deputy Director, Office of Compliance, CBER.

    (iii) The Director, Deputy Center Director for Review Management, and Deputy Center Director for Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

    (iv) The Director and Deputy Director, Office of Compliance, CDER.

    (2) For new animal drugs assigned to their respective organizations:

    (i) The Director and Deputy Director, Center for Veterinary Medicine (CVM).

    (ii) The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM.

    (b) The following officials are authorized, under section 802(f) of the Federal Food, Drug, and Cosmetic Act, to approve or disapprove an application to export a drug (including a biological product) to be used in the prevention or treatment of a tropical disease:

    (1) For human drugs assigned to their respective organizations:

    (i) The Director and Deputy Director, CBER.

    (ii) The Director and Deputy Director, Office of Compliance, CBER.

    (iii) The Director, Deputy Center Director for Review Management, and Deputy Center Director for Pharmaceutical Science, CDER.

    (iv) The Director and Deputy Director, Office of Compliance, CDER.

    (2) For veterinary drugs subject to their jurisdiction:

    (i) The Director and Deputy Director, CVM.

    (ii) The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM.

    (c) The following officials are authorized, under section 351(h) of the Public Health Service Act, to approve or disapprove an application to export a partially processed biological product:

    (1) The Director and Deputy Director, CBER.

    (2) The Director and Deputy Director, Office of Compliance, CBER.