GDP in the US: FDA Draft Guidance on Wholesaling under Section 503B of the FD&C Act

End of June 2023, the U.S. Food and Drug Administration (FDA) has published a new Draft Guidance for Industry entitled "Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act".

The document is being distributed for comment purposes only. Comments can be submitted until 28 August 2023.

Legal Background

The Drug Quality and Security Act from 2013 created a new section 503B (Outsourcing facilities) in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This paragraph describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from certain statutory requirements.

In one of its Questions and Answers documents, the FDA defines "compounding" as "the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved."

Section 503B(a)(8) of the FD&C Act states the following:

(8) Prohibition on wholesaling
The drug will not be sold or transferred by an entity other than the outsourcing facility that compounded such drug. This paragraph does not prohibit administration of a drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 353(b)(1) of this title.

This paragraph contains several terms that require an interpretation.

Content of the Draft Guidance

The 10-page document is divided into the following main chapters:

• Introduction
• Background
• Policy

In the introduction, the authority writes that "this guidance describes FDA’s interpretation of, and policies concerning, the prohibition on wholesaling in section 503B of the FD&C Act. This guidance also describes examples of how FDA intends to apply section 503B’s wholesaling provision."

In the background part, the FDA states that "the statutory prohibition on wholesaling in section 503B(a)(8) of the FD&C Act helps to ensure that compounding is based on individual patients’ needs, which, in turn, reduces the overall risk of patient harm and helps to preserve the integrity of the U.S. drug approval process."

In the policy section, the main part of the document, the following key terms referring to section 503B(a)(8) of the FD&C Act are defined:

• Sold or transferred
• Entities other than the outsourcing facility
• Administration or dispensing

The part that follows, gives several examples for situations that generally would be subject to the wholesaling prohibition and such that are not prohibited.

To download the Draft Guidance and to submit comments, please go to the FDA website.