FDA Releases Five Draft Documents Related to Compounding and Repackaging Requirements

Food and Drug Administration (FDA) has issued five draft documents related to drug compounding and repackaging requirements under the Drug Quality and Security Act (DQSA). The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians and are as follows.

• Draft Guidance for Industry: For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF) provides guidance to entities considering whether to register as an outsourcing facility. The document provides information about the regulatory impact of registering with FDA as an outsourcing facility.
• Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (PDF) describes the conditions under which FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities, or outsourcing facilities repackage certain drug products.
• Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF) describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act (FD&C Act) when state-licensed pharmacies, federal facilities or outsourcing facilities mix, dilute or repackage specific biological products without an approved Biologics License Application (BLA), or when such facilities or physicians prepare prescription sets of allergenic extracts (used to treat allergies) without an approved BLA.
• Draft Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF) explains adverse event reporting for outsourcing facilities as required by the DQSA.
• Draft Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products (PDF) describes the responsibilities of a state that chooses to sign the memorandum of understanding in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of “inordinate amounts” of compounded human drug products under section 503A of the FD&C Act.

The draft guidance documents will be available for public comment for 90 days, and the comment period for the draft memorandum will be open for 120 days. Additional information on the release of these documents is available in a press release on the FDA website.