Trying Not to Compound the Problem – FDA Releases a Series of Guidance/ Policy Documents

Today, FDA released a set of 5 guidance documents designed to help compounders comply with new statutes, rules and regulations that can impact pharmacies, federal facilities, outsourcing facilities and physicians.  The 5 guidance documents are listed below and the major areas they address are described briefly:

• Draft Guidance: For Entities Considering Whether to Register As Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

This document discusses when a firm should or should not register as an outsourcing pharmacy depending on the type of activities conducted by the facility

• Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

This document addresses repackaging of already approved drugs. FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.

• Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (BLA)

“The draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities or outsourcing facilities mix, dilute or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts (used to treat allergies) without an approved BLA.”  Note that a biologic product that is mixed, diluted or repackaged outside of the express provisions of the approved BLA is considered an unapproved drug that requires approval under its own BLA.

• Draft Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

This may seem too obvious, but outsourcing compounding facilities must meet adverse event (ADE) reporting requirements, and this guidance document explains the ADE reporting scheme for such facilities.

• Draft Memorandum of Understanding Between A State and the U.S. Food and Drug Administration Addressing Certain Distributions of Compounded Human Drug Products

This document describes the responsibilities of the states that sign the MOU in regard to investigation of complaints and monitoring of compounding facilities that ship product out of state and those that dispense inordinate amounts of product intrastate.

Anyone involved in compounding, repackaging, and outsourcing facilities should be well versed in the content of these documents, as compounding is a high priority risk area that FDA has shown significant enforcement action in recent years.  The full set of documents along with the FDA press release on their issuance can be found here.