FDA Releases Long-Awaited Policies on Regulation of Pharmaceutical Compounders

Posted 13 February 2015 | By Alexander Gaffney, RAC 

FDA Releases Long-Awaited Policies on Regulation of Pharmaceutical Compounders

The US Food and Drug Administration (FDA) has announced the release of four guidance documents intended to help increase regulatory oversight of the pharmaceutical compounding industry.


The documents come nearly three years after an outbreak of fungal meningitis was linked back to drug products compounded by the New England Compounding Center (NECC). In the aftermath of that outbreak, legislators passed the Drug Quality and Safety Act (DQSA), which clarified FDA's authority to oversee compounding pharmacies.

The law established a two-part system of compounding oversight. Some compounding pharmacies—referred to as 503A compounders—would continue to be overseen by state regulators, but would be subject to several manufacturing restrictions. Other compounding pharmacies—known as "outsourcing facilities," of 503B compounders—would need to register with FDA and be subject to federal inspections.

Existing Efforts

To date, FDA has issued six guidance documents related to pharmaceutical compounding:

Date IssuedTypeTitle
11/24/2014Final GuidanceFees for Human Drug Compounding Outsourcing Facilities Under the FD&C Act
11/24/2014Final GuidanceRegistration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
11/24/2014Revised Draft GuidanceElectronic Product Reporting for Human Drug Compounding Outsourcing Facilities
7/2/2014Final GuidancePharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act
7/2/2014Proposed RuleAdditions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness 
7/2/2014Draft GuidanceCurrent Good Manufacturing Practice-Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act 

New Guidance

Now the agency is out with five additional documents—four guidance documents and one memorandum of understanding—meant to clarify some of the most essential parts of the DQSA.

Date IssuedTypeTitle
2/13/2015Draft MOUDraft Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Better the State of [insert STATE] and the U.S. Food and Drug Administration 
2/13/2015Draft GuidanceGuidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act  
2/13/2015Draft GuidanceRepackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities 
2/13/2015Draft GuidanceMixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application 
2/13/2015Draft Guidance Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act 

For example, one of the draft guidance documents clarifies which entities should register as an outsourcing facility under the law. The brief guidance notes that any facility involved in the manufacture of sterile drugs needs to register with FDA. Other facilities may do so on a voluntary basis. The provisions of the law were meant to establish a system whereby facilities were encouraged to subject themselves to federal oversight, with the thinking that hospitals and purchasing entities would prefer to purchase drugs from those companies only.

A second guidance explains how companies may properly repackage products produced by compounding pharmacies. FDA said it does not intend to take action against facilities as long as they follow a lengthy set of rules explained in its guidance. For example, the repackaged compounded drug must be a copy of an FDA-approved drug, must be repackaged at a licensed facility and must be repackaged "in a way that does not conflict with approved drug product labeling."

A third guidance is also focused on repackaging, but specifically relates to biological products. It is conceptually similar to the other repackaging guidance.

The fourth and final guidance is focused on adverse event reporting for outsourcing facilities. The guidance clarifies that outsourcing facilities are now responsible for reporting adverse events associated with their products to FDA, including "all serious, unexpected adverse drug experiences." The guidance clarifies that the reporting criteria is nearly identical to the criteria for traditional pharmaceutical manufacturers.

FDA says it will be accepting comments on the guidance documents for the next 90 days.

Categories: Regulatory News

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