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Feb 23, 2015

FDA Issues New Draft Documents Related to Compounding of Human Drugs

FDA has issued five draft documents related to 
drug compounding that are applicable to pharmacies, 
federal facilities, outsourcing facilities and physicians.
From U.S. Food and Drug Administration

The U.S. Food and Drug Administration has issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.

The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.


Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.

“The draft guidance documents provide information to pharmacies, outsourcing facilities, health care entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

This article is related to the Whitepaper: FDA Guidance for Clinical Investigators, Sponsors and IRBs Regarding Adverse Event Reporting in GCP Regulated Environments. To get the full details, please download your free copy


The documents are:



  • Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
    The draft guidance describes the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal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. Repackaging generally involves taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container. Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs, and the compounding provisions of the FD&C Act do not address repackaging. Therefore, the 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. The draft guidance notes that a biological product that is mixed, diluted or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the PHS Act and may not be legally marketed without an approved BLA. Additionally, the compounding provisions of the FD&C Act do not address biological products subject to licensure under section 351 of the PHS Act. Therefore, the FDA is issuing guidance to describe how it intends to address these practices.
These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities and outsourcing facilities. 

The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.

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