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Polsinelli - FDA Regulatory

December 2013


Draft Guidance: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act


For more information about this e-Alert, please contact:


Melissa Gilmore




FDA Regulatory Practice Leaders:


Kevin R. Sweeney

Practice Area Chair



Geoffrey D. Fasel

Practice Area Vice Chair



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Following enactment of the Drug Quality and Security Act last month, FDA has quickly issued a new guidance for compounding pharmacies that choose to not register as "outsourcing facilities" and subject themselves to federal oversight. The Draft Guidance lists 10 conditions that pharmacies must follow in order to remain regulated by state Boards of Pharmacy under 21 USC 353A. Remaining under state jurisdiction exempts these "traditional" compounding pharmacies from the requirements of the U.S. Food, Drug, & Cosmetic Act that are generally applicable to drug manufacturers, such as GMP, labeling, and prior new drug approval.

Under the Draft Guidance, in order for FDA not to consider the pharmacy and compounded product subject to federal FDA regulation, the pharmacy must compound:

  1. based on a prescription for an individual patient;

  2. in a pharmacy in limited quantities if there is a history of prescriptions from a licensed practitioner;

  3. in compliance with USP;

  4. compounded using bulk substances from a FDA registered facility;

  5. using substances accompanied by valid certificates of analysis;

  6. in compliance with an USP or NF monograph, if it is not compounded from a bulk substance;

  7. not on the list of products removed from the market;

  8. not "essentially copies of commercially available drug products;"

  9. not a product identified by the FDA as presenting demonstrable difficulties for compounding; and

  10. subject to inspection.

The 5% Rule and Inspections

The Act returns the state of the law to 2002 by imposing the limitations for "inordinate amounts" and "5%" under 353a(b)(3)(B)(i-ii). Under 353a(b)(1)(D) "a drug product may be compounded" if the pharmacist (or physician) "does not compound regularly or in inordinate amounts...any drug products that are essentially copies of commercially available drug products." The phrase "inordinate amounts" is to be defined by the FDA. The 5% limitation provides that a pharmacy may not compound a product unless:

  1. The state where the drug is compounded has a memorandum of understanding (MOU) with the FDA for state investigations of complaints relating to "compounded drug products" distributed out of state; or

  2. The total compounded products distributed out of state do not exceed 5% of the total prescription orders.

FDA states that it "does not intend to enforce the 5% limitation until 90 days after FDA has finalized an MOU and made it available to the State... ."

For More Information

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