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Aug 26, 2016

A Brief Summary of Recent FDA Compounding Pharmacy Guidance and Regulatory Activity

By: Derek Davis and Sarah Barnes, 2017 Pharm D. Candidate

In response to the New England Compounding Center meningitis outbreak, Congress passed the Drug Quality and Security Act (DQSA) in November 2013, which finally authorized the FDA to assert some degree of regulatory authority over compounding pharmacies and created a distinct new class of compounding facilities called outsourcing facilities. Since the passing of the DQSA, the FDA has inspected hundreds of compounding  and outsourcing facilities, overseen more than 85 recalls, and issued over 200 FDA Forms 483 and 75 warning letters.

In 2016 alone, the FDA has issued two interim guidances and six draft guidances for industry illustrating their current thinking in regards to certain topics in Section 503A and 503B of the Food Drug and Cosmetic Act (FDCA).  Section 503A covers traditional compounding pharmacies that make non-sterile human drug products by “prescription only” or in “regular amounts” do not have to follow Current Good Manufacturing Practices (CGMP), and have certain restrictions on interstate distribution. Section 503B encompasses outsourcing facilities that make sterile and non-sterile products with or without a prescription, are required to follow CGMP, and may distribute their products more widely out of state. Compounding pharmacies under section 503A or 503B must meet the conditions under their respective sections in order to be exempt from having to submit new drug applications for each new compounded product under the Food and Drug Cosmetics Act.  This Article will briefly summarize the most recent efforts by the FDA to issue guidance on how it intends to further regulate Compounding Pharmacies.

In April 2016, three draft guidances were posted concerning: (1) the definition of “facility” under section 503B, (2) regulations concerning hospital and health system compounding, and (3) prescription requirements under section 503A.  These guidances can be summarized as follows:

  • Under section 503B, a facility, defined as one geographic location or address, cannot divide its site into multiple sections that perform both 503A and 503B compounding. Facilities registered as outsourcing facilities indicate that all compounded products are to be regulated under section 503B. All of the products in an outsourcing facility must meet conditions under section 503B or none of the products qualify for exemption. It is best to separate 503A and 503B facilities so the standards under which they were compounded are clear to anyone who wants to know.
  • Under section 503A, hospital and health systems are eligible for exemption provided that the healthcare facility and pharmacy are owned and controlled by the same entity and that the healthcare facility is within a one mile radius of the compounding pharmacy. Anything outside of the one mile radius is considered manufacturing and is not exempt from manufacturing requirements.
  • The guidance on prescription requirements states that compounding pharmacies looking to be exempt under 503A must receive a valid prescription from a licensed physician who indicates the patient’s name and that it is medically necessary. It also limits the amount of prescriptions that are allowed to be made in advance to a 30-day supply provided that this supply is based on a history of normal supply from a 30-day period over the past year.

In June, 2016, the FDA posted the final guidance on the interim policy on compounding using bulk drugs under section 503A and 503B, which allows the FDA to place restrictions on and develop a list of bulk substances eligible for exemption under those sections. The FDA evaluates nominated drugs based off of chemical characterization, safety issues, historical use, and evidence of effectiveness or lack thereof. Until a substance has been evaluated and identified in a final rule as being included or not include don the 503A or 503B bulks list, the FDA does not intend to take action against compounding facilities. 

More recently, the FDA published a draft guidance under section 503A and 503B about compounding products that are “essentially copies of approved drug products.” The FDA considers a compounded drug product to be essentially a copy if the product has the same active ingredient, same or easily substitutable dosage strength, and same route of administration. If a pharmacy under 503A compounds a product that is essentially a copy with only a minor change, the prescriber needs to document on the prescription that the change makes a significant difference in the patient and the exact reason for making the change. All of the aforementioned rules apply for outsourcing facilities under section 503B with one minor adjustment: since outsourcing facilities can compound without receiving a prescription ahead of time, the facility must obtain a statement from the practitioner specifying the changes necessary for treatment in a specific population and that these compounded products will only be administered to the patients for whom this change is needed. Finally, the FDA published a draft guidance in August that identifies what the FDA would consider to be insanitary conditions inside of a compounding pharmacy or outsourcing facility. All of the policies outlined in this guidance are already required of compounding pharmacies under USP <795> for non-sterile compounding and USP <797> for sterile compounding, and these policies were generally enforced by compounding pharmacy’s State board until this year.

Over the next few years, compounding pharmacies can expect the FDA to slowly increase its regulatory grasp on the compounding of human drug products.

For questions about pharmacy and pharmaceutical industry related matters, Derek Davis can be reached at