503A Pharmacies


503A pharmacies were mentioned 31 times in FDA Commissioner Scott Gottlieb’s testimony before U.S. House of Representatives Subcommittee on Health, Jan 30, 2018

Commissioner Gottlieb states (Examining implementation, 2018, p. 5):

For example, during our initial inspections, we have seen vermin, such as cockroaches, in the area where employees prepare for sterile processing; employees processing sterile drugs with exposed skin that sheds particles and bacteria; contamination, including bacteria and mold, in the environment where sterile drugs are produced; and much more. In some cases, pharmacies that produce drugs under these conditions ship them to healthcare facilities and patients nationwide. While we have seen problematic conditions at both 503A and 503B facilities, the majority of the most concerning findings were associated with those regulated under section 503A. 

These and similar violations have led to many cases of serious patient harm. Despite a heightened level of oversight activity, FDA has received a steady stream of reports of serious adverse events related to compounded drugs since 2012, mostly associated with pharmacies regulated under section 503A [bold added].

Other examples of patient safety issue resulting from drugs compounded by 503A facilities included (Examining implementation, 2018, pp. 6-7):

  • this past year at least 43 patients experienced vision
    impairment and vision loss after receiving eye injections of a compounded drug that was contaminated by a 503A pharmacy.
  • In 2013, bacterial blood-stream infections developed in 15 patients, and two patients died, after receiving contaminated infusions that FDA subsequently found had been compounded by a 503A pharmacy under inappropriate conditions.

Commissioner Gottlieb infers that the actual number of patient health related issues from 503A compounded drugs is probably higher, because “…the vast majority of 503A pharmacies do not report adverse events to FDA…” (Examining implementation, 2018, p. 7)

With regards to oversight, Commissioner Gottlieb stated the FDA’s position “is to leverage our limited resources to achieve the greatest public health impact. Going forward, we [FDA] are focusing our oversight efforts on outsourcing facilities under section 503B and pharmacies under section 503A that are large-scale, multi-state distributors [bold added].

To identify the large-scale, multi-state distributors, FDA is working with the states to obtain the necessary data to identify who they are [bold added], to help focus FDA inspection and enforcement resources on these subsets of pharmacy compounders that engage in compounding activities that merit FDA oversight.  (Examining implementation, 2018, pp. 11-12)

Regardless if the pharmacy is classified as a 503A or 503B, the FDA has authority to protect the public health from drugs compounded under insanitary conditions (Adulterated drugs or devices, 2017).  If you are a 503A pharmacy, but are considered a large-scale multi-state distributor based on data provided by your state – you are viewed as a higher risk by FDA, and merit additional oversight.  Do not be surprised if/when the FDA shows up to inspect your facilities.

For information on FDA inspection techniques please contact Dr. Van Doel for your pocketbook guide containing the cGMPs and the FDA Compliance Policy Guide for Drug inspections.

Reference:

Adulterated drugs and devices, 21 U.S.C. § 351 (2017).

Examining implementation of the compounding quality act: Hearings before the Subcommittee on Health, Committee on Energy and Commerce, 115th Congress (2018) (testimony of Scott Gottlieb).