FDA has changed its practices related to inspecting compounding pharmacies

Compounding pharmacies are known for providing various aspects of medication access to patients with unique needs. For example, tablets commonly have inactive ingredients called excipients that do not provide direct medical relief, but instead offer benefits such as stability so the tablet itself does not fall apart in the bottle. Some patients may be allergic to certain excipients, and some may not be able to swallow big tablets, and thus must take the medication in a uniquely available way: compounded by the pharmacy to provide maximum benefits for patients. If the standards for a “503A” type of compounding pharmacy(aka. a traditional compounding pharmacy) are met, then the pharmacy is exempt from certain other requirements such as following the standards for wholesale manufacturers (aka. Current Good Manufacturing Practices, or “cGMP”), as well as labeling of these medications, and/or requiring approval from the FDA of the compounded medication as a new drug. If the standards for the “503B” type of compounding pharmacy (aka. an outsourcing facility) are met, then it will only be exempt from the labeling and approval requirements of the compounding statutes.

With the importance of compounding pharmacies and the potentially dangerous consequences of unfulfilled standards, the FDA commonly investigates compounding pharmacies to enforce proper safety measures. If the FDA investigates your pharmacy and there are potential violations, then the FDA will issue a Form 483 list of inspectional observations, noting these potential violations and allowing the pharmacy a window of opportunity to correct these issues. However, previously the FDA included violations of the cGMP standard, which did not need to be met for traditional compounding pharmacies. Fortunately, there is a very recent change to these inspections and subsequent reports.Effective August 1, 2016, FDA investigators will make “preliminary assessment of whether such entities are compounding their human drugs in accordance with” certain conditions of section 503A before closing the inspection. If a Form 483 is issued, then the investigator will not include cGMP derivations unless it also appears that the firm compounds non-503A drugs. Therefore, as long as a traditional compounding pharmacy is properly performing the actions of a 503B outsourcing facility, then any potential cGMP violations will not be considered. This is a tailored approach to some concerns by traditional compounding pharmacies, and it is encouraging to see the FDA listen to some of its critics in developing this change to inspecting compounding pharmacies.

Questions, comments, or concerns regarding your pharmacy? We can help! Contact us at Pasricha & Patel at greg@pasricha.com or call the Edison office at 732-593-6200.

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