Compounding Pharmacies Continue to Pose Regulatory Challenges

FDA Needs To Know How 503B Compounders Work

BY Phil Crooker, J.D., Vice President, Technical, Parexel - 8.28.19 -

FDA recently published a notice in the Federal Register regarding proposals to collect information during proposed research initiatives to understand challenges and opportunities encountered by 503B compounding pharmacies (see the notice here).

In the notice, FDA contends that five years after Congress passed the Drug Quality and Security Act (DQSA) which added the new category of 503B compounding pharmacies, the industry is still relatively small and is experiencing growth and market challenges. Based on publicly available information from the FDA website, there are only 78 503B facilities that are currently registered with FDA and this number has been fairly static.

Many of these growth and market challenges are related to the regulatory oversight that the FDA uses to inspect the 503B facilities. Until such time as new CGMP regulations are published that are specific to 503B compounding pharmacies, similar to how the FDA developed and published CGMP regulations for positron emission tomography (PET) drugs, the FDA is using the CGMP regulations that are also used for conventional large-scale commercial manufacturing to guide the inspections for 503B compounding pharmacies. As a result, of the 78 registered 503B outsourcing facilities, 15 (or about 19%) have received some type of regulatory action (a Warning Letter, Untitled Letter or Regulatory Meeting). Three facilities are now under the jurisdiction of the federal courts after a consent decree was entered and one facility has ceased operations (see FDA website).  

Yet inspections of 39 registered facilities (50%) remain in an “open” status and could result in some further type of regulatory action, adding additional pressures on growth and the ability to provide a reliable supply of compounded drugs.

At a recent public meeting held by FDA to discuss the agency’s current proposed CGMP policies for outsourcing facilities, industry trade groups remarked that these “open” inspections impact a 503B facility’s business operations and its ability to obtain state licenses and enter group purchasing organization (GPO) agreements (see presentation by OFA).  

Further complicating the business outlook and regulatory certainty for 503B facilities has been comments from former FDA Commissioner Scott Gottlieb that the FDA would tailor the CGMP regulations to the specific operations being conducted at the 503B facilities (see report by Akin Gump).  Using one consistent regulatory standard for CGMP for all 503B facilities was also a point raised at the public meeting by the industry trade groups

It’s an opportune time for 503B facilities to engage the FDA and provide their input into how FDA would conduct research to help the agency address challenges and opportunities that face 503B facilities. The Federal Register notice includes 10 questions that FDA might use in its research. This is the time for the 503B industry to review these questions, make changes, propose additional questions or recommend that certain questions are not relevant or out of scope for FDA research. Despite legislation, myriad new guidance, enforcement and public meetings, there is still much to accomplish – including new regulations - to meet the goals of the DQSA. FDA and the public would benefit from a much better understanding of how this industry is operating and will need to operate in the future to meet the needs of patients in the growing number of situations when compounded drugs are essential for public health.

About the Author:

Philip Crooker, Vice President, Technical - Regulatory

Philip Crooker, Vice President, Technical - Regulatory

Mr. Crooker is a scientifically-trained drug development attorney with extensive regulatory and private sector experience in global large-cap, mid-size specialty and closely held pharmaceutical and biotechnology companies. 

Mr. Crooker has accumulated extensive global professional and practice experience for 21 years in applying laws, regulations, and policy to successfully solve complex problems confronting pharmaceutical and biotechnology firms engaged in all stages of product development; chemistry, manufacturing and controls (CMC) and product quality strategy; the regulatory approval process and health authority engagement; product commercialization and lifecycle management; and drug manufacturing compliance and enforcement for both conventional commercial manufacturers and compounding pharmacies.

Mr. Crooker readily identifies, analyzes and capably resolves complex legal, regulatory, and technical issues in a high risk and heavily regulated environment.  He has a proven record of effectively counseling and communicating with organizations on the analysis of issues at the interface of product development and commercialization, regulation, and business; creating successful technical, regulatory and compliance strategies for all stages of pharmaceutical product lifecycle management; assessing and integrating new product acquisitions; and leading and growing business functions

Mr. Crooker has presented at numerous meetings for the American Association for Pharmaceutical Scientists (AAPS) and participates in the International Society of Pharmaceutical Engineering (ISPE), the Food and Drug Law Institute (FDLI) and the American Society for Testing and Materials (ASTM) and holds an undergraduate degree in chemistry and a law degree.  He remains an active member of the California Bar and has also been admitted to the U.S. District Court for the Central District of California.

We are always available for a conversation.