I get really confused on the differences between compounding pharmacies and outsourcing facilities. I’ve never worked at either, but see a lot of 483s and warning letters. So today I spent some snow day time doing some reading. I then wrote this up as a reminder to myself.

The Drug Quality and Security Act (DQSA) of 2013 introduced significant changes by distinguishing between compounding pharmacies under Section 503A and outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). This distinction is crucial for ensuring the safety and quality of compounded drugs.

Compounding Pharmacies (503A)

Definition and Purpose: Compounding pharmacies are licensed by state boards of pharmacy and primarily focus on creating customized medications for individual patients when commercially available drugs do not meet their needs. These pharmacies must adhere to standards set by the United States Pharmacopeia (USP), such as USP 797 for sterile compounding and USP 800 for hazardous drugs.

Regulatory Framework: Compounding pharmacies operate under the supervision of a licensed pharmacist and require a prescription for each compounded product. They are generally limited to small batches and are not allowed to engage in office-use compounding without a prescription.

Outsourcing Facilities (503B)

Definition and Purpose: Outsourcing facilities, on the other hand, are registered with the FDA and specialize in producing large batches of sterile drugs, often without the need for individual prescriptions. These facilities are designed to address drug shortages and provide complex or rarely compounded preparations to healthcare organizations.

Regulatory Framework: Unlike 503A pharmacies, 503B facilities must comply with FDA’s Current Good Manufacturing Practices (CGMP) to ensure the quality and safety of their products. They are subject to regular FDA inspections and must report on their compounded products.

Recent Regulatory Actions: The Case of ProRx, LLC

This research came about because I was reading a recent warning letter issued to ProRx, LLC, which basically stated they were failing to comply with CGMP regulations for 503B outsourcing facilities. The FDA identified serious deficiencies in sterile drug production practices, posing significant patient safety risks.

Implications for 503B Facilities

The warning letter to ProRx, LLC, serves as a reminder of the high regulatory bar set for 503B outsourcing facilities. Key implications include:

• Enhanced Oversight: The FDA’s ability to inspect and enforce cGMP compliance means that 503B facilities must maintain meticulous quality control and production standards.
• Patient Safety: The primary concern is ensuring that compounded drugs are safe for use. Facilities must address any deficiencies promptly to avoid recalls and protect patient health.
• Partnerships and Supply Chain: The ability of 503B facilities to supply compounded drugs to healthcare organizations and pharmacies relies on their compliance with FDA regulations. Non-compliance can disrupt supply chains and impact patient access to necessary medications.

What I take away from my research is that 503B outsourcing facilities are GMP facilities, and are held to the same standard. Good to know as I evaluate their regulatory actions in the future. I think I’ve tended to dismiss them as not being in the same class of regulatory expectations.

Also, this is the second time this month where I really wonder what regulatory agencies fascination with pharmacists are in GMP facilities. Seems pretty clear to me that being a pharmacist is no indication of any capability around GMP activities.