The FDA is dedicating resources to the inspection of 503A and 503B Compounding Pharmacies. Being prepared for an FDA Inspection ensures that your Pharmacy will have a positive outcome.

There is ongoing emphasis by the U.S. Food and Drug Administration (FDA) to inspect compounding pharmacies, both sterile and non-sterile. The Drug and Security Act of 2013 encourages pharmacies that compound to register with the FDA. The agency will classify them as a 503A Compounding Pharmacy (compounding specific to a patient prescription order) or a 503B Compounding Outsourcing Pharmacy (compounding and selling bulk drugs to hospitals and other healthcare facilities). The law was prompted by the deaths of 64 people who received fungus-contaminated steroid medications that were given injections to treat back and joint pain. An additional 750 people in 20 states were sickened by the contaminated drug.

Registering with the FDA as a 503A or 503B Pharmacy is voluntary, but unregistered compounding pharmacies are being inspected as well. The FDA considers a pharmacy compounding for “physician office use” should be registered as a 503B pharmacy.

Pharmacies are being inspected today by multiple agencies - State Boards of Pharmacy, OSHA, the EPA, etc. If you are an Exemplary Provider® accredited pharmacy by The Compliance Team, your pharmacy will be better prepared for inspections.

FDA Inspection Awareness*

FDA inspections are taking place with a focus on sterile compounding (non-sterile compounding pharmacies may also be inspected but are not the focus). The FDA can declare all drugs in a pharmacy as misbranded or adulterated if inspection is refused, delayed or denied.

State Board of Pharmacy inspectors are often accompanying FDA inspectors and performing dual inspections. State inspectors are NOT present to be an advocate for the pharmacy.

For 503A compounding pharmacies, if the FDA determines “insanitary” conditions are present, they can/will evaluate for Current Good Manufacturing Practices (CGMP).

Examples of “insanitary” conditions stated in the FDA Guidance applicable to the production of Sterile and/or Non-Sterile Drugs:

• Vermin (e.g., insects, rodents) observed in production areas or areas immediately adjacent to production.
• Visible microbial contamination (e.g., bacteria, mold) in production area.
• Non-microbial contamination in production area (e.g., glass, shavings, hair).
• Handling beta-lactam, hazardous, or highly potent drugs (e.g., hormones) without providing adequate containment, segregation, and cleaning of work surfaces, utensils and personnel to prevent cross-contamination.
• Production of drugs while construction is underway in an adjacent area without adequate controls to prevent contamination of the production environment and product.

If the FDA does not find patient specific prescriptions for compounded products, they can/will view the pharmacy as a 503B pharmacy and inspect for CGMP. Bulk compounding substances must be USP/NF approved, be manufactured by an establishment registered under 510 of the FD&C Act, and be accompanied by a valid certificate of analysis (COA).

* Visit the FDA website for draft guidance regarding insanitary conditions, and final guidance regarding compounding using bulk substances under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry. Click here for Regulatory Policy Information

Pharmacy accreditation through The Compliance Team will formalize best practices so that you will not be taken by surprise during an inspection. Call us at 215-654-9110.

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