Are compounding pharmacies regulated by the FDA? We find the answer in this blog.

Are Compounding Pharmacies Regulated by the FDA?

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Do you need a medication that is no longer being produced? Are you allergic to certain ingredients in mass market medicine? Do you require easy-to-swallow prescriptions that don’t come in pill or tablet forms? You might be considering using a compounding pharmacy. But you might have concerns — are compounding pharmacies regulated by the FDA? In this post, we will discuss which agency directly supervises compounding pharmacies.

What is Compounding vs. Manufacturing?

Traditional compounding of drugs is the preparation of medicines to meet the needs of individual patients.

Pharmaceutical compounding occurs when licensed pharmacists prepare the medicine for patients with a prescription.

Manufacturing refers to the production of drugs on a mass scale with approval from the Food and Drug Administration (FDA).

What Do Compounding Pharmacies Do?

Pharmacies with the proper equipment and training that can do compounding are able to offer more customized treatments for patients. These pharmacies use pharmaceutical-grade ingredients to create non-sterile or sterile preparations.

Non-sterile preparations are used for parts of the body that don’t require absolute sterility. Sterile preparations are used for the eyes or injections, which do require absolute sterility.

Why Would I Need Compounded Medicine?

A drug may be made for a patient who cannot be treated with a FDA-approved medication as a result of an allergy, or because the person is elderly or has difficulty swallowing pills. They may also change the dosage form (e.g., tablet or liquid), or exclude harmful material (e.g., certain dyes).

Are Compounding Pharmacies Regulated by the FDA?

While the FDA puts some guidelines in place for compounding pharmacies to follow, they do not provide direct oversight. In each state, their pharmacy board is actually the direct government entity that regulates and monitors compounding pharmacists — they go through extensive training and supervision under this board.

In Florida, for instance, the Florida Board of Pharmacy is responsible for overseeing and regulating compounding pharmacies in the state. They issue permits, conduct background screenings, and create guidelines for pharmacists.

There is often a valid concern about going to a reputable pharmacy. For pharmacies like ours, who have been in service for over 15 years, we guarantee that we test, check, and vet our FDA-approved suppliers.

Compounding medications cannot be approved by the FDA in their final form since each formula is individual to each patient. In contrast, mass produced medicines can be approved by the FDA since the formula does not change from person to person.

However, every formula from a reputable pharmacy contains FDA-approved ingredients.

Why a Compounding Pharmacy Could Fit Your Needs

Are compounding pharmacies regulated by the FDA? The answer is partially. They mostly receive training and supervision from the pharmacy board in their state.

But a compounding pharmacy with high-quality ingredients and an excellent reputation are your best option for personalized medicine. Pharmacies like Marco Drugs have been in business for over 15 years — rest assured that we will work with your doctor to create a formula that suits your needs.

To talk to our compounding pharmacist, Sonia, call 305-665-4411.