FAQs about Pharmaceutical Compounding

compounding pharmacies

What are compounded medications?

Compounded medications are customized treatments produced at compounding pharmacies by licensed pharmacists. The treatments are prescribed by a licensed medical practitioner and then created from scratch by the pharmacist using modern technology and sterile production techniques.

The benefits of compounded medications are many; they can be customized for a patient based on their allergies, preferred delivery method, taste preferences, and other considerations that may prevent the patient from using a commercial preparation. In other cases a medical provider may want to combine two or more medications into one treatment, or the pharmacy can provide a drug that was taken off of the market.

Are compounded medicines safe?

Compounded medicines are safe, as long as the facilities that produce them are operating based on state law. The FDA does not oversee compound pharmacies; instead they are regulated by each state.

However, states have very specific guidelines usually set by their Board of Pharmacy, and these guidelines are used to regulate the safety of medication production at compound pharmacies.

Also, the DEA regulates controlled substances that are used for drug production. As long as the pharmacy is licensed to operate in the state that it resides in, its medications are safe because it has been approved to operate in its state.

What drugs do compounding pharmacies make?

They make several different types of drugs including bio-identical hormones, customized pain medications, sports medicine treatments, pediatric medications, veterinary medications, and many other types.

Virtually any medication that is available commercially can be compounded, with the exception of certain types of medications such as extended release tablets that may be more difficult to reproduce. Also, one drug can be created in many different medication forms.

For example, a drug that is commercially available only as a pill can be compounded into a liquid, injection, or other form that may be more suitable for a patient.

What organization issues the standards for compounding?

The United States Pharmacopeial (USP) Convention is responsible for issuing the standards that are used by compounding pharmacies to direct their practices. The USP convention does not directly oversee pharmacies; instead it issues the standards and publications that licensed pharmacists can then use to developer their production methods.

The organization offers guidance on how to prevent contamination, sterile production techniques, how to safely create medications, how to test and verify preparations and much more. The standards are used by pharmacists, nurses, pharmacist technicians and any other worker or medical provider who may come in contact with treatments.

Why are compound medications needed if there are FDA approved medicines?

There are hundreds of thousands of medical applications for compound medicines. In many cases, there is simply no other alternative other than creating a customized compound. For instance, there may be a specific medication that has been taken off the market, but is still available in its raw form to be produced at a compound pharmacy.

In other cases patients may be allergic to a commercial medication and there may not be any other alternatives available. In spite of the lack of FDA oversight, compound medicines are just as effective and safe as most commercial drugs, as long as the compounding facility is licensed.

Shouldn’t the FDA regulate them more strictly?

The regulations for pharmaceutical compounding are already quite strict and there is not much variation between each state. Each Board of Pharmacy has detailed knowledge of the requirements for safe and sterile medication production, which are based on the USP production guidelines.

One could argue that this is even more effective than requiring the FDA to regulate compounding facilities, as the FDA has limited resources and would likely not be able to sufficiently regulate them. The current method of regulation is very effective and production related problems with compounded medicines are extremely rare.

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