FAQ

The FDA defines pharmaceutical compounding as a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.

Questions? Email FDA’s compounding team at compounding@fda.hhs.gov.

According to the FDA, compounded drugs can serve an important medical need for patients who cannot be treated with an FDA-approved medication, such as a patient who has an allergy and needs a drug to be made without a certain dye, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.

Practitioners in hospitals, clinics, and other health care facilities sometimes provide compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat them.

Pharmaceutical compounding give providers the opportunity to:

• Combine therapeutics. Example, improve compliance by writing a prescription to be compounded for a drug cocktail into a single dosage form. And guess what? Your patient save money!
• Personalize dosing. As a prescriber, you may want your patient to take a dose of 1 & 1/4 tablets of a drug. This is the best you can do with commercially available dosing. Did you know compounding can solve all this?
• Tailor dosage forms. Troches, suppositories, gummies, chewable, suspensions are just a few of the dosage form you can choose for your patient.
• Eliminate unwanted ingredients. Is your patient allergic to dyes, preservatives, fragrance, or even generic medications? If so, compounding will be a good solution.
• Provide solutions to product unavailability. Not just drug shortages. Big Pharma is market driven and will only make drugs that have significant market share.
• Enhance patient adherence. Let just say if you have a sick pet, you know the importance of giving the right dosage form.

Compounded drugs are not FDA-approved. This means that FDA does not verify the safety or effectiveness of compounded drugs. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed. 

This is a major reason for prescribers to partner with pharmaceutical compounders that can provide them with as much information to make a patient care decision.

The Pharmacists at Red Apple realize that you need this information while creating the prescription. They came up with an interactive application to achieve this goal.

Various entities may inspect facilities that compound drugs, including state boards of pharmacy and FDA.

Generally, state boards of pharmacy have primary responsibility for the day-to-day oversight of state-licensed pharmacies that are not registered with FDA as outsourcing facilities. FDA does conduct surveillance and for-cause inspections of state-licensed pharmacies that are not registered as outsourcing facilities.

No. Biological products are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act. Federal law does not provide a legal pathway for marketing biologics that have been prepared outside the scope of an approved biologics license application.

Unfortunately No. But guess what? Most compounded medications are far cheaper than commercially available dosage forms.

Workflow.