What is compounding pharmacy?
Traditional Compounding (503A Pharmacy)
In traditional compounding, a pharmacist creates a customized medication, most often from pure ingredients, for an individual patient to fill a formal prescription.
Compounding pharmacy is authorized in federal law and for good reasons: Manufactured drugs don’t come in strengths and dosage forms that are right for everyone, and physicians need to be able to prescribe customized medications when, in their judgment, a manufactured drug is not the best course of therapy for a patient.
“I switched to compounded hormones to get much more precise and customized treatment for post-menopausal symptoms. Pharmaceutical solutions are generic designed for a broad population. They are typically a single formula, meaning to get as precise a dose, I would need multiple prescriptions. In addition, using a cream is far less invasive and more effective. Please do not stand in between a woman and her doctor by limiting these critical compounded formulations.”
KAREN B. / Pewaukee, WI
Working with a prescriber, a compounding pharmacist can prepare customized medications and meet the individual needs of children, adults, and animals:
- When the patient is allergic to certain preservatives, dyes, or binders in available off-the-shelf medications.
- When treatment requires tailored dosage strengths or delivery forms.
- When a pharmacist can combine several medications to increase adherence.
- When a patient cannot ingest the medication in its commercially available form.
- When medications require flavor additives to make them more palatable for patients.
- When manufactured drugs are listed in shortage by FDA.
Outsourcing Facilities (503B)
In 2013, Congress passed the Drug Quality and Security Act, creating a new kind of compounding pharmacy, known as 503B outsourcing facilities. A primary difference between these facilities and traditional compounding pharmacies is that 503B pharmacies are licensed by the U.S. Food and Drug Administration (rather than state boards of pharmacy). In addition, they must adhere to manufacturing practices reasonably similar to those of pharmaceutical manufacturers, so they can distribute compounded medicines in bulk for hospitals, physician specialists and clinics, without a patient-specific prescription.
Outsourcing facilities differ from 503As in that they:
- Can source compounded drugs in bulk to hospitals and physician specialists and clinics without a patient-specific prescription.
- Must comply with current good manufacturing practice (CGMP) requirements.
- Are inspected by FDA according to a risk-based schedule.
- Must meet certain other conditions such as reporting adverse events and providing FDA with certain information about the products they compound.