Short answer. Yes to both. We are highly regulated. Long answer below.

Pharmacy compounding is not a new phenomenon. It goes back a thousand years or more, to the very beginnings of pharmacy practice. In an ancient world in which standardized, mass-produced drugs were not yet dreamed of, compounding was pharmacy — mixing ingredients to create a treatment for a specific person or animal.

Pharmacy practice has come a long way since then, and so has pharmacy compounding. What has remained consistent is the role of compounding in healthcare. These days, upon an order from a prescriber, traditional compounding pharmacies use pure ingredients to create customized medications for a specific human or animal patient.

Pharmacy compounding for human patients, then, is a legacy therapy that existed well before the establishment of mass-produced drugs and government regulation of those drugs. But being a legacy does not mean it’s obsolete or unimportant; in fact, the American healthcare system depends on pharmacy compounding. Compounding is an appropriate and essential therapy option when, in the judgement of a prescriber, an FDA-approved, mass-produced drug is not suited to a specific human patient’s need. This is why it is enshrined in the U. S. Food, Drug & Cosmetic Act and permitted so long as certain criteria are met.

From the simple addition of grape flavoring for a child’s medication to the compounding of critical medications in shortage, compounding pharmacies are highly regulated, adhering to high standards of quality and compliance. Just as with pharmaceutical manufacturers, the active pharmaceutical ingredients — API — that compounding pharmacies use must come from FDA-registered facilities and manufacturers. Compounding labs and the equipment in them are subject to exacting regulation and are inspected by state boards of pharmacy and by the FDA. In addition, pharmacy compounders must adhere to state laws and regulations governing compounding as well as standards promulgated by the United States Pharmacopoeia, the internationally recognized standards-setting organization. In fact, many (if not all) states have expressly adopted some or all USP standards directly into their laws.  The lives and health of millions of Americans are enriched daily by compounded medications ordered by a physician or other prescriber.