Pharmacy Compounding of OTCs:an Oxymoron

Pharmacy Compounding of OTCs:an Oxymoron
Pharmacy compounding continues to be a hot topic. This
is, of course, due to the still new federal Compounding
Quality Act, which amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act). As is widely known, pharmacy
drug compounding is the combination of active and inactive
ingredients only when done for a specific prescription order
for a specific individual patient, or in limited quantities in
anticipation of the receipt of valid prescription orders based
on past history of receiving such orders. Over-the-counter
drugs (OTCs) are those that can be sold without a prescription.
So, can a pharmacy compound OTCs and sell them on
the front end? Simply put, no.
According to Webster’s Ninth New Collegiate Dictionary,
copyright 1983, the definition of “oxymoron” is “a combination
of contradictory or incongruous words. . .” Since pharmacies
can only compound for specific prescriptions, the idea
of compounding OTCs that are sold without a prescription
is directly contradictory to and incongruent with the FD&C
Act compounding laws. This would be manufacturing of
OTCs, which requires full compliance with federal laws for
current Good Manufacturing Practices. So, although you
might have the best recipe for diaper paste or the best remedy
for a skin irritation, unless you have gotten it approved
through the Food and Drug Administration (FDA) process for
manufacture as an OTC, and unless you do it in a properly
licensed manufacturing facility under FDA requirements, if
you decide to whip up a batch and sell it as an OTC, you are
engaged in illegal manufacturing.

quoted from West Virginia Board of Pharmacy December 2014 Newsletter