mined by the FDA's Good Current Manufacturing Practices guide — the
compounder will be issued Form 483, which details the problem, and
this information will be listed on fda.gov. Violations are common; at
press time, 50 registered facilities had been issued a 483.
"Merely receiving a deficiency form isn't enough reason to disqualify a
facility," says Mr. Coyne. "Some violations are egregious, like what we
saw in New England, but others are less so, and may only require a
reinforcement of education among staff. The important thing is to
engage in a conversation. Ask the facility to explain what happened,
and what the remedy is to correct the situation. Then you can make an
educated decision."
You can also sign up for the FDA's free MedWatch report
(fda.gov/safety/medwatch), which provides updates on enforcement
actions specific to registered compounders.
Is it accredited? Non-profit credentialing groups offer voluntary
accreditation programs for compounders. One of the leading groups
in this area is the Accreditation Commission for Health Care, which
offers a credentialing option through the Pharmacy Compounding
Accreditation Board. The program, established by 8 of the nation's
leading pharmacy organizations and typically geared for 503A facili-
ties, is based strictly on standards set forth by USP.
Another avenue is available through the National Association of
Boards of Pharmacy, which offers the Verified Pharmacy Program.
This program is specifically designed for 503B pharmacies seeking
licensure in multiple places, as it helps them keep abreast of regulatory
changes in each state. For a breakdown of new credentialing and
inspection authorities, keep an eye on the International Academy of
Compounding Pharmacies website (iacprx.org), which will be unveil-
ing a matrix of available options in the coming months.
9 4 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J A N U A R Y 2 0 1 7
