West Virginia Board of Pharmacy Compounding v. Manufacturing

Compounding Versus Manufacturing:
Do You Have a Prescription?
In view of the relatively recent meningitis outbreak due to
the unsanitary conditions at the New England Compounding
Center (NECC), FDA, Congress, and states have been looking
at the practice of compounding in the states to look for ways to
prevent a future issue such as the one at NECC. Therefore, the
Board felt that a review of the compounding rules may be helpful.
As such, the Board looked at its position at the December
2012 Board meeting, and reaffirmed its support for current laws
in this state covering compounding.
First, the Board fully supports compounding for prescriptions,
and distinguishes it from manufacturing when done for
that purpose. The current statutory definition in current West
Virginia Code §30-5-1b(6) is:
(6) “Compounding” means:
(A) The preparation, mixing, assembling, packaging
or labeling of a drug or device:
(I) As the result of a practitioner’s prescription drug
order or initiative based on the practitioner/patient/
pharmacist relationship in the course of professional
practice for sale or dispensing; or
(ii) For the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale or dispensing; and
(B) The preparation of drugs or devices in anticipation
of prescription drug orders based on routine, regularly
observed prescribing patterns.

Therefore, unless it is for a research, teaching, or other similar
situation that is not for sale or dispensing, pharmacies may
compound only for individual prescriptions, or in anticipation
of their regular and routine prescription-dispensing needs.
Second, looking at the Massachusetts situation as an example,
because of the quantities shipped by the NECC, it appears
they were manufacturing and selling at wholesale, and not for
individual prescriptions. This would be wholly illegal under West
Virginia law unless the pharmacy gets the proper licensures. If
a pharmacy manufactures, it is legal only if the pharmacy gets
licensed as a manufacturer and follows all state and federal
laws governing manufacturing of prescription drugs. Further,
if a pharmacy were to sell its manufactured products, then it
would need to be properly licensed as either a manufacturer
or wholesaler/distributor in the jurisdictions into which it is
sending its product (note, of course, this is different than the
exception to wholesaling drugs where a pharmacy is simply
making distributions that do not exceed 5% of their business,
such that a wholesale license is not required).
Third, in order to protect the safety of the public, naturally,
great scrutiny is put on manufacturers for good manufacturing
practices and standards. Likewise, compounding must be done
in a safe manner to protect the patient. Rule §15-1-18 sets
minimal standards in West Virginia for sanitary regulations in
the pharmacy. Further, Rule §15-1-16 governs compounding
in this state, which, among other things, requires in Subsection
16.3 that “. . . [t]he environment shall facilitate controlled
aseptic conditions and meet all standards of the United States
Pharmacopeial Convention (USP). . .” That is why when
inspecting a compounding pharmacy, the Board looks for USP
Chapters 795 and 797 compliance (flow hoods, donning and
doffing antechambers, sterility, etc).
In summary, if you do compounding, be sure you have a
prescription for each shipment to a patient. Make sure you
are doing it in a clean and safe environment, and are properly
handling the materials and instruments used to serve your
patients. Compounding is at the heart of the practice of pharmacy,
and to keep it there, every person involved in the process must
do his or her best to safeguard the art by keeping the safety of
the patient first and foremost at all times.

Source West Virginia Board of Pharmacy March 2013 Newsletter