West Virginia Board of Pharmacy Discusses Compounding v. Manufacturing --Compounding for Office Use--Limited Office Use is Permitted --Invoice

Compounding Versus Manufacturing:
Compounding for Office Use
Last quarter, the Board discussed compounding pursuant to
a prescriber’s order (prescription) versus manufacturing. That
article concluded, in part, “ . . . unless it is for a research, teaching
or other similar situation which is not for sale or dispensing,
pharmacies may compound only for individual prescriptions,
or in anticipation of their regular and routine prescriptiondispensing
needs.” However, during the legislative session,
representatives of ophthalmologists expressed concern about
being able to get certain eye drops prepared for their office
use with their patients during certain routine procedures. They
indicated that the solutions are not available on the market and
must be compounded, and that the current law would require
them to write or call in prescriptions for the patient to pick up
and bring with them to appointments. They suggested that this
would be inconvenient and unnecessarily costly for the patients,
often requiring patients to make a second visit because the doctor
would not know until during the initial examination that the
drops would be needed, requiring the exam to be postponed
until the drops could be prescribed, prepared, and picked up
by the patient. As a result, the Board discussed at the March
Board meeting whether to permit limited compounding done
“for office use,” or whether a prescription is always required.
After some discussion, the Board determined that it is in
the best interest of the patient to permit limited compounding
for office use in West Virginia. Therefore, the Board decided
that it would exercise discretion in enforcement with regard
to compounding for that purpose. The motion passed by the
Board stated that this would extend only to minimal amounts of
compounding necessary to fill an order placed by a prescriber

for use in his or her office in the immediate future. No bulk
compounding is permitted under this exception. Further, in no
event, whether for compounded drugs supplied for office use
or any other transfer of prescription drug stock for office use,
may this be documented as a prescription order. Because the
transfer of the compounded product would be done for a prescriber
to have in supply for general office use, the transaction
must be properly documented by invoice the same as any other
wholesale transaction. Finally, this very limited exception does
not in any way change the analysis that all other compounding
must be done for a prescription, or for a research, teaching,
or other similar situation that is not for sale or dispensing, as
required by law.

quoted from West Virginia Board of Pharmacy June 2013 Newsletter

West Virginia Pharmacy Practice Act Receives Makeover with New Practice Act Entitled The Larry W. Border Pharmacy Practice Act

New Practice Act Entitled ‘The Larry W.
Border Pharmacy Practice Act’
The West Virginia Pharmacy Practice Act received a makeover
during the 2013 Regular Legislative Session. The legislature
passed House Bill 2577 on April 13, 2013, setting an
effective date of July 1, 2013. At the time of this writing, the
bill was among the many pieces of legislation that passed that
have to be painstakingly reviewed by the Governor’s Office
as he decides whether to sign them or not. The West Virginia
Board of Pharmacy has been informed that Governor Earl Ray
Tomblin plans to sign the bill, so it will become law, effective
at the beginning of July. If for some reason the bill does get
vetoed, then you can stop reading here . . . that is, unless you
just love the Newsletter so much that you want to see what the
Board would have had to say about it anyway.


continue reading in West Virginia Board of Pharmacy June 2013 Newsletter

Contaminated Compounded Steroid Infects 13 Floridians By Jennifer Wolack, // June 1, 2013

watch video and read story here

American Pharmacy Association Comments on Senate Bill (Pharmaceutical Compounding Quality and Accountability Act

June 01, 2013

APhA comments on Senate draft proposal

The Senate Health, Education, Labor, & Pensions (HELP) Committee on May 15 introduced the Pharmaceutical Compounding Quality and Accountability Act (S. 959) following a full committee hearing and comments from stakeholders, such as APhA, on an April 26 draft proposal.

The Senate compounding bill—a manager’s mark, or updated bill, was released May 20—would draw a line between traditional compounders, which would be regulated primarily by state boards of pharmacy, and “compounding manufacturers,” which would be regulated by FDA; compounding manufacturers would be defined as those that make sterile products without or before a prescription and sell those products across state lines. Pharmacies within health systems would remain regulated as traditional compounders. Compounding manufacturers could not be licensed as pharmacies.

Compounding manufacturers would register with FDA, make products under a pharmacist’s oversight and in compliance with Good Manufacturing Practices, and pay an annual establishment fee to defray the cost of FDA oversight such as inspections and a reinspection fee as needed; small businesses would pay reduced fees.

Traditional compounders would be prohibited from compounding marketed FDA-approved drugs not in shortage, variations of marketed FDA-approved drugs unless they fulfill a specific patient need, or products subject to certain Risk Evaluation and Mitigation Strategies unless it is to fulfill a specific patient need and the compounder uses comparable safety controls. The compounding of certain drugs demonstrably difficult to compound, such as complex dosage forms and biologics, could be prohibited through regulatory rulemaking with comments. Wholesale distribution of compounded products would not be permitted. Marketing of compounded drugs could not be false or misleading.

The Senate compounding bill also would encourage communication among FDA and the states as well as among the states themselves. For more information on the bill, visit the HELP Committee website (www.help.senate.gov).

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