Monday, May 6, 2013

Virginia's Amendments to Compounding Laws

General Assembly – HB 2312
HB 2312, sponsored by Delegate Chris Jones and passed
during the 2013 General Assembly session, amends several
sections of law affecting pharmacy. In addition to clarifying the definition of “compounding” in §54.1-3401, the
bill requires the pharmacist-in-charge (PIC) or owner of a
permitted pharmacy or a registered nonresident pharmacy
engaging in sterile compounding to notify the Virginia Board
of Pharmacy of its intention to dispense or otherwise deliver
a sterile compounded drug product into the commonwealth.
Notification may be accomplished by providing a written
statement from the PIC or owner to the Board office. Additionally, following the directions provided on the annual
renewal form, pharmacies will be required to inform the
Board if it will continue dispensing or delivering sterile
compounded drug products into Virginia, and the Board
will be required to maintain this information in a manner
that will allow the production of a list identifying all such
sterile compounding pharmacies. While HB 2312 did not
amend the current allowance for a pharmacist to provide
compounded products to practitioners of medicine, osteopathy, podiatry, dentistry, or veterinary medicine to administer
to their patients in the course of their professional practice,
the bill does add the following language to §54.1-3410.2 H:
Pharmacists shall not engage in the following: . . . 3.The
compounding of inordinate amounts of any preparation
in cases in which there is no observed historical pattern
of prescriptions and dispensing to support an expectation
of receiving a valid prescription for the preparation. The
compounding of an inordinate amount of a preparation
in such cases shall constitute manufacturing of drugs.
HB 2312 further amends §54.1-3434.1 to require pharmacies, upon submission of an application for registration
as a nonresident pharmacy, to submit an inspection report
from an inspection that occurred no more than six months
prior to the date of submission of the application. Also, upon
renewal of the registration, the nonresident pharmacy must
submit an inspection report from an inspection that occurred
no more than two years prior to the date of application for
renewal. The bill further clarifies that the inspection report
must indicate compliance with the Drug Control Act, including United States Pharmacopeia-National Formulary
(USP-NF) standards for sterile and nonsterile compounding.
If the pharmacy has not been inspected within the required
time frame by the regulatory or licensing agency in the
jurisdiction where the pharmacy is located, then the Board
may accept an inspection report or other documentation
from another entity that is satisfactory to the Board, or the
Board may cause an inspection to be conducted by its duly
authorized agent and may charge an inspection fee in an
amount sufficient to cover the costs of the inspection. Lastly,
HB 2312 clarifies the Board’s ability to summarily suspend
or restrict a pharmacy permit.
HB 2312 becomes effective July 1, 2013, and may be
read in its entirety at
Sterile Compounding FAQs
Pursuant to Virginia Code §54.1-3410.2 and Regulation
18VAC110-20-321, both sterile and nonsterile compounding
must be performed in compliance with USP-NF standards.

Source found in Virginia Board of  Pharmacy May 2013 Newsletter

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