No. 1145 Update on Pharmacy
Compounding
On May 7, Governor Jay Inslee signed into law, effective
immediately, House Bill 1800 that addresses resident and
nonresident pharmacy compounding.
The law defines “manufacture” to include the distribution
of a licensed pharmacy compounded drug product to other
state-licensed persons or commercial entities for subsequent
resale or distribution, unless a specific product item has approval of the Board. The term “manufacture” excludes:
(a) activities of a licensed pharmacy that compounds a
product on or in anticipation of an order of a licensed
practitioner for use in the course of their professional
practice to administer to patients;
(b) the practice of repackaging, by a licensed pharmacy,
commercially available medication in small, reasonable quantities for a practitioner legally authorized to
prescribe the medication for office use only;
(c) distribution of a drug product that has been compounded by a licensed pharmacy to other appropriately
licensed entities under common ownership or control of
the facility in which the compounding takes place; or
(d) delivery of finished and appropriately labeled compounded products dispensed pursuant to a valid prescription to alternate delivery locations, other than the
patient’s residence, when requested by the patient, or
the prescriber to administer to the patient, or to another
licensed pharmacy to dispense to the patient.
Furthermore, the law added that any medicinal products
that are compounded for patient administration or distribution
to a licensed practitioner for patient use or administration
must meet, at a minimum, the standards of the official United
States Pharmacopeia as it applies to nonsterile products and
sterile administered products.
The Board recently announced its intent to engage in
rulemaking. The Board will evaluate nationally recognized
pharmaceutical compounding standards as it updates and
establishes enforceable practice and quality standards for
the compounding of sterile and nonsterile preparation in all
pharmacy practice. Given the scope of the work at state and
federal levels on issues related to compounding pharmacy
business models and patient safety, the Board anticipates
clarifying this area of pharmacy practice for practitioners
in due course.
quoted from Washingon Board of Pharmacy July 2013 Newsletter
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