State of Washington Board of Pharmacy Clarifies Pharmacy Compounding Standards

No. 1135 Clarification of Pharmacy
Compounding Standards
The Washington State Board of Pharmacy discussed pharmacy
compounding standards at the February 21, 2013 business
meeting, specifically WAC 246-878-020(4). The Board has
always read Section (4) in conjunction with other subsections
that specifically require a prescription for a compounded
drug. However, it agreed that Section (4), read independently,
could allow a pharmacy to provide compounded products for
a practitioner to give out to individual patients without a prescription
for a specific patient. Because this has clearly been
the belief of some compounding pharmacies in Washington,
the Board decided it will honor this interpretation of the rule.
On January 10, 2013, the Board authorized rulemaking regarding
compounding practices to ensure appropriate standards
are in place to protect the health and safety of the people of
Washington. The Board will invite stakeholders to participate
after filing the “Intent to Initiate Rulemaking” (CR101).

Quoted from State of Washington Board of Pharmacy April 2013 Newsletter

South Dakota Board of Pharmacy Distinction Between Compounding and Manufacturing

Compounding and Manufacturing
Over the last several months, there have been numerous
communications as to the definition of compounding
versus manufacturing. South Dakota Codified Law 36-
11-2(5) defines compounding “as the preparation, mixing,
assembling, packaging or labeling of a drug or drug
device as a result of a practitioner’s prescription drug
order or an initiative based on the pharmacist/patient/
practitioner relationship in the course of professional
practice,” eg, patient-specific. Manufacturing on the
other hand, as defined by the National Association of
Boards of Pharmacy® is “preparation of non-patient specific
products where the primary focus is on the product;
not the patient.” Organizations that are manufacturing
must be permitted by Food and Drug Administration.

Quoted from South Dakota Board of Pharmacy April 2013 Newsletter

North Carolina Board of Pharmacy--Compounding Working Group Report Likely to Be Presented in Spring

Item 2259 – Further Update on
Pharmacy Compounding Matters
Item 2252 of the January 2013 Newsletter updated
North Carolina pharmacists on compounding regulation
matters arising as a result of the New England Compounding
Center tragedy. The Pharmacy Compounding
Working Group has proceeded with its charge to make a
report and recommendation to the Board on any needed
regulatory changes (whether statutory, rule-based,
training-based, or resource-based). That report and
recommendation is likely to be presented to the Board
this spring.
There continues to be discussion and debate at the
federal level about the need for amendments to the
federal Food, Drug, and Cosmetic Act to shift, clarify,
or both, the line between prescription drug compounding
(regulated at the state level by boards of pharmacy)
and prescription drug manufacturing (regulated at the
federal level by Food and Drug Administration (FDA)).
Board staff participated in an intergovernmental conference
hosted by FDA in late December 2012, where
multiple issues were discussed among federal and state
regulators. Indications are that federal legislation will
be introduced this spring. Board staff will update North
Carolina pharmacists on any developments.

Quoted from the North Carolina Board of Pharmacy April 2013 Newsletter