PCCA response to:
“Frequently Asked Questions
S.959 – Pharmaceutical Quality, Security and Accountability Act” – Published July 24, 2013 by
proponents of Senate Bill 959
The FAQs are reproduced below in their entirety without alteration along with PCCA’s response.
Text in italics is a verbatim copy from the proponents of S.959’s FAQ.
Pharmaceutical Compounding Q & A – Title I of S.959
On May 22, 2013, the Committee on Health, Education, Labor and Pensions (HELP) approved S.959, the
Pharmaceutical Quality, Security and Accountability Act, by voice vote. In Committee, S. 959 was joined
with S.957, the pharmaceutical track and trace provisions. S.959 now contains two titles. Title I contains
the pharmaceutical compounding provisions, and Title II is drug tracing. Title I clarifies the regulation of
pharmacy compounding. Traditional pharmacy practice will continue to be regulated by the states, and
compounding manufacturers, which compound sterile products without a prescription and ship them
across state lines, will be overseen by the Food and Drug Administration (FDA). Compounding
manufacturers will be required to register and be inspected by the FDA.
PCCA RESPONSE
While Title I of S.959 attempts to clarify the regulation of pharmacy compounding, we feel that
the bill wanders greatly from its intended purpose. The statement “Traditional pharmacy
practice will continue to be regulated by the states,” is disingenuous as many new provisions
and regulations will squarely increase FDA’s role in the regulation of the “traditional” practice of
pharmacy. Also, the promulgation of a new category, called “compounding manufacturers”,
muddies the regulatory waters and places pharmacy practices across the United States in
impossible situations when trying to provide patient care. In the end, S.959 as it stands will
decrease patient access to compounded medications and negatively affect healthcare for
hundreds of thousands, if not millions, of patients.
How does the bill distinguish between pharmacy practice and manufacturing?
continue to read PCCA responses here
“Frequently Asked Questions
S.959 – Pharmaceutical Quality, Security and Accountability Act” – Published July 24, 2013 by
proponents of Senate Bill 959
The FAQs are reproduced below in their entirety without alteration along with PCCA’s response.
Text in italics is a verbatim copy from the proponents of S.959’s FAQ.
Pharmaceutical Compounding Q & A – Title I of S.959
On May 22, 2013, the Committee on Health, Education, Labor and Pensions (HELP) approved S.959, the
Pharmaceutical Quality, Security and Accountability Act, by voice vote. In Committee, S. 959 was joined
with S.957, the pharmaceutical track and trace provisions. S.959 now contains two titles. Title I contains
the pharmaceutical compounding provisions, and Title II is drug tracing. Title I clarifies the regulation of
pharmacy compounding. Traditional pharmacy practice will continue to be regulated by the states, and
compounding manufacturers, which compound sterile products without a prescription and ship them
across state lines, will be overseen by the Food and Drug Administration (FDA). Compounding
manufacturers will be required to register and be inspected by the FDA.
PCCA RESPONSE
While Title I of S.959 attempts to clarify the regulation of pharmacy compounding, we feel that
the bill wanders greatly from its intended purpose. The statement “Traditional pharmacy
practice will continue to be regulated by the states,” is disingenuous as many new provisions
and regulations will squarely increase FDA’s role in the regulation of the “traditional” practice of
pharmacy. Also, the promulgation of a new category, called “compounding manufacturers”,
muddies the regulatory waters and places pharmacy practices across the United States in
impossible situations when trying to provide patient care. In the end, S.959 as it stands will
decrease patient access to compounded medications and negatively affect healthcare for
hundreds of thousands, if not millions, of patients.
How does the bill distinguish between pharmacy practice and manufacturing?
continue to read PCCA responses here
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