SEPTEMBER 28, 2013 BY PROTECT MY COMPOUNDS
September 27, 2013
A bipartisan, bicameral agreement on compounding has been linked to the track-and-trace bill, known as the “Drug Quality and Security Act” (HR 3204). Leaders from the House Energy & Commerce Committee and Senate Health, Education, Labor & Pensions Committee made the announcement September 25, and released bill language late that night. Revisions to the bill were made the following day. Proponents in the House are trying to pass the bill under “suspension of the rules”, meaning they need two-thirds of the House to support the track and trace/compounding compromise. We expect this could happen as soon as tomorrow, Saturday September 28.
In conversations with key legislators, PCCA was able to get clarification in the bill which allows compounding pharmacies to elect to become “outsourcing facilities” on a voluntary basis. This is an important change as the first draft of the bill was ambiguous on this point. With the voluntary election provision, the bill paints a clear picture as to why a pharmacy may elect to become an outsourcing facility and, more importantly, shows that the FDA cannot force a pharmacy to become an outsourcing facility because of some arbitrary rule the FDA would feel it could enforce.
There are some additional improvements made to this bill over the Senate Bill 959. HR 3204 does not provide exemptions for certain types of pharmacy practice nor does it require pharmacies practicing under 503(A) to report their compound activities to the FDA when compounding for drug shortages. PCCA would have hoped for additional revisions to 503(A) to modernize a fifteen year old piece of legislation to reflect the current state of pharmacy compounding. If the current legislation is signed into law, we will continue discussions with our legislators about this issue.
After carefully reviewing the legislative options, we believe the bill could still have unintended consequences, however, we also believe opposing or delaying the bill would give other interests the opportunity to negatively influence the bill even further. Therefore, PCCA has decided to be neutral regarding the “Drug Quality and Security Act”.
PCCA is committed to remaining an active participant in legislative issues and continue to represent our members and their patients to ensure access to compounded medications.
Sincerely,
Dave Sparks
CEO
PCCA
CEO
PCCA