Wednesday, May 8, 2013

NCPA Submits Comments to Senate HELP Committee Draft Compounding Proposal:

On April 26, 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee
released a draft proposal on pharmaceutical compounding and requested stakeholder
comments. Chairman Harkin, Ranking Member Alexander, and Senators Franken, Roberts,
Bennet, Burr, Enzi, Hatch, Isakson, Mikulski, Warren, and Whitehouse formed the working
group on the HELP Committee to produce the draft and all members on this working group
are said to support the draft proposal in its current form. The draft proposal as well as a
section-by-section summary can be found at
Following review by the NCPA Compounding Committee, NCPA submitted formal
comments to the HELP Committee detailing NCPA’s concerns with the draft compounding
proposal. NCPA stated its support for committee efforts to preserve authority of state
Boards of Pharmacy over pharmaceutical compounding; prohibit FDA access to
compounding pharmacies’ records; increase state and Federal communication; and
conduct a GAO study analyzing impact on patient access to compounded medications.
NCPA also expressed strong concerns for the draft proposal’s use of categories other than
“compounding” and “manufacturing;” language that creates an “automatic trigger” to
identify a pharmacy that is “pooling sterile drugs” as a manufacturer; exemption for
pharmacies within health systems from proposed compounding requirements;
authorization for FDA to develop do not compound lists for drugs, categories of drugs, and
bulk substances; requirement for prescriber “notation” in order to compound “variations”
of marketed drugs; and requirement to notify the Secretary before compounding copies of
marketed FDA-approved drugs in times of drug shortages.
This is the first step in a long process. The Senate HELP Committee is expected to host a
compounding hearing on Thursday, May 9th at 10am followed by a markup hearing before
Memorial Day weekend. While these dates could be pushed back, that is the timeframe
currently. The House is taking a much different approach and has not released any draft
legislation to be reviewed at this time. NCPA continues to monitor this issue, regularly
discuss concerns with House and Senate pertinent committees, and our members, and act
as a resource to all Congressional staff as they move forward with any draft proposals.
NCPA will continue to keep all members apprised of any movements on this important

Source quoted from here

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