IACP Update on S. 959

 IACP’s team of seven full-time Washington, D.C. lobbyists continue to find no evidence in their meetings with key Hill offices this morning that there will be a Senate vote this week on S. 959. All intelligence is indicating that a vote will come after the August recess. In the meantime, IACP’s Vice President of Government Affairs Sarah Dodge reports that IACP continues to work with several Senate offices who have reached out to IACP on amendment language to the bill, which also indicates that a vote is more likely after the recess. Please emailiacpinfo@iacprx.org if you have any questions on this information.

IACP Perspective: Why the Current Draft of S. 959 is Still Unworkable

• The compounding community has been collaborating with lawmakers and their staff on the development of legislation that will ensure we never have another NECC.
• The bill that has emerged from the Senate HELP Committee, Senate 959, will not protect patient safety and therefore IACP and the compounding community is not supporting it at this time.
• The bill exempts hospitals, health systems, and pharmacy benefit managers from the very protections it is putting in place, and we believe that these large exemptions will create safety gaps.  We believe that every patient should be assured of the same level of safety, whether they get their compounded medications from a pharmacy, a hospital, or a mail order pharmacy.  
• The bill also could interfere with patient access to compounded medications.  For instance, it prohibits the re-packaging of certain medications even when those re-packaged medications are far less costly.  It creates restrictions on anticipatory compounding and office use,  two methods for patients receiving medications when they need them.

Posted 7.30.13

From the FDA Blog--Dietary Supplements Containing Unsafe Food Additive Destroyed

In a victory for consumers, a Texas-based distributor of dietary supplements has destroyed its stock of two dietary supplements containing the stimulant dimethylamylamine (DMAA). 

In addition, a major distributor of the products – GNC Inc. - agreed to destroy the supplements in its possession after the Food and Drug Administration (FDA) obtained seizure orders for GNC facilities in three states. GNC has already destroyed its DMAA products in two of the three states, and we expect the products in the third state to be destroyed this week. 

The products – OxyElite Pro and Jack3D, distributed by USPlabs – had an estimated retail value of more than $8.5 million. Dietary supplements containing DMAA – an amphetamine derivative – are advertised as useful for losing weight, enhancing athletic performance and building muscle. Reports implicate DMAA in the narrowing of blood vessels and arteries, which can elevate blood pressure and lead to serious medical conditions, including heart attack, seizures, psychiatric disorders and even death. FDA has received reports of more than 100 illnesses associated with products containing DMAA, including six deaths. 

continue to read here

 

FDA Law Blog--Ricardo Carvajal, July 301, 2013 wrote Interesting piece entiled Might You Be An Imposter for Purposes of FSMA's FSVP REquirement? Now You Know

FDA Law Blog - Might You Be An “Importer” for Purposes of FSMA’s FSVP Requirement? Now You Know.

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Read here Might You Be An “Importer” for Purposes of FSMA’s FSVP Requirement? Now You Know.

Question of the Day July 30, 2013 Will the US Senate Be Successful in Using "unanimous Consent" to Pass Senate Bill 959, The Pharmaceutical Compounding Quality and Accountability Act.?

Unanimous Consent is a procedure prevents any debate, prohibits amendments, and no Senator is forced to go on the record and affirmatively support the bill.   The Senate Website does not currently have the bill listed for consideration next Monday but rumors are that is when it may be considered.  At least one U.S. Senator, Tom Colburn from Oklahoma, has indicated he will not agree to unanimous consent of the bill.  Stay tuned  to the blog for more information.

 

National Community Pharmacists Association, which claims the proposed legislation is anti-pharmacy

Pharmacists Group Lobbies Against Senate Compounding Bill

Yet another professional organization has found reason to object to the compounding bill moving through the US Senate. The latest group hoping to block its passage is the National Community Pharmacists Association, which claims the proposed legislation is anti-pharmacy and is relying on a parliamentary continue to read here