Compounding Legislation: Your Voice Urgently Needed Now! - July 30, 2013

It’s hard to believe that after the many deaths and illnesses associated with the alleged practices at the New England Compounding Center last Fall, the bipartisan Senate bill (S.959) that is designed to prevent a tragic repeat could be facing tremendous opposition.

ASHP strongly supports this legislation. Yet, it appears that opposition to the Senate bill is forming, because certain interests want to protect the status quo, which we believe could be at the expense of protecting patients from another compounding tragedy.

These special interests are also threatening to severely limit how pharmacists in hospitals and health systems serve and protect patients. ASHP supports the provision in the bill that exempts health systems from being designated as compounding manufacturers. Without this important exemption, many hospitals and health systems would have to register with the Food and Drug Administration (FDA) as compounding manufacturers, since anticipatory compounding is required for us to meet the needs of our sickest and most vulnerable patients.  Also, without the exemption, many hospitals would not be able to prepare compounded preparations and send them to their wholly owned outpatient clinics, surgery centers, smaller inpatient facilities, and medical office practices.   This is a critical distinction, based on the fact that hospitals and health systems are fully accountable for the comprehensive care of the patient – as compared to a compounding manufacturer that sells its products across state lines without a prescription or knowledge of the patient to a third party for administration.

This distinction between health systems and compounding manufacturers is based on very important differences:

• Hospitals and health systems have well-established quality improvement, infection control, and risk management committees, as well as adverse event monitoring and reporting systems.

• Health systems must comply with the Centers for Medicare & Medicaid Services (CMS) Hospital Conditions of Participation and are accredited by quality improvement organizations such as The Joint Commission and DNV Healthcare, both of whom have deemed status with CMS.

• Hospitals and health systems have Pharmacy and Therapeutics Committees that control approved drug formularies.

We must protect the important work that pharmacists do in hospitals and health systems to take care of their patients.  In addition, hospital pharmacists and other providers must be assured that when they need to purchase compounded products from outside suppliers that they can expect to receive products that are safe and effective for their patients.  Therefore, we must enact into law urgently needed regulatory control over compounding manufacturers to prevent another tragedy.

You can make a difference. Your voice really matters to your elected Senators and Representatives in Congress!

ASHP has made it as easy as just a few clicks on your computer for your voice to be heard.

Go to ASHP’s advocacy page and make a difference for patient safety!

Tell your Senators that you want them to vote “YES” in support of S. 959.  This legislation creates a new category, “compounding manufacturer,” which will be regulated by the FDA. Hospitals and health systems are considered traditional compounders in the legislation and will remain under the purview of state boards of pharmacy and other accrediting bodies.

Tell your Representative that the House should take a similar approach to the legislation and give the FDA the tools it needs to prevent another tragedy.

Your support today can go a long way in getting this important legislation passed!

- See more at: http://www.ashpintersections.org/2013/07/compounding-legislation-your-voice-urgently-needed-now/#sthash.JPRzl7wj.dpuf

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.