Community pharmacy advocates have thrown their support behind a congressional plan to reform the nation’s pharmaceutical supply chain and impose tighter regulations on pharmacy compounding.


Drug Quality and Security Act, community pharmacy, pharmaceutical supply chain, pharmacy compounding, National Association of Chain Drug Stores, National Community Pharmacists Association, Healthcare Distribution Management Association, NACDS, NCPA, Steve Anderson, chain pharmacies, Food and Drug Administration, FDA, Douglas Hoey, compounded medications, New England Compounding Center, NECC












































































































































































































































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Industry groups back Rx legislation

October 14th, 2013

WASHINGTON – Community pharmacy advocates have thrown their support behind a congressional plan to reform the nation’s pharmaceutical supply chain and impose tighter regulations on pharmacy compounding.

The heads of the National Association of Chain Drug Stores, National Community Pharmacists Association and Healthcare Distribution Management Association all wrote letters to Senate and House of Representatives committee members late last month expressing their support for the proposal, saying it will help ensure the health and safety of patients across the country.

The law — the Drug Quality and Security Act — passed the House late last month and is pending in the Senate.

“We believe that the reforms contained within the legislation meet the overarching goal of protecting patients while allowing chain pharmacies to operate effectively and efficiently in dispensing needed medications,” NACDS president and chief executive officer Steve Anderson said in his letter to the leadership of the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce.

NACDS and the other associations note that the bill establishes one national standard for supply chain regulation as opposed to what they deem to be an unworkable patchwork of state laws and regulations.

“Chain pharmacy has made significant investments to ensure that the U.S. pharmaceutical distribution system is one of the safest in the world, and your legislation will only improve and strengthen the process for all stakeholders,” Anderson said.

In addition to its creating a uniform supply chain standard, the legislation calls for the creation of a system giving the Food and Drug Administration more authority to regulate companies that compound sterile drugs.

Under that provision, compounding pharmacies could voluntary place themselves under FDA regulation, giving the agency the authority to perform inspections.

“This compromise proposal provides a balanced and effective approach to address critical and complex issues surrounding compounded medications as well as strengthening our nation’s pharmaceutical supply chain,” NCPA CEO Douglas Hoey wrote in his letter.

Pharmacy advocates and lawmakers cite last year’s problems at the New England Compounding Center (NECC), in which more than 50 people died after an outbreak of fungal meningitis was traced back to drugs compounded there as clear evidence that the laws governing compounding and the pharmaceutical supply chain need to be overhauled.

 

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