AMCP Responds to Senate Approval of Drug Quality & Security Act

AMCP shares desire to prevent another 'New England Compounding Center' compounding tragedy, but believes H.R. 3204's voluntary registration will not protect the public 

For Immediate Release

Alexandria, Va., November 20, 2013 — The Academy of Managed Care Pharmacy (AMCP) Pharmacy today released the following statement by CEO Edith A. Rosato, RPh, IOM, in response to Senate passage of the Drug Quality and Security Act (HR 3204), a bill that would enhance the security of drug distribution and create a new entity in statute ("outsourcing facility) for the compounding of drugs:
"The Academy of Managed Care Pharmacy strongly supports the goal of establishing national standards to protect the drug distribution supply chain. AMCP has consistently worked to support legislation that fosters more security in the drug supply chain – protecting patient safety is paramount to our members." 
"AMCP shares the public's and Congress's desire to prevent another tragedy like the one last year involving New England Compounding Center. Nevertheless, we're very concerned that the bill's voluntary registration scheme will not achieve the main goal – to protect the public from the unauthorized compounding of drugs. Simply put, the "outsourcing facility" created under the bill will not be required to register with the FDA. With the bill's limited scope, only those facilities that volunteer to register will be subject to the FDA, which will leave the public no better off. Facilities that compound drugs, are not licensed pharmacies and choose not to register with the FDA will continue to "escape" regulation and oversight." 
"AMCP is also concerned about another regulatory wrinkle in the bill. A licensed pharmacy, which is already regulated by state pharmacy boards, that registers as an "outsourcing facility" will then be subject to FDA regulation. We believe this dual regulatory scheme will lead to administration and regulatory confusion, creating opportunities for gaps in responsibility and accountability." 
The bill now heads to the president's desk for signature. To read AMCP's letter to Congress dated Oct. 8, 2013 click here.
About AMCP  
The Academy of Managed Care Pharmacy is a national professional association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to improve health care for all. The Academy's nearly 7,000 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit. It is celebrating its 25th anniversary in 2013. More news and information about the Academy can be found at 
For more information, please contact:
Kevin Bruns | 703-683-8416 ext. 656