Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Monday, November 18, 2013
NACDS Praises Senate Passage of Comprehensive Supply Chain and Compounding Legislation November 18, 2013
Urges prompt enactment and pledges continued vigilance during implementation
Arlington, Va. – The National Association of Chain Drug Stores (NACDS) praised the U.S. Senate’s passage of comprehensive supply chain and compounding legislation. The Drug Quality and Security Act (S. 3204) passed the Senate today by voice vote.
“The passage of this bill will help ensure the health and safety of patients,” said NACDS President and CEO Steven C. Anderson, IOM, CAE. “This is a large step in helping avoid tragedies such as last year’s national meningitis outbreak. At the same time, we appreciate the bill’s protection of traditional compounding practices largely performed by retail pharmacists.
“Chain pharmacy has made significant investments to ensure that the U.S. pharmaceutical distribution system is one of the safest in the world and this legislation will only improve and strengthen the process for all stakeholders.”
The bill establishes one national standard for supply chain regulation as opposed to an unworkable patchwork of state laws and regulations. In addition, the bill clarifies and creates an additional regulatory framework for sterile compounding to help safeguard patient safety.
NACDS previously expressed support for this legislation in a letter to congressional leaders stating, “[W]e believe [the agreement] will help guarantee patient safety through a more secure supply chain and appropriate and improved oversight of compounding activities. 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.”
“In addition to the champions in the House of Representatives including Chairman of the U.S. House Energy and Commerce Committee Fred Upton (R-MI) who helped to negotiate the legislation and advance it to approval in the House, we thank Chairman Tom Harkin (D-IA) and Ranking Member Lamar Alexander (R-TN) of the Senate Committee on Health, Education, Labor and Pensions for their leadership in moving this comprehensive bill through the Senate to final passage,” said Anderson. “We urge President Obama to move swiftly in signing this pro-patient legislation into law. NACDS also will remain highly engaged and vigilant as this issue moves to the always-important implementation phase.”