Federal Programs

U.S. House Passage of Drug Quality and Security Act

On September 28, the U.S. House of Representatives passed the Drug Quality and Security Act. This legislation addresses pharmaceutical compounding and the prescription drug supply chain and would:

• Distinguish compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions.
• Define the Food and Drug Administration’s role in oversight of outsourcing facilities.
• Offer providers and patients more information about compounded drugs.
• Clarify current federal law regarding pharmacy compounding.
• Develop a workable pathway to unit-level tracking.
• Strengthen licensure requirements for wholesale distributors and third-party logistics providers.
• Establish nationwide drug serial numbers.

Full Bill Text

Some of the national associations have distributed additional information regarding this Act; briefs and links to the information are provided below. Our thanks to the Missouri Pharmacy Association for compiling them and making them available to our membership.

• National Community Pharmacists Association (NCPA)
  NCPA’s Analysis of the Drug Quality and Security ActThis analysis is specific to Title I of the Act, which addresses pharmaceutical compounding of human drugs and provides a myth and fact sheet. View full text [[https://www.ncpanet.org/index.php?option=com_user&view=login&return=aHR0cHM6Ly93d3cubmNwYW5ldC5vcmcvaW5kZXgucGhwL21lbWJlcnNoaXAvbWVtYmVycy1vbmx5]]. (This information is limited to NCPA members only, and login is required to access the document.)
• National Association of Chain Drug Stores (NACDS)
  NACDS Expresses Support for Congressional Agreement on Comprehensive Supply Chain and Compounding Legislation
  
  NACDS endorses the act and states the legislation will make strong efforts to ensure the health and safety of the American public. They specifically note that the act establishes one national standard for supply chain regulation as opposed to an unworkable patchwork of state laws and regulations. View full text.
• International Academy of Compounding Pharmacists (IACP)
  HR 3204 the Drug Quality and Security Act: What Does It Say? What Does It Mean? What Happens Now?IACP breaks down the compounding section of this Act and highlights several sections that raise concern for them. View full text.
• Professional Compounding Centers of America (PCCA)
  PCCA Response to HR 3204PCCA believes the bill could have unintended consequences; however, they also believe opposing or delaying the bill would give other interests the opportunity to negatively influence the bill even further. Therefore, PCCA has decided to be neutral regarding the Drug Quality and Security Act. View full text.

The bill will now go over to the Senate for consideration and a vote at some point in the future. TPA will keep members informed regarding the status of this bill.