Compounding

THE PROBLEM
For many decades independent community pharmacists have provided millions of adults, children, and pets with access to safe, effective, and affordable medications through compounding services. When manufactured drugs aren’t an option, independent community pharmacists provide traditional pharmacy compounding to prepare customized medications for patients. The FDA, however, is implementing the Drug Quality and Security Act (DQSA) in ways that are in stark contrast to Congressional intent, which is hindering patient access.

THE SOLUTION: Preserve patient access to compounded medications.
The Preserving Patient Access to Compounded Medications Act, H.R. 2871, will clarify the Drug Quality and Security Act, or DQSA, in a way that will better align the statute with congressional intent and balance public safety with patient access.

H.R. 2871 WILL ...

  • Allow pharmacists to compound medications for prescribers to administer to their patients where authorized by state law.

  • Prevent FDA regulatory authority over interstate "dispensing" of compounded medications. This leaves the regulatory authority to state laws and state boards of pharmacy.

  • Preserve the role of state boards of pharmacy in conducting pharmacy inspections.

  • Require FDA to follow formal rulemaking procedures. Currently, FDA is issuing "guidance documents" that they are enforcing through warning letters without following formal rulemaking procedures. This bill would allow stakeholder input and decrease confusion by providing formal FDA procedure and statements on the record.

TAKE ACTION

Visit our Legislative Action Center to send a letter to your elected officials.

USP <800>
U.S. Pharmacopeia, or USP, recently created chapter <800> to guide the handling of hazardous drug in health care settings. This chapter eliminates the hazardous drug low volume clause in USP <797> in which sterile compounding of hazardous drugs in low volume would not require negative pressure. Because this has a direct impact on many of our compounding pharmacies, we have collected several resources to help you understand and adjust to USP <800>.

USP <800> Frequently Asked Questions
USP Compounding Compendium
USP Healthcare Quality & Safety Newsletter
Self-Assessment of Safe Handling Practices for Hazardous
Drugs

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