2020-21675: Registering Emergency Medical Services Agencies Under the Protecting Patient Access to Emergency Medications Act of 2017

Summary

The "Protecting Patient Access to Emergency Medications Act of 2017," (hereafter the "Act") which became law on November 17, 2017, amended the Controlled Substances Act to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances. In addition, the Act allows emergency medical services professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional pursuant to a valid standing or verbal order. The Drug Enforcement Administration proposes to amend its regulations to make them consistent with the Act and to otherwise implement its requirements.

The agency’s own summary, as published.

What this changes

Amends 5 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 1300 Definitions
• 21 CFR 1301 Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
• 21 CFR 1304 Records and Reports of Registrants
• 21 CFR 1306 Prescriptions
• 21 CFR 1307 Miscellaneous