Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Pharmacist's Manual - APPENDIX A-N

Appendix H

Guidelines for Emergency Kits in Long Term Care Facilities

A pharmacy may place an emergency kit with controlled substances in a non-DEA registered Long Term Care Facility (LTCF), if the appropriate state agency or regulatory authority specifically approves the placement and promulgates procedures that delineate:

  1. The source from which the LTCF may obtain controlled substances for emergency kits and that the source of supply is a DEA-registered hospital/clinic, pharmacy, or practitioner.
  2. The security safeguards for each emergency kit stored at the LTCF, including who may have access to the emergency kit, and specific limitation of the type and quantity of controlled substances permitted in the kit.
  3. The responsibility for proper control and accountability of the emergency kit within the LTCF, including the requirement that the LTCF and the supplying registrant maintain complete and accurate records of the controlled substances placed in the emergency kit, the disposition of the controlled substances, and the requirement to take and maintain periodic physical inventories.
  4. The emergency medical conditions under which the controlled substances may be administered to LTCF patients, including the requirement that controlled substances be administered by authorized personnel only as expressly authorized by an individual practitioner and in compliance with the provisions of 21 C.F.R. §§ 1306.11 and 1306.21.
  5. The prohibited activities that if violated could result in state revocation, denial, or suspension of the privilege to supply or possess emergency kits containing controlled substances.

The requirements for emergency kits in LTCFs were published in a Federal Register notice on April 9, 1980 (45 FR 24128). Pharmacies and LTCFs may wish to consult the notice to ensure compliance with the requirements.

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