64B16-28.301. Destruction of Controlled Substances - Institutional Class I Pharmacies (Nursing Homes)

(1) Controlled substances that have been dispensed and not used by the patient shall not be returned to the pharmacy and shall be securely stored by the nursing home until destroyed.

(2) For each controlled substance destroyed, documentation must be completed showing the name and quantity of the drug, strength and dosage form, patient’s name, prescription number and name of the institution. Destruction of the controlled substance shall be witnessed by at least two (2) of the following individuals:

(a) Consultant pharmacist;

(b) Director of nursing

(c) Facility administrator;

(d) A licensed physician, mid-level practitioner, nurse, or another pharmacist employed by or under contract or written agreement with the facility, or

(e) A sworn law enforcement officer.

Those individuals witnessing the destruction of the controlled substance shall sign the completed documentation.

(3) The consultant pharmacist shall be responsible for the creation and implementation of policies and procedures to ensure that controlled substances are disposed of in accordance with applicable state and federal laws and rules. Furthermore, the consultant pharmacist shall review all controlled substance destruction documentation monthly to ensure compliance with this rule and federal and state law.

(4) The consultant pharmacist shall ensure that non-controlled substances are returned to the provider pharmacy in compliance with Rule 64B16-28.118, F.A.C.

Rulemaking Authority 465.005, 465.022(12) FS. Law Implemented 465.022(12), 465.019, 893.07(1), (3), (5) FS. History–New 4-21-87, Formerly 21S-19.001, Amended 7-31-91, Formerly 21S-28.301, 61F10-28.301, Amended 1-30-96, Formerly 59X-28.301, Amended 7-21-09, 2-10-14, 11-5-17.