59A-26.012. Drugs and Pharmaceutical Services

(1) An ICF/DD must have a Class I Institutional Pharmacy Permit as required by the Department of Health in Section 465.019, F.S. All prescription medications must be compounded and dispensed by a pharmacy registered in Florida. A consultant pharmacist must be responsible for implementation of the pharmacy program as defined by each licensee even when the consultant pharmacist is not the vendoring pharmacist.

(2) Labeling of prescription medications must be done as required by the Department of Health in Sections 465.0235, 465.186 and 499.0054, F.S. and Rule Chapter 64B16-27, F.A.C., as required by the Department of Health.  Stock bottles of nonprescription drugs which are properly labeled according to the regulations related to the Drug and Cosmetic Act, Section 499.0054, F.S., are permitted.

(3) All drugs, including nonprescription stock drugs, must be stored in a locked room or cabinet, or in a locked drug cart. External medications must be stored separately from internal and ophthalmic preparations.

(4) Biologicals and other drugs must be stored to maintain its integrity of packaging, quality and potency. If refrigeration is required then these drugs must be in a locked container.

(5) All drugs listed in Schedules II through V must be handled, used, administered and dispensed as required by the Florida Comprehensive Drug Abuse Prevention and Control Act in Section 893.06, F.S.

(6) A count of controlled drugs listed in Schedules II-V of Section 893.03, F.S., must be made jointly between shifts by the licensed nurse beginning duty and the licensed nurse leaving duty. For facilities licensed for six beds or less, the count must be done by the supervising registered nurse on a weekly basis. For facilities licensed for more than six beds, a medication count of controlled substances must be made at every change of shift by the licensed nurse or an unlicensed medication assistant (UMA) as defined in Rule 59A-26.002, F.A.C. The count at shift change must be witnessed by another licensed nurse or another staff member trained in medication administration.

(7) A record must be maintained for all drugs listed in Section 893.03, F.S., of the Florida Comprehensive Drug Abuse Prevention and Control Act as Schedules II, III, IV, and V for continuous reconciliation.

(8) Medicinal substances classified as controlled substances by the Drug Enforcement Administration (DEA), as provided in the Drug Abuse Prevention and Control Act of 1970 and related regulations, and Section 893.03, F.S., as required by the Florida Comprehensive Drug Abuse Prevention and Control Act and must be disposed of as required by Rule 64B16-28.303, F.A.C., as required by the Department of Health.

(9) Disposal of other drugs not covered above must be made in accordance with a system of drug administration.

(10) All prescribed drugs dispensed for the client while in the facility may be given to the client or client’s representative upon discharge with the physician’s written orders.

(11) An inventory of drugs released must be prepared and signed by the licensed nurse releasing the drugs and the person receiving the drugs. This inventory must be filed in the client’s medical record.

(a) All medications of deceased clients must be accounted for on an inventory list prepared by a licensed nurse and filed in the client’s record. These medications must be returned for credit or destroyed in accordance with subsections (8) and (9) above.

(b) All controlled drugs not administered to a client due to wastage, loss, or returned to the pharmacy must be documented in each client’s medical record and accounted for by licensed nurse as required by the Florida Comprehensive Drug Abuse Prevention and Control Act in Section 893.07, F.S.

(12) All verbal orders must be written on the physician’s order sheet by the licensed nurse receiving the order and countersigned by the physician within 72 hours. Verbal orders for Schedule II drugs are permitted in emergency situations but are limited to a 72-hour supply. In an emergency situation, the physician must directly contact the pharmacist and the pharmacist must receive a copy of the original or direct copy of the physician’s order within 72 hours as required by the Florida Comprehensive Drug Abuse Prevention and Control Act in Section 893.04, F.S.

(13) Telephoned physician orders for medication may only be accepted by a licensed nurse, a physician’s assistant or a licensed pharmacist. Telephoned orders will be immediately recorded in the client’s medical record. Faxed physician orders are acceptable with a physician’s signature. A physician’s signature on the original physician’s order must occur within 72 hours of receipt of the faxed order.

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2)(f) FS. History–New 12-21-15.