(1) In an institutional facility that does not have an in-house pharmacy or 24-hour access to dispensing services, medications may be provided for use by authorized personnel through contingency kits, prepared by the registered pharmacist, providing pharmaceutical services to the facility. Such contingency kits must meet all of the following requirements:
(a) the supplying or consultant pharmacist and director of nursing shall designate nursing personnel who may obtain access to the drug supply;
(b) the supplying or consultant pharmacist and the designated practitioner or appropriate committee of the institutional facility shall jointly determine the contents and quantity of drugs to be included in the kit;
(c) the kit must be locked and stored in a secure area to prevent unauthorized access and to ensure a proper storage environment for the drugs contained therein;
(d) the supplying pharmacist and director of nursing will provide adequate controls to prevent drug diversion;
(e) medications in the kit must be prepackaged and properly labeled, including lot number and expiration date, and shall possess any additional information that may be required to prevent risk of harm to the patient; and
(f) the exterior of the kit must be clearly labeled to indicate:
(i) its contents and expiration date; and
(ii) the name, address, and telephone number of the supplying pharmacy.
(2) Drugs shall be removed from kits only:
(a) by the supplying pharmacist; or
(b) by authorized nursing personnel pursuant to a valid drug order and reviewed by a pharmacist; or
(c) during inspection of the kit.
(3) Removal of any drug from the contingency kit by authorized nursing or pharmacy personnel must be recorded on a suitable form showing the following information:
(a) patient name;
(b) name, strength, and quantity of drug removed;
(c) date and time the drug was removed; and
(d) signature of the authorized personnel removing the drug.
(4) The supplying pharmacist shall ensure that:
(a) written policies and procedures are established to implement the requirements of this rule;
(b) all drugs are properly labeled;
(c) only prepackaged drugs are available in amounts sufficient for short-term therapeutic requirements to meet the needs of the facility when dispensing pharmacy services are unavailable;
(d) replacement of medications is performed in a timely manner by authorized personnel;
(e) at a minimum, the kit shall be inspected annually; and
(f) at least one copy of the documentation for all drugs that have been removed from the contingency kit shall be kept at the long-term care facility and one copy at the supplying pharmacy.
(5) The expiration date of a kit must be the earliest date of expiration of any drug supplied in the kit. On or before the expiration date, the supplying pharmacist shall replace the expired drug.
(6) The contents of the contingency kit and all related records shall be made freely available and open for inspection to representatives of the board and when information of possible violations is received.