Section 2-33 - Automated Storage and Distribution Systems (a) Before using an automated storage and distribution system, a PIC shall ensure that the automated storage and distribution system and the policies and procedures comply with this chapter.
(b) The PIC shall establish policies and procedures for appropriate performance and use of the automated storage and distribution system that: - (i) Ensure that the automated storage and distribution system is in good working order while maintaining appropriate recordkeeping and security safeguards. This is to include the ability to store at the required temperature;
- (ii) Ensure that an automated storage and distribution system used by a pharmacy that allows access to drug or devices by a patient:
- (A) Only allows patient access to prescriptions that:
- (I) Do not require an offer to counsel by a pharmacist as specified in W.S. § 33-24-136(c);
- (II) Are properly labeled and verified by a pharmacist before placement into the automated storage and distribution system and subsequent release to patients; and
- (III) Are not a Schedule II controlled substance under the Wyoming Controlled Substances Act.
- (B) Allows a patient to choose whether or not to use the system;
- (C) Is located inside a building in a wall of a licensed pharmacy where the pharmacy staff has access to the device from within the pharmacy and patients have access from outside the pharmacy and is attached to the wall in such a manner that prevents unauthorized removal;
- (D) Provides a method to identify the patient and only release the identified patient's prescriptions;
- (E) Is secure from access and removal of drugs or devices by unauthorized individuals;
- (F) Provides a method for a patient to obtain consultation with a pharmacist, if requested by the patient; and
- (G) Prevents dispensing of refilled prescriptions, if a pharmacist determines that the patient requires counseling.
- (iii) Ensure that an automated storage and distribution system used by a pharmacy that allows access to drugs or devices for the purposes of administration only by authorized licensed personnel based on a valid prescription order or medication order.
- (A) Provides for adequate security to prevent unauthorized individuals from accessing or obtaining drugs or devices; and
- (B) Ensures the filling, stocking or restocking of all drugs or devices in the system may be done only by a pharmacist, pharmacy intern or pharmacy technician.
- (iv) Implement an ongoing quality assurance program that monitors compliance with the established policies and procedures of the automated storage and distribution system and federal and state law.
(c) The PIC shall: - (i) Ensure the policies and procedures for the performance and use of an automated storage and distribution system are prepared, implemented and complied with;
- (ii) Review and document annually and, if necessary, revise the policies and procedures required under this Section; and
- (iii) Make the policies and procedures available for employee reference and inspection by the Board within the pharmacy and at any location outside the pharmacy where the automated storage and distribution system is used.
(d) The Board may prohibit a PIC from using an automated storage and distribution system if the pharmacy licensee or the pharmacy licensee's employees do not comply with the requirements of this Section.
059-2 Wyo. Code R. § 2-33
Amended, Eff. 10/31/2017.