A drug that is issued to a correctional facility and has left the control of a pharmacist at a vendor pharmacy may be returned to its vendor pharmacy for the purpose of redispensing that drug to fill other prescriptions for other correctional facilities only if the following requirements are met:

(1) The drug is not a Schedule I, II, III, IV or V controlled substance as specified in the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act.

(2) The drug is returned to its vendor pharmacy in accordance with the vendor pharmacy's written policies and procedures that comply with section 1174 (relating to vendor pharmacy redispensing) and the State Board of Pharmacy's rules and regulations in regard to delivery, storage, labeling and reissuing of the drug.

(3) The drug is returned to the vendor pharmacy unopened and still sealed in the unit dose package, unit of issue package, bottle or manufacturer's package.

(4) Each returned unit dose package, unit of issue package, bottle or manufacturer's package retains the drug name, strength, manufacturer identifier, lot and expiration date as originally labeled by the pharmacy or manufacturer.

(5) The drug issued to the facility was at no time in the possession or control of a patient.

(6) The drug remained in a controlled environment of a secured drug room or secured drug cart under the supervision of designated personnel who are responsible for the drugs in that correctional facility.

(7) The drug has no fewer than 90 days before its expiration date.

(8) A pharmacist at the vendor pharmacy determines by visual inspection that the returned products are not adulterated or misbranded.

(9) A pharmacist at the vendor pharmacy using the pharmacist's professional judgment determines that:

(i) The conditions under which the drug has been delivered, stored and handled before and during its return to the pharmacy have preserved proper integrity, stability and labeling of the drug.

(ii) The drug labeling or packaging has not been altered or defaced.

(iii) The drug name, strength, manufacturer identifier, lot and expiration date are retrievable.

Cross References. Section 1173 is referred to in sections 1174, 1176 of this title.