(b) Certification to return certain unused medications or drugs to the vendor pharmacy shall be permitted only under the following conditions:

1. (1) the facility employs a licensed health care professional; and
2. (2) access to drugs and biologicals is permitted only by authorized licensed health care professionals designated by the facility physician.

(c) An authorized licensed health care professional designated by the facility physician of a facility certified by the commission shall be permitted to return unused medications to the vendor pharmacy under the following conditions:

1. (1) a copy of the commission's certification permitting the return of medications is filed with the vendor pharmacy:

2. (2) all medication to be returned must be:

   1. (i) stored in accordance with section 7010.4 of this Part;
   2. (ii) sealed in unopened, individually packaged units; and
   3. (iii) within the recommended period of shelf life for the purpose of redispensing;

3. (3) drug products which may be returned are limited to:

   1. (i) oral and parenteral medication in single-dose hermetically sealed containers; and
   2. (ii) parenteral medication in multiple-dose hermetically sealed containers from which no doses have been withdrawn;
4. (4) the drug products returned show no obvious sign of deterioration;
5. (5) drug products packaged in manufacturer’s unit-dose packages may be returned for redispensing provided that they are redispensed in time for use before the expiration date, if any, indicated on the package;

6. (6) drug products repackaged by the pharmacy into unit-dose or multiple-dose “blister packs” may be returned to the pharmacy for redispensing provided that:

   1. (i) the date on which the drug product was repackaged, its lot number and expiration date are indicated clearly on the package;
   2. (ii) not more than 90 days have elapsed from the date of the repackaging;
   3. (iii) a repackaging log is maintained by the pharmacy in the case of drug products repackaged in advance of immediate needs;
7. (7) partially used “blister packs” may be redispensed only as returned to the pharmacy;
8. (8) partially used “blister packs” may not be emptied and repackaged;
9. (9) additional units of medication may not be added to partially used “blister packs;”
10. (10) no drug product dispensed in bulk in a dispensing container may be returned;
11. (11) no medication or drug product defined as a controlled substance in section 3306 of the Public Health Law may be returned; and
12. (12) no drug which is self-administered by an inmate, has been offered for delivery to an inmate, or has been in an inmate's possession may be returned.