1. A. The director of pharmacy shall establish and operate under a policies and procedures manual which:

   1. (1) Complies with this chapter;
   2. (2) Defines the scope and method of pharmacy services provided to the patients of the institutional facility;
   3. (3) Determines when personnel may have access to the pharmacy area;
   4. (4) Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle;

   5. (5) Includes:

      1. (a) Labeling requirements that meet the requirements of this chapter;
      2. (b) Distribution methods for medication that assures that a patient receives the correct dose ordered by the prescriber;
      3. (c) Packaging methods that assure the medication is appropriately identified, designed to maintain stability until expiration and traceable throughout the distribution chain to facilitate recall;
      4. (d) Distribution methods that provide for safe handling of medications that may be manual or computerized employing centralized, decentralized, or remote devices that meet the requirements of COMAR 10.34.28.
      5. (e) Pharmacy security methods that comply with this chapter;
      6. (f) Conditions in which an emergency drug supply may be replenished or prepared, delivered, and stored by the institutional facility;
      7. (g) Duties that may be performed by a licensed pharmacist, registered pharmacy technician and unlicensed personnel; and
      8. (h) Methods for proper disposal of pharmaceuticals as required by State and federal law;

   6. (6) Is provided to:

      1. (a) The personnel of the pharmacy;
      2. (b) The institutional facility; and
      3. (c) Upon request, an agent of the Board; and

   7. (7) Is in a form that is:

      1. (a) Written or electronic; and
      2. (b) Readily retrievable;
2. B. The director of pharmacy shall provide annual training on the policies and procedures manual to the personnel of the pharmacy.

Authority: Health Occupations Article, §12-205, Annotated Code of Maryland

Effective date: November 6, 1995 (22:22 Md. R. 1666)

Chapter revised effective October 1, 2011 (38:19 Md. R. 1147)

Regulation .02B amended effective May 31, 2014 (40:19 Md. R. 1547)

Regulation .03 amended effective May 31, 2014 (40:19 Md. R. 1547)

Regulation .06C amended effective May 31, 2014 (40:19 Md. R. 1547)

Regulation .12B amended effective May 31, 2014 (40:19 Md. R. 1547)

Regulation .17 adopted effective May 31, 2014 (40:19 Md. R. 1547)