Md. Code Regs. 10.32.23.10

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.32.23.10 - Records

A. A permit holder shall keep readily retrievable at each dispensing location:

(1) A copy of the dispensing permit issued by the Board;

(2) A record of each final check;

(3) A copy of the form, signed and dated by the patient, maintained in accordance with COMAR 10.13.01.04, indicating the patient's determination that a pharmacy is not conveniently available and demonstrating that the determination was made solely by the patient;

(4) The delegation agreement of any physician assistant for whom the permit holder dispenses prescription drugs at that location, including the name of the primary supervising physician and any alternate supervising physician;

(5) A list of the name and license number of all physician assistants for whom the permit holder dispenses drugs at that location;

(6) A list of the name, license number, and specialty of all certified registered nurse practitioners for whom the permit holder dispenses drugs at that location;

(7) The permit holder's protocols for handling drug recalls, including the arrangements for notifying patients;

(8) The permit holder's protocols for disposal of drugs;

(9) With respect to suppliers from whom the permit holder purchased prescription drugs:

(a) The name, address, and phone number of each supplier; and

(b) Documentation including:

(i) For any pharmacy supplier, the number and the expiration date of the pharmacy permit issued by the Maryland Board of Pharmacy and the number and expiration date of the CDS registration issued by OCSA; and

(ii) For each wholesale supplier, the number and the expiration date of the distribution permit issued by the Maryland Board of Pharmacy and the number and expiration date of the CDS registration issued by OCSA; and

(10) Any other purchasing, inventory, and dispensing records required by State or federal statutes or regulations.

B. In addition to meeting the requirements of Regulation .10A, the permit holder shall comply with any other State or federal law or regulation relating to dispensing of prescription drugs.

C. A permit holder who dispenses CDS shall keep additional records available for inspection as required by COMAR 10.19.03.05.

Md. Code Regs. 10.32.23.10

Regulation .10 adopted effective 45:6 Md. R. 320, eff. 3/26/2018