D.C. Mun. Regs. tit. 22, r. 22-B1920

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B1920 - PHARMACIST-IN-CHARGE

1920.1

A retail/community pharmacy, special or limited use pharmacy, or non-resident pharmacy shall be managed by a pharmacist (hereafter referred to as "Pharmacist-in-charge"). The pharmacist-in-charge shall be licensed to practice pharmacy in the District of Columbia, except that the pharmacist-in-charge of a non-resident pharmacy shall be licensed in the state in which the pharmacy is located.

1920.2

A pharmacist may not serve as a pharmacist-in-charge unless he is physically present in the pharmacy a sufficient amount of time to provide supervision and control. A pharmacist may not serve as a pharmacist-in-charge for more than one (1) pharmacy at a time except upon obtaining written permission from the Director.

1920.3

In addition to any other responsibilities set forth under this Title, the pharmacist-in-charge or proprietor of a pharmacy shall have the following responsibilities:

(a) Ensuring that quality assurance programs are in place for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems. Quality assurance programs shall be designed to prevent and detect drug diversion;

(b) Developing or adopting, implementing, and maintaining a training manual and program for the training of all individuals employed in the pharmacy who are legally authorized to assist in the practice of pharmacy. The pharmacist-in-charge shall be responsible for supervising the training program;

(c) Developing or ensuring the establishment of policies and procedures for the procurement, storage, security, and disposition of drugs and devices;

(d) Developing or ensuring the establishment of policies and procedures for the provision of pharmacy services;

(e) Ensuring that the automated pharmacy system is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate recordkeeping and security safeguards;

(f) Implementing an ongoing quality assurance program that monitors performance of the automated pharmacy system, which is evidenced by written policies and procedures;

(g) Ensuring that all pharmacists employed at the pharmacy are currently licensed in the District of Columbia, or if it is a non-resident pharmacy, in the state in which the pharmacy is located;

(h) Ensuring that all pharmacy interns employed at the pharmacy are currently registered in the District of Columbia;

(i) Ensuring the making or filing any reports required by federal or District of Columbia laws or regulations, which shall include but not be limited to, notifying the Director of the occurrence of any of the following:

(1) Permanent closing;

(2) Change of proprietorship, management, location, or pharmacist-in-charge;

(3) Any theft or loss of prescription drugs or medical devices;

(4) Conviction of any employee of any federal, state, or District of Columbia drug laws;

(5) Disasters, accidents, or any theft, destruction, or loss of records required to be maintained by federal or District of Columbia law or regulation;

(6) Occurrences of significant adverse drug reactions;

(7) Illegal use or disclosure of protected patient health information;

(j) Developing or ensuring the establishment of policies and procedures for preventing the illegal use or disclosure of protected health information, or verifying the existences thereof and ensuring that all employees of the pharmacy read, sign, and comply with the established polices and procedures; and

(k) Developing or ensuring the establishment of a procedure for proper management of drug recalls which may include, where appropriate, contacting patients to whom the recalled drug product(s) have been dispensed.

1920.4

The pharmacist-in-charge may be assisted by a sufficient number of pharmacists, pharmacy interns, and pharmacy technicians as may be required to competently and safely provide pharmacy services.

1920.5

The pharmacist-in-charge or proprietor of a pharmacy shall assure the development and implementation of written policies and procedures to specify the duties to be performed by pharmacy interns and pharmacy technicians. The duties and responsibilities of these personnel shall be consistent with their training and experience. These policies and procedures shall, at a minimum:

(a) Specify that pharmacy interns and pharmacy technicians are to be personally and directly supervised by a pharmacist stationed within the same work area who has the ability to control and who is responsible for the activities of the pharmacy interns and pharmacy technicians; and

(b) Specify that pharmacy interns and pharmacy technicians shall not be assigned duties that may be performed only by a pharmacist, which shall include but not be limited to:

(1) Drug utilization review;

(2) Clinical conflict resolution;

(3) Prescriber contact concerning prescription drug order clarification;

(4) Patient counseling on prescription, over-the-counter, and herbal products;

(5) Dispensing process validation;

(6) Receiving new oral prescription drug orders, or refill authorizations;

(7) Prescription transfers; and

(8) Independent compounding.

D.C. Mun. Regs. tit. 22, r. 22-B1920

Final Rulemaking published at 38 DCR 6734, 6752 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008)