Md. Code Regs. 10.34.34.04

Current through Register Vol. 51, No. 24, December 2, 2024

Section 10.34.34.04 - Validated Pharmacy Technician

A. Validated Pharmacy Technician - Minimum Requirements.

(1) Experience. Prior to working as a validated pharmacy technician, an individual shall have a minimum of 1 year of experience as a registered pharmacy technician in the State.

(2) Training. In addition to the requirements for pharmacy technician registration, to act as a validated pharmacy technician, an individual shall possess a product verification certificate issued by a Board-approved national pharmacy technician certification program.

B. Validated Pharmacy Technician - Final Product Verification. A pharmacist may delegate responsibility to perform the final verification of a prescription device, drug product, or medication order to a validated pharmacy technician under the following circumstances:

(1) Prescription or Medication Order.

(a) A pharmacist shall verify the data entry of the prescription device, drug product, or medication order in the pharmacy management system or, if applicable, the electronic health record for:

(i) Accuracy;

(ii) Appropriateness of the device, drug product, or medication;

(iii) Appropriateness of the dosage form;

(iv) Directions for use;

(v) Labeling;

(vi) Packaging; and

(vii) Any other determination that requires the application of clinical expertise.

(b) Bar code scanning or similar technology is utilized during the filling process and at the verification step to validate device, drug product, or medication selection accuracy.

(c) The product being verified is packaged in unit-dose or unit-of-use packaging.

(2) Stocking or Replenishing a Medication Distribution System. Notwithstanding any other regulation, a validated pharmacy technician may perform the final product verification of a prescription device, drug product, or medication selected for stocking into a medication distribution system provided that:

(a) The medication distribution system utilizes bar code scanning or other similar technology to validate the device, drug product, or medication selection; and

(b) The pharmacy responsible for the medication distribution system maintains and reviews annually a quality assurance policy which includes routine audits of the system to ensure the accuracy of stocked prescriptions.

(3) A validated pharmacy technician may not perform the final product verification of a prescription device, drug product, or medication that the technician personally prepared.

C. Validated Pharmacy Technician - Pharmacy Permit Holder's Responsibilities. A pharmacy utilizing a validated pharmacy technician shall maintain records for a minimum of 2 years, and have those records readily available to the Board upon request, including:

(1) A current list of all validated pharmacy technicians;

(2) A job description for each validated pharmacy technician; and

(3) Policies and standard operating procedures for validated pharmacy technicians.

D. Validated Pharmacy Technician " Pharmacist's Responsibilities.

(1) A pharmacist may not delegate the final product verification of a compounded medication under any circumstance.

(2) Notwithstanding any delegation of a pharmacy act to a validated pharmacy technician, a pharmacist shall maintain professional responsibility for every medication or prescription dispensed, and for each medication or prescription stocked into a medication distribution system under the supervision of the pharmacist.

Md. Code Regs. 10.34.34.04

Regulations .04 amended effective 50:26 Md. R. 1132, eff. 1/8/2024