Md. Code Regs. 10.34.04.08

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

Section 10.34.04.08 - Preparation of Stock and Investigational Medications

A. A pharmacist may provide medication for use as stock medication for a licensed health care facility in accordance with applicable laws, if the pharmacy providing the medication also serves as the primary provider of patient specific medication for the facility.

B. A pharmacist may provide medication for use as stock medication for final dispensing or administration by an authorized prescriber who is permitted by law to administer or dispense medication if the pharmacist receives a written stock medication order from the authorized prescriber for each delivery of medication to the authorized prescriber.

C. A pharmacist may prepare, package, and label investigational drugs not destined for a specific individual at the time of preparation, packaging, and labeling if:

(1) The study for which medications are prepared, packaged, and labeled is approved by an institutional review board as defined in federal law; and

(2) The pharmacy permit holder ensures that records disclosing the identity of the subject who eventually receives the medication are:

(a) Received by a pharmacist on duty at the pharmacy within 30 days after being provided to a patient; and

(b) Maintained in the pharmacy.

Md. Code Regs. 10.34.04.08

Regulation .08 Transfer and Outsourcing of Prescriptions and Prescription Orders adopted effective June 25, 2001 (28:12 Md. R. 1110)