Md. Code Regs. 10.34.33.06-1

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

Section 10.34.33.06-1 - Repositories Participating in the Donation Program

A. Designated Pharmacist. A repository in the donation program shall designate a pharmacist who shall:

(1) Accept donated prescription drugs or medical supplies forwarded by:

(a) A drop-off site; or

(b) A manufacturer regulated by the U.S. Food and Drug Administration;

(2) Inspect donated prescription drugs or medical supplies;

(3) Accept donated prescription drugs or medical supplies that meet the requirements of Regulations .02 and .03 of this chapter; and

(4) Obliterate from the labels of donated prescription drugs or medical supplies patient specific information for which the donated prescription drugs or medical supplies were originally dispensed when it is placed in inventory.

B. Record Requirements. A repository in the Donation Program shall:

(1) Maintain a separate inventory of donated prescription drugs or medical supplies for a minimum of 5 years;

(2) Maintain separate prescription files for patients receiving donated prescription drugs or medical supplies for a minimum of 5 years; and

(3) Submit an annual report on its activities to the Board that includes at least information on the:

(a) Number of recipients by county;

(b) Approximate market value of the prescription drugs or medical supplies dispensed;

(c) 50 prescription drugs or medical supplies most frequently dispensed; and

(d) Total number of donations to the Program.

C. Procedures for Handling of Donated Prescription Drugs or Medical Supplies.

(1) A repository in the Donation Program shall store donated prescription drugs or medical supplies in a secure location separate from other inventory in accordance with State and federal laws and regulations.

(2) A repository may not:

(a) Resell prescription drugs or medical supplies donated to the Program; or

(b) Establish or maintain a waiting list for prescription drugs or medical supplies dispensed by the Program.

(3) A repository may charge a fee of not more than $10 for each prescription drug or medical supply dispensed under the Program.

D. Limitations. A repository in the Donation Program is under no obligation to obtain a prescription drug or medical supply that is not in inventory at the time of the request.

E. Procedure for Dispensing Donated Prescription Drugs or Medical Supplies. A repository in the Donation Program shall dispense donated prescription drugs or medical supplies in compliance with applicable federal and State laws and regulations for dispensing prescription drugs or medical supplies.

F. Procedure for Shipping Donated Prescription Drugs or Medical Supplies. A repository in the Donation Program shall comply with COMAR 10.34.25 when shipping donated prescription drugs or medical supplies to recipients of this Program.

G. Procedures for Disposing of Donated Prescription Drugs or Medical Supplies.

(1) A repository in the Donation Program shall dispose of donated prescription drugs or medical supplies that do not meet the eligibility requirements of Regulation .02 of this chapter.

(2) A repository in the Donation Program shall dispose of donated prescription drugs or medical supplies in compliance with applicable State and federal laws and regulations for disposing of prescription drugs or medical supplies.

(3) A repository shall maintain records of disposal of donated prescription drugs or medical supplies.

H. Determination of Patient Eligibility for the Donation Program.

(1) A recipient of the Donation Program shall be a resident of the State.

(2) A health care practitioner with prescribing authority shall:

(a) Determine, at the health care practitioner's discretion, the financial need of a patient to participate in the Donation Program; and

(b) Indicate on the patient's prescription eligibility for the Donation Program.

I. Recipient Form. Recipients of a donated prescription drug or medical supply under the Donation Program shall sign a Board approved form before receiving the prescription drug or medical supply to confirm that the recipient understands that:

(1) The recipient is receiving prescription drugs or medical supplies that have been donated as part of the Donation Program; and

(2) Entities involved in the Donation Program have immunity from liability in accordance with Health-General Article, §15-607, Annotated Code of Maryland.

Md. Code Regs. 10.34.33.06-1

Regulation .06-1 adopted effective 43:9 Md. R. 530, eff.5/9/2016