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10.34.33.00.htm 10.34.33.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 34 BOARD OF PHARMACY Chapter 33 Prescription Drug Repository Program Authority: Health-General Article, §15-601―15-609, Annotated Code of Maryland
10.34.33.01.htm 10.34.33.01. 01 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Board" means the State Board of Pharmacy.. 1-1) “Donation program” means pharmacies that voluntarily participate as a drop-off site or repository, or both, to accept donated drugs or medical supplies for purposes of re-dispensing those donated drugs or medical supplies to needy individuals.1-2) “Disposal program” means pharmacies that voluntarily participate as re
10.34.33.01-1.htm 10.34.33.01-1. 01-1 Incorporation by Reference.. In this chapter, the Secure and Responsible Drug Disposal Act of 2010, 21 U.S.C. 822 (as amended) has been incorporated by reference.
10.34.33.02.htm 10.34.33.02. 02 Donation Program ― Eligible Drugs.. A. Prescription drugs or medical supplies may be donated at a drop-off site.. B. Prescription drugs or medical supplies may be accepted for dispensing if the prescription drugs and medical supplies are:1) In their original unopened and sealed packaging; or. 2) Packaged in single unit doses when the outside packaging is opened if the single unit dose packaging is undisturbed.
10.34.33.03.htm 10.34.33.03. 03 Donation Program ― Ineligible Drugs.. A. Prescription drugs or medical supplies may not be accepted for dispensing if the prescription drugs or medical supplies:1) Bear an expiration date that is less than 90 days from the date the drug is donated to ensure the potency and quality of the prescription drugs or medical supplies;2) Have been adulterated, according to the standards of Health-General Article, §21-216, Annotated Code of Maryland, because adulterated prescription
10.34.33.04.htm 10.34.33.04. 04 Donation Program ― Donor Form.. A. A donor of a prescription drug or medical supply shall sign a form containing the following statements:1) That the donor is the owner or the owner's representative of the prescription drug or medical supply; and2) That the donor intends to voluntarily donate the prescription drug or medical supply to the Program.B. The drop-off site shall:. 1) Require that the donor form contain:. a) The signature of the donor or the donor's representative;.
10.34.33.05.htm 10.34.33.05. 05 Donation Program ― Drop-Off Sites Requirements.. A. In order to become a drop-off site, a pharmacy or other health care facility:. 1) Shall submit an application to the Board to be designated as a voluntary drop-off site;. 2) Shall be in good standing with the Board or the Office of Health Care Quality;. 3) May not have a final disciplinary order issued against it by a health occupations board;. 4) May not be owned or operated by a health care practitioner who has not f
10.34.33.06.htm 10.34.33.06. 06 Repositories ― General Requirements.. In order to become a repository, a pharmacy:. A. Shall submit an application to the Board to be designated as a repository;. B. Shall indicate on the application to the Board if the applicant intends to:. 1) Participate in the Donation Program;. 2) Participate in the Disposal Program by collecting only non-controlled dangerous substances and medical supplies for safe disposal; or3) Participate in the Disposal Program by collecti
10.34.33.06-1.htm 10.34.33.06-1. 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 requ
10.34.33.07.htm 10.34.33.07. 07 Disposal Program ― Requirements.. A. Pharmacies that collect returned prescription drugs or medical supplies for proper disposal shall be approved by the Board as repositories.B. Repositories that collect only non-controlled dangerous substances for proper disposal shall:. 1) Dispose of prescription drugs or medical supplies collected for disposal in compliance with applicable State and federal laws and regulations;2) Have policies and procedures regarding the safe
10.34.33.9999.htm 10.34.33.9999. Administrative History Effective date: January 29, 2007 (34:2 Md. R. 137) ―. Chapter revised effective May 9, 2016 (43:9 Md. R. 530).
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