Standards and Procedures for Dispensing Donated Prescription Drugs

PURPOSE: This rule contains the criteria by which pharmacies, hospitals and nonprofit clinics will dispense donated drugs under the Prescription Drug Repository Program. (1) A pharmacy, hospital or nonprofit clinic shall dispense donated prescription drugs in compliance with applicable federal and state laws and regulations for dispensing prescription drugs. (2) A pharmacy, hospital or nonprofit clinic shall dispense donated prescription drugs in compliance with section 338.059, RSMo Prescriptions, how labeled; 4 CSR 220-2.130 Drug Repackaging; and 4 CSR 220-3.040 Return and Reuse of Drugs and Devices. (3) A pharmacy, hospital or nonprofit clinic shall have an established mechanism to notify recipients in the event of a drug recall. (4) A pharmacy, hospital or nonprofit clinic shall remove the original donor’s identification from the package when the drug is dispensed. (5) Recipients of a donated drug from the drug repository program shall sign an immunity acceptance record form stating they understand the criminal and civil immunity provisions of the program pursuant to section 196.981, RSMo. The immunity acceptance record shall also include at least the following: (A) The printed name and address of the recipient; (B) The signature of the recipient; (C) The date the form was signed by the recipient; (D) The brand name of the drug received; or the generic name and either the name of the manufacturer or the national drug code number (NDC #); (E) The lot number of the drug if available; (F) The strength of the drug received by the recipient; (G) The quantity of the drug received by the recipient; (H) The name and address of the dispensing pharmacy, hospital or nonprofit clinic; and (I) The dispenser’s initials. (6) Each recipient of a donated drug from the drug repository program shall sign a waiver of the requirement for child-resistant packaging of the Poison Prevention Packaging Act. (7) A pharmacy, hospital or nonprofit clinic may charge the recipient of a donated drug a handling fee, not to exceed a maximum of two hundred percent (200%) of the standard Medicaid professional dispensing fee to cover stocking and dispensing costs. Communicable Disease Prevention (8) A pharmacy, hospital or nonprofit clinic may transfer donated drugs to another governmental entity or nonprofit private entity, to be dispensed to persons who meet the eligibility requirements of the program, when the other governmental entity or nonprofit private entity is a pharmacy, hospital or nonprofit clinic. (A) The transferring pharmacy, hospital or nonprofit clinic shall be licensed as a drug distributor with the Board of Pharmacy. (B) If the transferring pharmacy, hospital or nonprofit clinic is a covered entity under the Health Portability and Accountability Act (HIPAA), it shall comply with HIPAA regarding the disclosure of any personal health information that may occur as a result of the transfer of a donated drug. A copy of any authorization to release patient identifying information received by the transferring pharmacy, hospital or nonprofit clinic in relation to a donated drug shall be provided to the pharmacy, hospital or nonprofit clinic receiving any transferred drug. (C) Both the transferring and receiving pharmacy, hospital or nonprofit clinic shall maintain a record that includes: 1. The brand name of the drug received; or the generic name and either the name of the manufacturer or the national drug code number (NDC #); 2. The lot number of the drug, if available; 3. The strength of the drug; 4. The quantity of the drug; 5. The name and address of both the transferring and receiving pharmacy, hospital or nonprofit clinic; and 6. The date of the transfer. AUTHORITY: section 196.984, RSMo Supp. 2004.* Emergency rule filed Dec. 15, 2004, effective Jan. 1, 2005, expired June 29, 2005. Original rule filed Dec. 15, 2004, effective June 30, 2005.. *Original authority: 196.984, RSMo 2004.