Current through Register Vol. XLI, No. 25, June 21, 2024
Section 15-13-5 - Prescription Drug Samples5.1. Except insofar as it may conflict with federal law, charitable clinic pharmacies are exempt from any State law or rule which restricts who may receive sample drugs from a manufacturer. Specifically, unless it conflicts with federal law, a charitable clinic pharmacy may accept donated prescription drugs in their unbroken original packaging from pharmacies, licensed prescribers, wholesalers, or manufacturers provided appropriate records of transfer, donation, and receipt are maintained: Provided That the samples have been stored under the proper conditions required by the manufacturer and applicable law to prevent deterioration or contamination. However, a charitable clinic pharmacy may only receive, possess, and dispense prescription drug samples if the following conditions are satisfied: 5.1.1. The samples are dispensed at no charge to qualified patients of that charitable clinic pharmacy;5.1.2. The samples are possessed in compliance with the Federal Prescription Drug Marketing Act of 1987, 21 U.S.C. §301 et seq, or its successor;5.1.3. The samples are in the original container in which they were placed by the manufacturer and the container is clearly marked sample;5.1.4. Prior to being furnished or dispensed, the samples have been stored under the proper conditions to prevent deterioration or contamination;5.1.5. The samples are clearly marked with an expiration date and lot number;5.1.6. The samples are not expired; and5.1.7. The samples are not a controlled substance.5.2. If donated samples are received which do not comply with Section 15-13-5.1, then they must be refused, returned, or properly disposed of by the charitable clinic pharmacy.5.3. A charitable clinic pharmacy may not sell, purchase, or trade prescription drug samples.5.4. A Charitable Clinic Pharmacy dispensing a sample drug shall comply with the following: 5.4.1. A pharmacist in a charitable clinic pharmacy must have a valid prescription prior to dispensing a sample drug to a patient.5.4.2. The charitable clinic pharmacy must determine the eligibility requirements for a patient to receive a sample drug.5.4.3. The sample drug is dispensed: 5.4.3.a. In the original container in which it was placed by its manufacturer where the container is clearly marked as sample; or5.4.3.b. By removing the sample drug from the original container only if the prescription label on the appropriate container clearly states that the drug dispensed is a sample drug.5.4.4. Nothing is this rule shall restrict a prescribing practitioner from providing samples in their original container from being given to the practitioner's patients in accordance with federal law.