Pharmacist FAQsFrequently Asked Questions for Pharmacists on Sample Medications Q: Are Physician Assistants and Nurse Practitioners who only dispense sample medications required to register with the Board under Rule .1703? A: The Board has received numerous inquiries from physician assistants and nurse practitioners about Board of Pharmacy Rule .1703. PAs and NPs have asked whether that rule’s registration, permitting, and oversight requirements apply when a PA or NP is simply handing out prescription drug samples to patients. The Board does not interpret Rule .1703’s requirements to apply to a PA or NP who is engaged in traditional sampling – i.e., handing out, free of any charge (whether direct or indirect), starter doses or packets of prescription drug samples received from a prescription drug manufacturer in compliance with the Prescription Drug Marketing Act. -------------------------------------------------------------------------------- Q: Can prescription drug samples be donated to free clinics? FDA is announcing the availability of a guidance for industry entitled "Prescription Drug Marketing Act - Donation of Prescription Drug Samples to Free Clinics." The guidance provides information for free clinics that receive donated prescription drug samples from licensed practitioners or other charitable institutions. The guidance discusses concerns that have been expressed by certain individuals regarding regulatory requirements for drug sample donations. The guidance announces that FDA, after reviewing an independent study report analyzing the potential effects of the regulations on free clinics, has decided to propose revisions to those regulations. In the interim, FDA intends to exercise its enforcement discretion and does not intend to object if a free clinic fails to comply with certain regulatory requirements for drug sample donations. Copies of the guidance may be obtained at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070317.pdf -------------------------------------------------------------------------------- Q: What is the proper procedure to follow when dispensing sample medications? A: Questions frequently come to the Board office regarding the proper dispensing of sample medications. First of all it needs to be stated that there is no exemption from the packaging, labeling, and record keeping requirements of law for sample prescription drugs. State law clearly provides for labeling of prescription drugs dispensed to the public at G.S. 106-134.1(b). This includes a label affixed to the container with the name of the patient, directions for use, etc. Federal law also provides, as a general rule, that prescription drugs shall be dispensed in child resistant (safety closure) containers. The Board's rule on patient counseling and prospective drug use review also applies to sample prescription drugs. While pharmacists, nurses, physicians and others who encounter samples in their practice need to be cognizant of dispensing requirements, problems are most likely to arise in private litigation. If a child were to become injured after consuming sample medication which was not in a safety-closure container it is questionable whether malpractice insurance would be effective when the current practice is not in conformance with the law. FDA Regulatory Information for dispensing sample medication may be obtained here:
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