Draft Guidance for Industry on Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to Free Clinics; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to Free Clinics." The draft guidance provides information for free clinics that receive donated prescription drug samples from licensed practitioners or other charitable institutions. The draft guidance discusses concerns that have been expressed by certain individuals regarding regulatory requirements of FDA's regulations for drug sample donations. The draft guidance announces that FDA, in the exercise of its enforcement discretion, does not intend to object if a free clinic fails to comply with the requirements in the regulations, while the agency studies the potential impact of its regulations on free clinics.