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

摘要

The Food and Drug Administration (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.