U.S. Food and Drug Administration

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

I. INTRODUCTION

This 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 in 21 CFR 203.39 for drug sample donations.  The guidance announces that FDA intends to propose revisions to § 203.39 to reduce the burden on free clinics while maintaining certain minimal requirements aimed at ensuring the integrity of the samples stored and dispensed by clinics.   In the interim, FDA, in the exercise of its enforcement discretion, does not intend to object if a free clinic fails to comply with certain requirements in § 203.39.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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