Guidance for Industry 
Prescription Drug Marketing 
Act  Donation of Prescription 
Drug Samples to Free Clinics 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
March 2006 
Compliance 
   
Guidance for Industry 
 
Prescription Drug Marketing 
Act  Donation of Prescription 
Drug Samples to Free Clinics 
 
 
Additional copies are available from: 
Office of Training and Communication 
Division of Drug Information, HFD-240 
Center for Drug Evaluation and Research 
Food and Drug Administration 
5600 Fishers Lane 
Rockville, MD  20857 
(Tel) 301-827-4573 
 http://www.fda.gov/cder/guidance/index.htm 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
  
March 2006 
Compliance
   
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION.............................................................................................................1 
II.  BACKGROUND...............................................................................................................1 
III.  DISCUSSION....................................................................................................................3 
   
Contains Nonbinding Recommendations 
 
1
Guidance for Industry  
 
Prescription Drug Marketing Act  Donation of Prescription Drug 
Samples to Free Clinics 
 
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. 
 
II.  BACKGROUND 
 
The Prescription Drug Marketing Act (PDMA) (Public Law 100-293) was enacted on April 22, 
1988, and was modified by the Prescription Drug Amendments (PDA) (Public Law 102-353, 106 
Stat. 941) on August 26, 1992.  The PDMA, as modified by the PDA, amended sections 301, 
303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 331, 333, 
353, 381) to, among other things, establish requirements for distribution of prescription drug 
samples.  Section 503(d) of the Act prohibits the distribution of a drug sample except by the 
manufacturer or an authorized distributor of record.  For the purposes of section 503(d) of the 
Act, distribute does not include the provision of a drug sample to a patient by a licensed 
practitioner, a health care professional acting at the direction and under the supervision of a 
licensed practitioner, or a hospital or health care entity pharmacy acting at the direction of a 
licensed practitioner. 
                                                 
1 This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) at the Food and Drug 
Administration.  
  1  
Contains Nonbinding Recommendations 
 
 
On December 3, 1999, the Agency published final regulations in part 203 (21 CFR part 203) 
implementing the PDMA.  The regulations set forth various requirements for the distribution of 
prescription drug samples by manufacturers and authorized distributors of record to practitioners 
licensed to prescribe such samples.  In addition, the regulations addressed the practice whereby 
licensed practitioners donate unused prescription drug samples to charitable institutions such as 
free clinics, nursing homes, and other charitable health care entities for dispensing to patients, or 
for further donation to another charity for dispensing to its patients.  The Agency recognized the 
importance of this practice and concluded that charitable donation of drug samples is permissible 
under PDMA, provided that a system of controls is in place to provide accountability and 
oversight for such donations and to minimize the potential for drug diversion. 
 
The requirements for donation of drug samples to charitable institutions are set forth in  203.39 
of the final PDMA rule.  Charitable institution or charitable organization is defined in  
203.3(f) of the final rule as a nonprofit hospital, health care entity, organization, institution, 
foundation, association, or corporation that has been granted an exemption under section 
501(c)(3) of the Internal Revenue Code of 1954, as amended.  Under  203.39, a charitable 
institution may receive drug samples donated by a licensed practitioner or another charitable 
institution for dispensing to its patients, or may donate a drug sample to another charitable 
institution for dispensing to its patients, provided certain requirements are met.  These 
requirements include, among other things, that a drug sample donated to a charitable institution 
must be inspected by a licensed practitioner or registered pharmacist and that drug sample receipt 
and distribution records must be kept by the institution for a minimum of 3 years.  
 
On October 23, 2000, FDA received a letter submitted on behalf of the North Carolina 
Association of Free Clinics asserting that the recordkeeping requirements in  203.39 are 
unnecessarily burdensome and would force many small and underfunded free clinics to 
discontinue dispensing donated drug samples to their patients.  The letter requested, among other 
things, that the relevant provisions of the final rule be stayed indefinitely until alternative, less-
burdensome regulatory provisions are adopted by FDA.  In response to the concerns expressed in 
the letter, FDA sent a reply on December 7, 2000, indicating that in the exercise of its 
enforcement discretion the Agency did not intend to object if free clinics did not comply with 
certain specified portions of the regulations.  For example, FDA stated that to conserve 
professional resources the Agency did not intend to object if the inspection of incoming drug 
samples required under  203.39(c) was conducted by a person authorized by a licensed 
practitioner affiliated with the free clinic, rather than a licensed practitioner.  However, FDA 
stated that it would expect compliance with certain other basic requirements.  
 
On June 22, 2001, FDA met with representatives of several free clinics to discuss their concerns 
about the requirements noted in the December 7, 2000, letter.  They said that despite the 
Agencys attempt to reduce burdens on free clinics, some clinics would be forced to close their 
doors if the recordkeeping provisions and certain other requirements were imposed.  FDA and 
the Department of Health and Human Services received further correspondence relating to the 
requirements in  203.39, dated July 17, 2001, and August 17, 2001.   
 
  2  
Contains Nonbinding Recommendations 
 
In response to the concerns expressed by free clinics, FDA commissioned a study to (1) 
determine the burden imposed on free clinics by the requirements in  203.39, and (2) evaluate 
regulatory alternatives.  In the interim, FDA issued a draft guidance2 announcing that while the 
study was being conducted, the Agency would exercise its enforcement discretion and did not 
intend to object if a free clinic failed to comply with the requirements of  203.39.   FDA 
contracted with Eastern Research Group (ERG) to perform the study, which was completed in 
2003.   According to the ERG study report, implementing the requirements set forth in  203.39 
as written could impose a significant financial burden on free clinics.  The requirements would 
be particularly burdensome for small free clinics having budgets of less than $200,000 per year.  
 
In light of the information currently available to the Agency, FDA has decided to propose 
revisions to  203.39 as applied to free clinics.  In particular, FDAs decision is based on (1) the 
concerns expressed by free clinics, (2) the ERG report, (3) the fact that, to date, the Agency is 
unaware of any significant evidence of diversion of donated drug samples from free clinics, and 
(4) the Agencys appreciation that the donation of drug samples to free clinics serves an 
important public health role (i.e., providing health care to indigent, uninsured, and underinsured 
populations).  While it works to develop proposed regulations, FDA has decided to finalize this 
guidance. 
 
III.  DISCUSSION 
 
FDA recognizes the need to balance the goal of providing health care services to those in need 
against the objectives of the PDMA.  To that end, FDA plans to propose revisions to  203.39 to 
reduce the burden on free clinics while maintaining certain minimum requirements aimed at 
ensuring the integrity of samples stored and dispensed by the clinics.  In the interim, FDA is 
announcing its intent to exercise its enforcement discretion in accordance with the following 
policy. 
 
The term free clinic is not currently defined in the Act or regulations.  For the purposes of this 
guidance, the Agency considers a free clinic to be a charitable institution or organization, under  
203.3(f), that actually provides health care services and relies in whole or part on drug donations 
and volunteer help to achieve its goals.  Thus, charitable institutions that receive donated drug 
samples but do not provide health care services, or that provide health care services but do not 
rely at least in part on drug donations and volunteer help to provide those services, would not be 
considered free clinics.  As FDA works to revise  203.39, it will welcome comment on the 
appropriateness of using this definition of free clinic in the regulation. 
 
During the time necessary to engage in the rulemaking process, FDA intends to exercise its 
enforcement discretion with regard to certain provisions of  203.39 as applied to free clinics.  
Specifically, FDA, in the exercise of its enforcement discretion, does not intend to object if a free 
clinic fails to comply with  203.39(b), (d), (e), (f), and (g).   For the most part, these subsections 
focus on recordkeeping requirements.  FDA does, however, expect free clinics to comply with  
203.39(a), (c), (h), and (i).  For the most part, these subsections focus on ensuring the integrity of 
samples stored and dispensed by clinics, and should not be too onerous for free clinics to comply 
                                                 
2 In June 2002 (67 FR 43330), FDA made available a draft guidance document that is superseded by this guidance. 
  3  
Contains Nonbinding Recommendations 
 
with and still operate effectively.   Moreover, with regard to  203.39(c), recognizing the 
limitations on the professional resources of free clinics, FDA does not intend to object if the 
required examination of donated samples is performed by any staff member designated to do so 
by a licensed practitioner or registered pharmacist affiliated with the free clinic.    
 
The Agency wishes to clarify that its exercise of enforcement discretion with regard to certain 
requirements of  203.39 will not extend to fraud or other illegal conduct with drug samples.  
Thus, if a free clinic or its employees were found to be selling prescription drug samples or to be 
otherwise illegally diverting them, the Agency could, at its discretion, initiate enforcement action 
against the clinic or the employees for the misconduct, including violations of any and all 
applicable statutory and regulatory provisions.  The Agency also notes that nothing in this 
guidance or its corresponding notice relieves any person or entity from the reporting, or other 
requirements, imposed by the U. S. Drug Enforcement Administration (DEA) with regard to 
controlled substances donated to free clinics. 
  4