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 Industry1

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. 
Contains Nonbinding Recommendations 

2

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, lessburdensome 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 

Agency’s 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. 
Contains Nonbinding Recommendations 

3

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, FDA’s 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 Agency’s 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. 
Contains Nonbinding Recommendations 

4

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.