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Guidance for Industry
Prescription Drug Marketing Act — Donation of Prescription Drug
Samples to Free Clinics
(PDF version of this document)
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
March 2006
Compliance
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
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.
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.
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.
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 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.
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 guidance
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.
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 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.
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Date created: March 14, 2006 |
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