[Federal Register Volume 71, Number 49 (Tuesday, March 14, 2006)]
[Notices]
[Pages 13129-13130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0260] (formerly Docket No. 02D-0260)


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

[[Page 13130]]

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.

DATES: General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the guidance to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Meredith S. Francis, Office of 
Regulatory Policy (HFD-7), Center for Drug Evaluation and Research, 
5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Prescription Drug Marketing Act--Donation of Prescription 
Drug Samples to Free Clinics.'' Section 203.39 (21 CFR 203.39) of the 
agency's regulations sets forth requirements for donation of 
prescription drug samples to charitable institutions. ``Charitable 
institution'' or ``charitable organization'' is defined in Sec.  
203.3(f) 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 Sec.  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 be maintained by the institution and retained for 
a minimum of 3 years.
    In the Federal Register of June 27, 2002 (67 FR 43330), FDA 
announced the availability of a draft guidance entitled ``Prescription 
Drug Marketing Act Regulations for Donation of Prescription Drug 
Samples to Free Clinics.'' The draft guidance announced that FDA, in 
the exercise of its enforcement discretion, did not intend to object if 
a free clinic failed to comply with the requirements in Sec.  203.39. 
The draft guidance defined the term ``free clinic,'' which is not 
otherwise defined in the Federal Food, Drug, and Cosmetic Act or 
regulations, as a charitable institution or organization, under Sec.  
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. According to the draft guidance, FDA intended to exercise 
enforcement discretion while the agency studied the potential impact of 
the regulation on the ability of free clinics to receive and distribute 
prescription drug samples. Interested persons were given the 
opportunity to submit comments on the draft guidance by September 25, 
2002.
    Since issuing the draft guidance, FDA has received a completed 
study report from Eastern Research Group (ERG) analyzing the burden 
imposed on free clinics by the requirements in Sec.  203.39 and the 
potential regulatory alternatives. According to the ERG study report, 
implementing Sec.  203.39 as written could impose a significant 
financial burden on free clinics. Based in part on the study report's 
conclusions, FDA is announcing today that it intends to exercise 
enforcement discretion while the agency proposes revisions to Sec.  
203.39 as applied to free clinics. Specifically, as FDA works to 
propose regulatory revisions, the agency does not intend to object if a 
free clinic fails to comply with certain parts of the regulation. The 
guidance clarifies that the agency's exercise of enforcement discretion 
with regard to certain requirements of Sec.  203.39 will not extend to 
fraud or other illegal conduct involving drug samples, and that the 
agency could, at its discretion, initiate enforcement action for 
violations of any and all applicable statutory and regulatory 
provisions implicated by fraudulent or illegal activity. We note also 
that neither this notice, nor its corresponding guidance, affects or 
alters any requirements imposed by the U.S. Drug Enforcement 
Administration (DEA) on any free clinic, person, or other entity with 
regard to controlled substances donated to those entities. All DEA 
requirements relating to controlled substances remain fully in effect.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). It represents the agency'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.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http:www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3532 Filed 3-13-06; 8:45 am]
BILLING CODE 4160-01-S