[Federal Register: June 27, 2002 (Volume 67, Number 124)]
[Notices]               
[Page 43330-43331]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn02-95]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food And Drug Administration

[Docket No. 02D-0260]

 
Draft Guidance for Industry on Prescription Drug Marketing Act 
Regulations for 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 
availability of a draft guidance for industry entitled ``Prescription 
Drug Marketing Act Regulations for Donation of Prescription Drug 
Samples to Free Clinics.'' The draft guidance provides information for 
free clinics that receive donated prescription drug samples from 
licensed practitioners or other charitable institutions. The draft 
guidance discusses concerns that have been expressed by certain 
individuals regarding regulatory requirements of FDA's regulations for 
drug sample donations. The draft guidance announces that FDA, in the 
exercise of its enforcement discretion, does not intend to object if a 
free clinic fails to comply with the requirements in the regulations, 
while the agency studies the potential impact of its regulations on 
free clinics.

DATES:  Submit written or electronic comments on the draft guidance by 
September 25, 2002. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFD-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20857. Submit electronic comments to http://www.fda.gov/dockets/
ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lee D. Korb, 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 draft guidance for industry 
entitled ``Prescription Drug Marketing Act Regulations for 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) (21 CFR 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.

[[Page 43331]]

    The draft guidance announces that FDA, in the exercise of its 
enforcement discretion, does not intend to object if a free clinic 
fails to comply with the requirements in Sec. 203.39 while the agency 
studies the potential impact of this regulation on the ability of free 
clinics to receive and distribute prescription drug samples. For the 
purposes of the draft guidance, a ``free clinic'' is 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 and are expected to comply with 
Sec. 203.39.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on enforcement 
of Prescription Drug Marketing Act Regulations for Donation of 
Prescription Drug Samples to Free Clinics. 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 Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance by 
September 25, 2002. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The draft guidance and received comments may be seen in 
the Dockets Management Branch 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: June 17, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-16160 Filed 6-26-02; 8:45 am]
BILLING CODE 4160-01-S