[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.39]
[Page 109-110]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 203 PRESCRIPTION DRUG MARKETING--Table of Contents
Subpart D Samples
Sec. 203.39 Donation of drug samples to charitable institutions.
A charitable institution may receive a drug sample donated by a
licensed practitioner or another charitable institution for dispensing
to a patient of the charitable institution, or donate a drug sample to
another charitable institution for dispensing to its patients, provided
that the following requirements are met:
(a) A drug sample donated by a licensed practitioner or donating
charitable institution shall be received by a charitable institution in
its original, unopened packaging with its labeling intact.
(b) Delivery of a donated drug sample to a recipient charitable
institution shall be completed by mail or common carrier, collection by
an authorized agent or employee of the recipient charitable institution,
or personal delivery by a licensed practitioner or an agent or employee
of the donating charitable institution. Donated drug samples shall be
placed by the donor in a sealed carton for delivery to or collection by
the recipient charitable institution.
(c) A donated drug sample shall not be dispensed to a patient or be
distributed to another charitable institution until it has been examined
by a licensed practitioner or registered pharmacist at the recipient
charitable institution to confirm that the donation record accurately
describes the drug sample delivered and that no drug sample is
adulterated or misbranded for any reason, including, but not limited to,
the following:
(1) The drug sample is out of date;
(2) The labeling has become mutilated, obscured, or detached from
the drug sample packaging;
(3) The drug sample shows evidence of having been stored or shipped
under conditions that might adversely affect its stability, integrity,
or effectiveness;
(4) The drug sample is for a prescription drug product that has been
recalled or is no longer marketed; or
(5) The drug sample is otherwise possibly contaminated,
deteriorated, or adulterated.
(d) The recipient charitable institution shall dispose of any drug
sample found to be unsuitable by destroying it
[[Page 110]]
or by returning it to the manufacturer. The charitable institution shall
maintain complete records of the disposition of all destroyed or
returned drug samples.
(e) The recipient charitable institution shall prepare at the time
of collection or delivery of a drug sample a complete and accurate
donation record, a copy of which shall be retained by the recipient
charitable institution for at least 3 years, containing the following
information:
(1) The name, address, and telephone number of the licensed
practitioner (or donating charitable institution);
(2) The manufacturer, brand name, quantity, and lot or control
number of the drug sample donated; and
(3) The date of the donation.
(f) Each recipient charitable institution shall maintain complete
and accurate records of donation, receipt, inspection, inventory,
dispensing, redistribution, destruction, and returns sufficient for
complete accountability and auditing of drug sample stocks.
(g) Each recipient charitable institution shall conduct, at least
annually, an inventory of prescription drug sample stocks and shall
prepare a report reconciling the results of each inventory with the most
recent prior inventory. Drug sample inventory discrepancies and
reconciliation problems shall be investigated by the charitable
institution and reported to FDA.
(h) A recipient charitable institution shall store drug samples
under conditions that will maintain the sample's stability, integrity,
and effectiveness, and will ensure that the drug samples will be free of
contamination, deterioration, and adulteration.
(i) A charitable institution shall notify FDA within 5 working days
of becoming aware of a significant loss or known theft of prescription
drug samples.
Back to Top
© 2007 Betterchem Corp.
|
