[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: 21CFR203.30]
[Page 104-105]
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. 203.30 Sample distribution by mail or common carrier.
(a) Requirements for drug sample distribution by mail or common
carrier. A manufacturer or authorized distributor of record may
distribute a drug sample to a practitioner licensed to prescribe the
drug that is to be sampled or, at the written request of a licensed
practitioner, to the pharmacy of a hospital or other health care entity,
by mail or common carrier, provided that:
(1) The licensed practitioner executes and submits a written request
to the manufacturer or authorized distributor of record, as set forth in
paragraph (b) of this section, before the delivery of the drug sample;
(2) The manufacturer or authorized distributor of record verifies
with the appropriate State authority that the practitioner requesting
the drug sample is licensed or authorized under State law to prescribe
the drug product;
(3) The recipient executes a written receipt, as set forth in
paragraph (c) of this section, when the drug sample is delivered; and
(4) The receipt is returned to the manufacturer or distributor from
which the drug sample was received.
(b) Contents of the written request form for delivery of samples by
mail or common carrier. (1) A written request for a drug sample to be
delivered by mail or common carrier to a licensed practitioner is
required to contain the following:
[[Page 105]]
(i) The name, address, professional title, and signature of the
practitioner making the request;
(ii) The practitioner's State license or authorization number or,
where a scheduled drug product is requested, the practitioner's Drug
Enforcement Administration number.
(iii) The proprietary or established name and the strength of the
drug sample requested;
(iv) The quantity requested;
(v) The name of the manufacturer and the authorized distributor of
record, if the drug sample is requested from an authorized distributor
of record; and
(vi) The date of the request.
(2) A written request for a drug sample to be delivered by mail or
common carrier to the pharmacy of a hospital or other health care entity
is required to contain, in addition to all of the information in
paragraph (b)(l) of this section, the name and address of the pharmacy
of the hospital or other health care entity to which the drug sample is
to be delivered.
(c) Contents of the receipt to be completed upon delivery of a drug
sample. The receipt is to be on a form designated by the manufacturer or
distributor, and is required to contain the following:
(1) If the drug sample is delivered to the licensed practitioner who
requested it, the receipt is required to contain the name, address,
professional title, and signature of the practitioner or the
practitioner's designee who acknowledges delivery of the drug sample;
the proprietary or established name and strength of the drug sample and
the quantity of the drug sample delivered; and the date of the delivery.
(2) If the drug sample is delivered to the pharmacy of a hospital or
other health care entity at the request of a licensed practitioner, the
receipt is required to contain the name and address of the requesting
licensed practitioner; the name and address of the hospital or health
care entity pharmacy designated to receive the drug sample; the name,
address, professional title, and signature of the person acknowledging
delivery of the drug sample; the proprietary or established name and
strength of the drug sample; the quantity of the drug sample delivered;
and the date of the delivery.
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