[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.30]

[Page 87]
 
                        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:
    (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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