[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: 21CFR203.31]
[Page 105-107]
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. 203.31 Sample distribution by means other than mail or common carrier
(direct delivery by a representative or detailer).
(a) Requirements for drug sample distribution by means other than
mail or common carrier. A manufacturer or authorized distributor of
record may distribute by means other than mail or common carrier, by a
representative or detailer, a drug sample to a practitioner licensed to
prescribe the drug to be sampled or, at the written request of such a
licensed practitioner, to the pharmacy of a hospital or other health
care entity, provided that:
(1) The manufacturer or authorized distributor of record receives
from the licensed practitioner a written request signed by the licensed
practitioner 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) A receipt is signed by the recipient, as set forth in paragraph
(c) of this section, when the drug sample is delivered;
(4) The receipt is returned to the manufacturer or distributor; and
(5) The requirements of paragraphs (d) through (e) of this section
are met.
(b) Contents of the written request forms for delivery of samples by
a representative. (1) A written request for delivery of a drug sample by
a representative 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
[[Page 106]]
from an authorized distributor of record; and
(vi) The date of the request.
(2) A written request for delivery of a drug sample by a
representative 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) 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 received at the address of 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; the quantity of the drug sample delivered; and the date of the
delivery.
(2) If the drug sample is received by 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.
(d) Inventory and reconciliation of drug samples of manufacturers'
and distributors' representatives. Each drug manufacturer or authorized
distributor of record that distributes drug samples by means of
representatives shall conduct, at least annually, a complete and
accurate physical inventory of all drug samples. All drug samples in the
possession or control of each manufacturer's and distributor's
representatives are required to be inventoried and the results of the
inventory are required to be recorded in an inventory record, as
specified in paragraph (d)(1) of this section. In addition,
manufacturers and distributors shall reconcile the results of the
physical inventory with the most recently completed prior physical
inventory and create a report documenting the reconciliation process, as
specified in paragraph (d)(2) of this section.
(1) The inventory record is required to identify all drug samples in
a representative's stock by the proprietary or established name, dosage
strength, and number of units.
(2) The reconciliation report is required to include:
(i) The inventory record for the most recently completed prior
inventory;
(ii) A record of each drug sample shipment received since the most
recently completed prior inventory, including the sender and date of the
shipment, and the proprietary or established name, dosage strength, and
number of sample units received;
(iii) A record of drug sample distributions since the most recently
completed inventory showing the name and address of each recipient of
each sample unit shipped, the date of the shipment, and the proprietary
or established name, dosage strength, and number of sample units
shipped. For the purposes of this paragraph and paragraph (d)(2)(v) of
this section, ``distributions'' includes distributions to health care
practitioners or designated hospital or health care entity pharmacies,
transfers or exchanges with other firm representatives, returns to the
manufacturer or authorized distributor, destruction of drug samples by a
sales representative, and other types of drug sample dispositions. The
specific type of distribution must be specified in the record;
(iv) A record of drug sample thefts or significant losses reported
by the representative since the most recently completed prior inventory,
including the approximate date of the occurrence and the proprietary or
established name, dosage strength, and number of sample units stolen or
lost; and
(v) A record summarizing the information required by paragraphs
(d)(2)(ii) through (d)(2)(iv) of this section. The
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record must show, for each type of sample unit (i.e., sample units
having the same established or proprietary name and dosage strength),
the total number of sample units received, distributed, lost, or stolen
since the most recently completed prior inventory. For example, a
typical entry in this record may read ``50 units risperidone (1 mg)
returned to manufacturer'' or simply ``Risperidone (1 mg)/50/returned to
manufacturer.''
(3) Each drug manufacturer or authorized distributor of record shall
take appropriate internal control measures to guard against error and
possible fraud in the conduct of the physical inventory and
reconciliation, and in the preparation of the inventory record and
reconciliation report.
(4) A manufacturer or authorized distributor of record shall
carefully evaluate any apparent discrepancy or significant loss revealed
through the inventory and reconciliation process and shall fully
investigate any such discrepancy or significant loss that cannot be
justified.
(e) Lists of manufacturers' and distributors' representatives. Each
drug manufacturer or authorized distributor of record who distributes
drug samples by means of representatives shall maintain a list of the
names and addresses of its representatives who distribute drug samples
and of the sites where drug samples are stored.
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