[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.3]

[Page 87-89]
 
                        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 A_General Provisions
 
Sec. 203.3  Definitions.

    (a) The act means the Federal Food, Drug, and Cosmetic Act, as 
amended (21 U.S.C. 301 et seq.).
    (b) Authorized distributor of record means a distributor with whom a 
manufacturer has established an ongoing relationship to distribute such 
manufacturer's products.
    (c) Blood means whole blood collected from a single donor and 
processed either for transfusion or further manufacturing.
    (d) Blood component means that part of a single-donor unit of blood 
separated by physical or mechanical means.
    (e) Bulk drug substance means any substance that is represented for 
use in a drug and that, when used in the manufacturing, processing, or 
packaging of a drug, becomes an active ingredient or a finished dosage 
form of the drug, but the term does not include intermediates used in 
the synthesis of such substances.
    (f) Charitable institution or charitable organization means 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.
    (g)  Common control means the power to direct or cause the direction 
of the management and policies of a person or an organization, whether 
by ownership of stock, voting rights, by contract, or otherwise.
    (h)  Distribute means to sell, offer to sell, deliver, or offer to 
deliver a drug to a recipient, except that the term ``distribute'' does 
not include:

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    (1) Delivering or offering to deliver a drug by a common carrier in 
the usual course of business as a common carrier; or
    (2) Providing of a drug sample to a patient by:
    (i) A practitioner licensed to prescribe such drug;
    (ii) A health care professional acting at the direction and under 
the supervision of such a practitioner; or
    (iii) The pharmacy of a hospital or of another health care entity 
that is acting at the direction of such a practitioner and that received 
such sample in accordance with the act and regulations.
    (i)  Drug sample means a unit of a prescription drug that is not 
intended to be sold and is intended to promote the sale of the drug.
    (j) Drug coupon means a form that may be redeemed, at no cost or at 
reduced cost, for a drug that is prescribed in accordance with section 
503(b) of the act.
    (k) Electronic record means any combination of text, graphics, data, 
audio, pictorial, or other information representation in digital form 
that is created, modified, maintained, archived, retrieved, or 
distributed by a computer system.
    (l) Electronic signature means any computer data compilation of any 
symbol or series of symbols executed, adopted, or authorized by an 
individual to be the legally binding equivalent of the individual's 
handwritten signature.
    (m) Emergency medical reasons include, but are not limited to, 
transfers of a prescription drug between health care entities or from a 
health care entity to a retail pharmacy to alleviate a temporary 
shortage of a prescription drug arising from delays in or interruption 
of regular distribution schedules; sales to nearby emergency medical 
services, i.e., ambulance companies and fire fighting organizations in 
the same State or same marketing or service area, or nearby licensed 
practitioners, of drugs for use in the treatment of acutely ill or 
injured persons; provision of minimal emergency supplies of drugs to 
nearby nursing homes for use in emergencies or during hours of the day 
when necessary drugs cannot be obtained; and transfers of prescription 
drugs by a retail pharmacy to another retail pharmacy to alleviate a 
temporary shortage; but do not include regular and systematic sales to 
licensed practitioners of prescription drugs that will be used for 
routine office procedures.
    (n) FDA means the U.S. Food and Drug Administration.
    (o)  Group purchasing organization means any entity established, 
maintained, and operated for the purchase of prescription drugs for 
distribution exclusively to its members with such membership consisting 
solely of hospitals and health care entities bound by written contract 
with the entity.
    (p)  Handwritten signature means the scripted name or legal mark of 
an individual handwritten by that individual and executed or adopted 
with the present intention to authenticate a writing in a permanent 
form. The act of signing with a writing or marking instrument such as a 
pen or stylus is preserved. The scripted name or legal mark, while 
conventionally applied to paper, may also be applied to other devices 
that capture the name or mark.
    (q) Health care entity means any person that provides diagnostic, 
medical, surgical, or dental treatment, or chronic or rehabilitative 
care, but does not include any retail pharmacy or any wholesale 
distributor. A person cannot simultaneously be a ``health care entity'' 
and a retail pharmacy or wholesale distributor.
    (r) Licensed practitioner means any person licensed or authorized by 
State law to prescribe drugs.
    (s) Manufacturer means any person who is a manufacturer as defined 
by Sec. 201.1 of this chapter.
    (t)  Nonprofit affiliate means any not-for-profit organization that 
is either associated with or a subsidiary of a charitable organization 
as defined in section 501(c)(3) of the Internal Revenue Code of 1954.
    (u) Ongoing relationship means an association that exists when a 
manufacturer and a distributor enter into a written agreement under 
which the distributor is authorized to distribute the manufacturer's 
products for a period of time or for a number of shipments. If

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the distributor is not authorized to distribute a manufacturer's entire 
product line, the agreement must identify the specific drug products 
that the distributor is authorized to distribute.
    (v)  PDA means the Prescription Drug Amendments of 1992.
    (w) PDMA means the Prescription Drug Marketing Act of 1987.
    (x) Person includes any individual, partnership, corporation, or 
association.
    (y) Prescription drug means any drug (including any biological 
product, except for blood and blood components intended for transfusion 
or biological products that are also medical devices) required by 
Federal law (including Federal regulation) to be dispensed only by a 
prescription, including finished dosage forms and bulk drug substances 
subject to section 503(b) of the act.
    (z)  Representative means an employee or agent of a drug 
manufacturer or distributor who promotes the sale of prescription drugs 
to licensed practitioners and who may solicit or receive written 
requests for the delivery of drug samples. A detailer is a 
representative.
    (aa) Sample unit means a packet, card, blister pack, bottle, 
container, or other single package comprised of one or more dosage units 
of a prescription drug sample, intended by the manufacturer or 
distributor to be provided by a licensed practitioner to a patient in an 
unbroken or unopened condition.
    (bb) Unauthorized distributor means a distributor who does not have 
an ongoing relationship with a manufacturer to sell or distribute its 
products.
    (cc)  Wholesale distribution means distribution of prescription 
drugs to persons other than a consumer or patient, but does not include:
    (1) Intracompany sales;
    (2) The purchase or other acquisition by a hospital or other health 
care entity that is a member of a group purchasing organization of a 
drug for its own use from the group purchasing organization or from 
other hospitals or health care entities that are members of such 
organizations;
    (3) The sale, purchase, or trade of a drug or an offer to sell, 
purchase, or trade a drug by a charitable organization to a nonprofit 
affiliate of the organization to the extent otherwise permitted by law;
    (4) The sale, purchase, or trade of a drug or an offer to sell, 
purchase, or trade a drug among hospitals or other health care entities 
that are under common control;
    (5) The sale, purchase, or trade of a drug or an offer to sell, 
purchase, or trade a drug for emergency medical reasons;
    (6) The sale, purchase, or trade of a drug, an offer to sell, 
purchase, or trade a drug, or the dispensing of a drug under a 
prescription executed in accordance with section 503(b) of the act;
    (7) The distribution of drug samples by manufacturers' and 
authorized distributors' representatives;
    (8) The sale, purchase, or trade of blood or blood components 
intended for transfusion;
    (9) Drug returns, when conducted by a hospital, health care entity, 
or charitable institution in accordance with Sec. 203.23; or
    (10) The sale of minimal quantities of drugs by retail pharmacies to 
licensed practitioners for office use.
    (dd)  Wholesale distributor means any person engaged in wholesale 
distribution of prescription drugs, including, but not limited to, 
manufacturers; repackers; own-label distributors; private-label 
distributors; jobbers; brokers; warehouses, including manufacturers' and 
distributors' warehouses, chain drug warehouses, and wholesale drug 
warehouses; independent wholesale drug traders; and retail pharmacies 
that conduct wholesale distributions.

    Effective Date Note: At 64 FR 67756, Dec. 3, 1999, Sec. 203.3 was 
added, effective Dec. 4, 2000. At 65 FR 25639, May 3, 2000, the 
effective date for Sec. 203.3(u) was delayed until Oct. 1, 2001. At 66 
FR 12851, Mar. 1, 2001, Sec. 203.3(u) was further delayed until Apr. 1, 
2002. At 67 FR 6646, Feb. 13, 2002, the effective date was further 
delayed until Apr. 1, 2003. At 68 FR 4912, Jan. 31, 2003, the effective 
date was further delayed until Apr. 1, 2004. At 69 FR 8105, Feb. 23, 
2004, the effective date of Sec. 203.3(u) was further delayed until 
Dec. 1, 2006.

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