[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: 21CFR203.3]
[Page 101.103]
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:
(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
[[Page 102]]
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 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
[[Page 103]]
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.
[64 FR 67756, Dec. 3, 1999]
Back to Top
© 2007 Betterchem Corp.
|
