[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: 21CFR200.200]
[Page 7-8]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 200 GENERAL--Table of Contents
Subpart E Prescription Drug Consumer Price Listing
Sec. 200.200 Prescription drugs; reminder advertisements and reminder
labeling to provide price information to consumers.
(a) Prescription drug reminder advertisements and reminder labeling
intended to provide price information to consumers are exempt from the
requirements of Sec. Sec. 201 .100 and 202.1 of this chapter if all of
the following conditions are met:
(1) The only purpose of the reminder advertisement or reminder
labeling is to provide consumers with information concerning the price
charged for a prescription for a particular drug product, and the
reminder advertisement or reminder labeling contains no representation
or suggestion concerning the drug product's safety, effectiveness, or
indications for use.
(2) The reminder advertisement or reminder labeling contains the
proprietary name of the drug product, if any; the established (generic)
name of the drug product, if any; the drug product's strength if the
product contains a single active ingredient or if the product contains
more than one active ingredient and a relevant strength can be
[[Page 8]]
associated with the product without indicating each active ingredient
(the established name and quantity of each active ingredient are not
required); the dosage form; and the price charged for a prescription for
a specific quantity of the drug product.
(3) The reminder advertisement or reminder labeling may also include
other written, printed, or graphic matter, e.g., identification of
professional or convenience services provided by the pharmacy: Provided,
That such information is neither false nor misleading and contains no
representation or suggestion concerning the drug product's safety,
effectiveness, or indications for use.
(4) The price stated in the reminder advertisement or reminder
labeling as that charged for a prescription shall include all charges to
the consumer including, but not limited to, the cost of the drug
product, professional fees, and handling fees, if any. Mailing fees and
delivery fees, if any, may be stated separately and without repetition.
(b) This exemption from Sec. Sec. 201.100 and 202.1 of this chapter
is applicable to all prescription drug reminder labeling and reminder
advertisements solely intended to provide consumers with information
regarding the price charged for prescriptions including price lists,
catalogs, and other promotional material, whether mailed, posted in a
pharmacy, placed in a newspaper, or aired on radio or television.
(c) Any reminder advertisement or reminder labeling intended to
provide consumers with prescription price information which is not in
compliance with this section shall be the subject of appropriate
regulatory action. Such action may be taken against the product and/or
the responsible person.
[40 FR 58799, Dec. 18, 1975]
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