[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.132]

[Page 127-128]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                Subpart G--Packaging and Labeling Control
 
Sec. 211.132  Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    (a) General. The Food and Drug Administration has the authority 
under the Federal Food, Drug, and Cosmetic Act (the act) to establish a 
uniform national requirement for tamper-evident packaging of OTC drug 
products that will improve the security of OTC drug packaging and help 
assure the safety and effectiveness of OTC drug products. An OTC drug 
product (except a dermatological, dentifrice, insulin, or lozenge 
product) for retail sale that is not packaged in a tamper-resistant 
package or that is not properly labeled under this section is 
adulterated under section 501 of the act or misbranded under section 502 
of the act, or both.
    (b) Requirements for tamper-evident package. (1) Each manufacturer 
and packer who packages an OTC drug product (except a dermatological, 
dentifrice, insulin, or lozenge product) for retail sale shall package 
the product in a tamper-evident package, if this product is accessible 
to the public while held for sale. A tamper-evident package is one 
having one or more indicators or barriers to entry which, if breached or 
missing, can reasonably be expected to provide visible evidence to 
consumers that tampering has occurred. To reduce the likelihood of 
successful tampering and to increase the likelihood that consumers will 
discover if a product has been tampered with, the package is required to 
be distinctive by design or by the use of one or more indicators or 
barriers to entry that employ an identifying characteristic (e.g., a 
pattern, name, registered trademark, logo, or picture). For purposes of 
this section, the term ``distinctive by design'' means the packaging 
cannot be duplicated with commonly available materials or through 
commonly available processes. A tamper-evident package may involve an 
immediate-container and closure system or secondary-container or carton 
system or any combination of systems intended to provide a visual 
indication of package integrity. The tamper-evident feature shall be 
designed to and shall remain intact when handled in a reasonable manner 
during manufacture, distribution, and retail display.
    (2) In addition to the tamper-evident packaging feature described in 
paragraph (b)(1) of this section, any two-piece, hard gelatin capsule 
covered by this section must be sealed using an acceptable tamper-
evident technology.
    (c) Labeling. (1) In order to alert consumers to the specific 
tamper-evident feature(s) used, each retail package of an OTC drug 
product covered by this section (except ammonia inhalant in crushable 
glass ampules, containers of compressed medical oxygen, or aerosol 
products that depend upon the power of a liquefied or compressed gas to 
expel the contents from the container) is required to bear a statement 
that:
    (i) Identifies all tamper-evident feature(s) and any capsule sealing 
technologies used to comply with paragraph (b) of this section;
    (ii) Is prominently placed on the package; and
    (iii) Is so placed that it will be unaffected if the tamper-evident 
feature of the package is breached or missing.
    (2) If the tamper-evident feature chosen to meet the requirements in 
paragraph (b) of this section uses an identifying characteristic, that 
characteristic is required to be referred to in the labeling statement. 
For example, the labeling statement on a bottle with a shrink band could 
say ``For your protection, this bottle has an imprinted seal around the 
neck.''
    (d) Request for exemptions from packaging and labeling requirements. 
A manufacturer or packer may request an exemption from the packaging and 
labeling requirements of this section. A request for an exemption is 
required to be submitted in the form of a citizen petition under 
Sec. 10.30 of this chapter and should be clearly identified on the 
envelope as a ``Request for Exemption from the Tamper-Evident Packaging

[[Page 128]]

Rule.'' The petition is required to contain the following:
    (1) The name of the drug product or, if the petition seeks an 
exemption for a drug class, the name of the drug class, and a list of 
products within that class.
    (2) The reasons that the drug product's compliance with the tamper-
evident packaging or labeling requirements of this section is 
unnecessary or cannot be achieved.
    (3) A description of alternative steps that are available, or that 
the petitioner has already taken, to reduce the likelihood that the 
product or drug class will be the subject of malicious adulteration.
    (4) Other information justifying an exemption.
    (e) OTC drug products subject to approved new drug applications. 
Holders of approved new drug applications for OTC drug products are 
required under Sec. 314.70 of this chapter to provide the agency with 
notification of changes in packaging and labeling to comply with the 
requirements of this section. Changes in packaging and labeling required 
by this regulation may be made before FDA approval, as provided under 
Sec. 314.70(c) of this chapter. Manufacturing changes by which capsules 
are to be sealed require prior FDA approval under Sec. 314.70(b) of this 
chapter.
    (f) Poison Prevention Packaging Act of 1970. This section does not 
affect any requirements for ``special packaging'' as defined under 
Sec. 310.3(l) of this chapter and required under the Poison Prevention 
Packaging Act of 1970.

(Approved by the Office of Management and Budget under OMB control 
number 0910-0149)

[54 FR 5228, Feb. 2, 1989, as amended at 63 FR 59470, Nov. 4, 1998]