[Federal Register Volume 59, Number 11 (Tuesday, January 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1049]
[[Page Unknown]]
[Federal Register: January 18, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 211
[Docket No. 92N-0314]
Tamper-Evident Packaging Requirements for Over-The-Counter Human
Drug Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its tamper-resistant packaging requirements to require that all over-
the-counter (OTC) human drug products marketed in two-piece, hard
gelatin capsules be sealed. This proposal follows continuing tampering
incidents involving two-piece, hard gelatin capsules. The agency is
also proposing a change in terminology throughout its regulatory
program from ``tamper-resistant`` to ``tamper-evident.`` In addition,
FDA is soliciting comments on whether additional regulatory changes,
such as packaging performance standards, may be necessary. These
proposed amendments are part of the agency's continuing review of the
potential public health threat posed by product tampering and are meant
to address specific vulnerabilities in the OTC drug market and to
improve consumer protection.
DATES: Written comments by March 21, 1994. FDA proposes that any final
rule that may issue based on this proposal have an initial effective
date of 1 year after its date of publication in the Federal Register.
All OTC drug products marketed in two-piece, hard gelatin capsules that
are initially introduced or initially delivered for introduction into
interstate commerce on or after this date must be sealed according to
the requirements of the final rule. In addition, FDA proposes a retail
level effective date of 2 years after the date of publication of a
final rule in the Federal Register. All two-piece, hard gelatin
capsules subject to the final rule, including products held for sale at
the retail level, must be sealed in compliance with these requirements
by this date or be subject to regulatory action. FDA also proposes that
any labeling changes necessary to reflect the adoption of ``tamper
evident`` terminology be made effective 2 years after the date of
publication of a final rule in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Howard P. Muller, Center for Drug
Evaluation and Research (HFD-362), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-295-8049.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is proposing to amend its tamper-resistant packaging regulation
for OTC drug products in Sec. 211.132 (21 CFR 211.132). The regulation
requires that all OTC drug products (except dermatologics, dentifrices,
insulin, and throat lozenges) be in packaging designed to provide
consumers with visible evidence of any tampering that has occurred. FDA
first adopted these requirements in 1982 to respond to the public
health emergency in which seven persons in the Chicago area died after
taking cyanide-laced Extra-Strength Tylenol capsules (47 FR 50442,
November 5, 1982). Investigations showed that the cyanide had been
intentionally introduced into the capsules after they had reached the
retail shelf. Although the product's packaging met all FDA requirements
at the time, it was not designed so that tampering would leave visible
evidence. The poisoning fatalities illustrated the risk that consumers
of OTC drugs faced without such protective packaging. FDA met with
industry experts to explore ways to reduce this risk and to develop
specific recommendations for OTC drug packaging designs that would make
malicious tampering more obvious. These recommendations formed the
basis of the agency's initial regulatory approach.
The 1982 regulation required that most OTC drug products be
packaged in a tamper-resistant package, which was defined in
Sec. 211.132(b) as packaging having an indicator or a barrier to entry
that could reasonably be expected to provide visible evidence to
consumers that tampering had occurred. In addition to meeting this
general standard, Sec. 211.132(b) required that the tamper-resistant
feature be distinctive by design or use a barrier to entry that
employed an identifying characteristic such as a logo. The regulation
further required that OTC product labeling alert consumers to the
specific packaging feature being employed (Sec. 211.132(c)). All
requirements of this regulation were in effect by February 6, 1984.
FDA continued to monitor the effectiveness of its regulatory
program and found that, while the program had resulted in significant
improvements in protecting consumers from tampering harm, OTC products
marketed in two-piece, hard gelatin capsules remained vulnerable to
malicious tampering. In fact, all known fatalities from contaminated
OTC drugs, including three deaths in 1986--4 years after the tamper-
resistant packaging requirements were first imposed--were associated
with this dosage form.
Recognizing the persistent vulnerability of the hard capsule, the
agency amended its tamper-resistant packaging regulation in the Federal
Register of February 2, 1989 (54 FR 5227), to require that OTC products
marketed in two-piece, hard gelatin capsules be packaged using at least
two tamper-resistant features, unless the capsules were sealed using a
tamper-resistant technology (Sec. 211.132(b)(1) and (b)(2)). FDA
concluded that an additional packaging feature would reduce the dangers
posed by OTC drug tampering by making it more likely that the consumer
would see signs of tampering when it occurred. This requirement went
into effect on February 2, 1990.
Even with this extra level of regulatory protection, two-piece,
hard gelatin capsules remain vulnerable to malicious tampering and have
been implicated in the latest fatalities. In February 1991, two persons
in the State of Washington died and another became gravely ill after
ingesting counterfeit Sudafed capsules contaminated with cyanide. The
capsules had been packaged using a number of tamper-resistant packaging
features that met FDA requirements. The tampering was crudely done and
left obvious signs: while both the counterfeit product and the Sudafed
product were in two-piece, hard gelatin capsules, the counterfeit
capsules were larger than the legitimate Sudafed capsules, lacked the
company logo and ``Sudafed`` imprint, and lacked the blue gelatin band
found on Sudafed capsules. In addition, the foil backing on the
package's blister card had been cut, and lot numbers on the blister
card did not match those on the carton. The contaminated capsules also
contained a yellowish powder, rather than the white granules contained
in Sudafed capsules.
The Sudafed package and dosage form met FDA's tamper-resistant
standard, providing visible signs of tampering that were both numerous
and conspicuous. The fact that physical harm from the tampering
nonetheless occurred was of concern, and illustrated the need for a
renewed focus on consumer education and involvement in the
effectiveness of tamper-resistant or tamper-evident packaging. In
response to this most recent incident, the agency convened a task force
to review existing regulatory strategies and to consider what further
steps could be taken. The task force also considered information
provided by outside experts, including packaging scientists and
representatives of drug manufacturing trade associations. A number of
options were discussed, including banning the use of two-piece, hard
gelatin capsules for OTC drug products or restricting their
availability by requiring that they be kept behind the pharmacy
counter. These discussions balanced the value of the hard capsule
dosage form to consumers against its continued vulnerability to
malicious tampering. Memoranda from these discussions are on display in
the Dockets Management Branch (address above) and are available for
inspection between 9 a.m. and 4 p.m., Monday through Friday.
During these discussions, FDA gave serious consideration to banning
the use of two-piece, hard gelatin capsules, but has tentatively
concluded that such capsules should remain available for several
reasons. First, FDA believes that banning hard gelatin capsules because
they have been associated with tampering may give consumers a false
sense of security that tampering with other dosage forms could no
longer occur. Second, FDA believes that a ban would deprive the public
of a useful dosage form. The Nonprescription Drug Manufacturers
Association (NDMA)\1\ indicated that the two-piece, hard gelatin
capsule can have certain features not provided by other dosage forms
that are currently available. For example, many consumers prefer to
take capsules, finding them easiest to swallow. In addition, some
medications can only be formulated in the capsule dosage form, due to
detrimental effects on active ingredients from tableting or other
formulation processes. Hard gelatin capsules also may contain fewer
inactive ingredients, which can cause allergic reactions in some
individuals, than some tablet and oral liquid formulations. Moreover,
the hard gelatin capsule dosage form is sometimes necessary to deliver
timed-release medications. Given the potential benefits of capsules,
FDA believes that, at this time, it is appropriate to seek to decrease
the risks posed by product tampering through means other than banning
two-piece, hard gelatin capsules.
---------------------------------------------------------------------------
\1\The NDMA position statement entitled ``The Sale of OTC
Medicines in Capsule Form Should Not Be Banned or Restricted'' is on
display in the Dockets Management Branch (address above) and is
available for inspection between 9 a.m. and 4 p.m., Monday through
Friday.
---------------------------------------------------------------------------
This proposed rule is based on investigations and discussions
surrounding the 1991 tampering fatalities, as well as FDA's ongoing
review of the public health threat from OTC drug product tampering. The
proposal suggests some specific regulatory measures for reducing the
potential for tampering with the vulnerable hard capsule dosage form.
It also presents additional ideas for improving the effectiveness of
current policies directed against product tampering and invites public
discussion and comment on these ideas. By proposing the regulatory
changes and encouraging a dialogue on the subject of improving anti-
tampering measures and involvement of the consumer, the agency hopes to
increase protection of the public against malicious tampering.
A. Description of the Proposed Rule
FDA is proposing to amend its tamper-resistant packaging regulation
to decrease the potential for harm from tampering involving two-piece,
hard gelatin capsules. FDA also proposes to take certain steps to focus
the attention of all parties on the need to make consumers aware of the
special packaging features that indicate that tampering has occurred.
The proposed changes complement a number of other actions that FDA is
taking both to improve consumer awareness and to encourage the
development of better packaging technologies.
One proposed change would amend the current regulation that
establishes specific requirements for OTC products marketed in two-
piece, hard gelatin capsules. As noted, this dosage form has been
subject to the most serious tampering incidents over the years. The
regulation now requires that these products be packaged using a minimum
of two tamper-resistant packaging features, unless the capsules are
sealed by a tamper-resistant technology, in which case, one packaging
feature is sufficient (Sec. 211.132(b)(1) and (b)(2)). Proposed
revisions to Sec. 211.132(b)(2) would require that any OTC drug product
marketed in a two-piece, hard gelatin capsule be sealed using a
technology that would provide evidence that the capsule has been
tampered with after filling. (Some capsule sealing technologies are
described in FDA's Compliance Policy Guide 7132a.17.\2\) The proposed
rule would no longer require that such products be packaged in a
container with two tamper-resistant packaging features. The proposed
rule would require that the sealed capsules be in packaging employing a
minimum of one tamper-resistant feature, the requirement that applies
to all other affected OTC dosage forms. The agency believes that
requiring OTC capsules to be sealed may decrease the likelihood that
successful product tampering will occur with this dosage form. This
proposed change would not apply to one-piece, soft gelatin capsules,
also known as soft gels. FDA specifically requests comments on whether
the proposed requirement to seal all two-piece, hard gelatin capsules
would adversely affect any patient population or specific drug entity
or drug class.
---------------------------------------------------------------------------
\2\Compliance Policy Guide 7132a.17 is available from the
National Technical Information Service (NTIS), United States
Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161,
703-487-4650.
---------------------------------------------------------------------------
The agency is also proposing that the term used to describe the
packaging requirements be changed from ``tamper-resistant'' to
``tamper-evident.'' FDA believes that the term ``tamper-evident'' more
accurately describes the role of packaging in reducing the likelihood
of harm from tampering, and emphasizes the necessity of consumer
involvement in the effectiveness of any packaging system designed to
meet the requirements of the regulation.
The change in terminology is intended to underscore the view that
no package design is tamper-proof. The packaging of the Sudafed
capsules did not prevent the 1991 tampering incidents, although it met
FDA requirements and the evidence of tampering was strikingly visible.
The proposed adoption of ``tamper-evident'' terminology should remind
all parties that the success of these regulatory initiatives depends
significantly on consumer vigilance. The proposed rule would also
revise Sec. 211.132(c) to clarify the requirements for the tamper-
evident packaging labeling statement. By alerting consumers to the
particular tamper-evident packaging features used, the labeling
statement plays a crucial role in the effectiveness of any tamper-
evident packaging system. Consumers who are alerted and aware of all
packaging features used are in the best position to detect the evidence
of tampering that the package has been designed to provide.
Current Sec. 211.132(c) states that each retail package ``* * * is
required to bear a statement that is prominently placed so that
consumers are alerted to the specific tamper-resistant feature of the
package.'' Some firms have interpreted this as requiring the labeling
statement to refer only to tamper-evident features on the external
package. Proposed Sec. 211.132(c) would clarify that, in order to alert
consumers to the tamper-evident packaging features used, the labeling
statement must identify all packaging features used to comply with
proposed Sec. 211.132(b)(1), including those on the secondary package,
those on the immediate container or closure, and any capsule sealing
technologies that are employed to meet the requirements of proposed
Sec. 211.132(b)(2).
The proposed rule would also revise Sec. 211.132(b) and (c) to
remove reference to OTC products in aerosol containers, which are
inherently resistant to tampering, but not appropriately considered in
a discussion of tamper-evident packaging.
The proposed rule would also amend Sec. 211.132(a) and (b) to
replace the term ``throat lozenge'' with ``lozenge.'' FDA is making
this change because the tamper-evident packaging requirements should
apply to all lozenges, not just throat lozenges. The agency also notes
that the proposed change is consistent with earlier tamper-resistant
packaging regulations (see 48 FR 16658 at 16664, April 19, 1983).
B. Legal Authority
This proposal is authorized in part by sections of the Federal
Food, Drug, and Cosmetic Act (the act) concerning imposition of
requirements necessary to assure that drugs meet the requirements of
the act for identity, strength, quality, and purity. These requirements
may be imposed as current good manufacturing practice under section
501(a)(2)(B) of the act (21 U.S.C. 351(a)(2)(B)) and in aid of other
statutory requirements relating to product safety and integrity. (See,
e.g., 21 U.S.C. 351(b) and (c) and section 701 (21 U.S.C. 371(a)) of
the act.) This statutory authorization permits promulgation of
requirements for container and package design that provide protection
against intentional product adulteration by means of tampering.
Promulgating requirements for labeling statements alerting drug
product consumers to tamper-evident features is authorized under the
adulteration provisions in section 501 and under the provisions in
sections 502 and 201(n) of the act (21 U.S.C. 352(c) and 321(n)). The
labeling statements are necessary to assure the effectiveness of the
tamper-evident features; without such statements the products would be
adulterated. In addition, under section 502(c) of the act, products are
misbranded if statements required under other authority in the act are
omitted from the products' labeling. Moreover, under sections 201(n)
and 502(a) of the act, products may be misbranded by reason of the
omission of material facts about the products, such as the tamper-
evident features. (See 47 FR 50442 at 50447, November 5, 1982, for
additional discussion of the legal authority for requirements related
to drug product tampering.)
II. Other Consumer Protection Initiatives
A. Consumer Education
The 1991 tampering fatalities made clear that the OTC drug supply
is still vulnerable to malicious tampering. As noted, FDA's
deliberations following these fatalities focused on reevaluating
current strategies to reduce the likelihood of harm from tampering and
looking at the role that FDA, industry, and consumers play in their
success or failure. While the agency will consider whether additional
changes to the regulations may be needed to reduce the risks posed by
product tampering, FDA believes that further initiatives will
increasingly focus on consumer education and involvement.
FDA has already taken steps to inform consumers about the need to
be alert for drug product tampering. FDA has worked closely with NDMA
to develop and disseminate public service announcements about
tampering. These are being provided to general circulation magazines
and other publications. In addition, the October 1991 issue of FDA
Consumer contained an article entitled ``Look Twice,'' which explains
the danger posed by drug product tampering and the need for consumer
vigilance. Similar information appears in materials cosponsored by FDA
and NDMA including a brochure called ``Buying Medicine?: Stop, Look,
Look Again'' and a video and audio tape on product tampering entitled
``Take A Look,'' which has been distributed to the media. FDA is also
considering sponsoring workshops around the country to inform the
public about tamper-evident packaging and the safety of the OTC drug
supply. FDA solicits comments and suggestions from the public on ways
to improve this educational campaign.
B. Research Into Consumer Behavior
The regulatory strategies FDA has adopted have been based on
certain assumptions about how consumers behave when buying and taking
their OTC drug products. To choose the most effective measures to
enable consumers to detect tampering, it is necessary to have more and
better information about how consumers select, purchase, and use OTC
drug products and how tamper-evident packaging and associated labeling
affects their behavior. FDA is aware of some research in this area,
including studies done at Michigan State University, Rutgers
University, and other academic institutions. Although such research has
provided useful starting points for discussions of tamper-evident
packaging, FDA believes that further research is needed to permit the
design of more effective packaging features and educational campaigns.
FDA is interested in learning more about any current consumer research
that is relevant to the concerns of this rulemaking. FDA is also
willing to assist any industry group or other interested party in the
design and development of research in this area.
C. Private Initiatives
As noted, the agency has taken several steps to encourage the use
of safer packaging technologies. FDA believes that these steps can be
complemented by actions of drug manufacturers and other interested
persons. The agency initiatives in 1982 were taken with the knowledge
that certain packaging technologies, including, for example, film
wrappers, blister or strip packs, and heat shrink bands or wrappers,
were available to drug manufacturers to reduce the risk of tampering.
The agency notes that few new technologies have been added since 1982.
The agency recognizes that no package is tamper-proof but believes that
there are opportunities for innovations and for refinement of current
designs to improve consumer protection. FDA encourages both individual
and collective efforts in the OTC drug and packaging industry to devise
better technologies.
FDA would also like to discuss with the drug industry and other
interested persons the possibility of establishing performance
standards for tamper-evident packaging. Such standards might be based
on the probability that a consumer could detect evidence of tampering
with a given packaging design. Compliance with the standards might be
measured by studying the likelihood that a consumer would recognize
signs of tampering within a specified amount of time. Where a packaging
feature is to be used on a product targeted to or frequently purchased
by a particular group of consumers, such as the elderly, the level of
recognition might be determined using a representative number of the
particular group.
Developing performance standards based, in part, on the behavior
and reaction of consumers to product packaging would be challenging.
FDA believes, however, that it is not an impossible task, and suggests
that information from the research and development of package design
from a marketing standpoint might be useful. Furthermore, the agency
believes that any performance standards for tamper-evident packaging
should be based on the latest behavioral and technological information
available. Such state-of-the-art standards would give packaging
engineers and manufacturers a benchmark for evaluating particular
package designs, and would provide an incentive to improve the
effectiveness of tamper-evident packaging to mirror technological
progress in the field. The agency invites comments on the
appropriateness of developing and requiring performance standards for
tamper-evident packaging.
III. Economic Impact
FDA has carefully considered the economic impact of this proposed
rule and has determined that it requires neither a regulatory impact
analysis, as specified by Executive Order 12291, nor a regulatory
flexibility analysis, as defined in the Regulatory Flexibility Act
(Pub. L. 96-354). The agency believes that the proposed rule, if
finalized, would generate costs that are well below the thresholds that
would signify a major rule, and so the proposed rule does not require a
regulatory impact analysis. The agency also finds that the proposed
rule would not have a significant effect on a substantial number of
small entities, and therefore does not require a regulatory flexibility
analysis.
Current FDA requirements for OTC drug packaging to protect the
public from the threat of product tampering have been in place since
1982. This proposed rule would not change the scope or applicability of
these requirements, but would only amend the requirements with regard
to one OTC drug dosage form and impose a minor labeling change that
would affect certain products.
This proposed rule may impose additional costs on manufacturers who
choose to market their OTC drug products in two-piece, hard gelatin
capsules instead of switching to a different dosage form, such as a
soft-gel or liquid-gel capsule, or a caplet. The proposed rule would
delete the current requirement that two-piece, hard gelatin capsules be
packaged using two tamper-evident features, and would require instead
that all such capsules be sealed and packaged using at least one
tamper-evident feature. FDA believes that capsule sealing would make it
more difficult to tamper with this dosage form without leaving visible
evidence, and that any costs resulting from the rule would be small
compared to public health benefits from this added measure of consumer
protection.
The number of two-piece, hard gelatin capsule OTC products sold
over the last few years has declined dramatically, with fewer than 50
such items currently listed with FDA. A review of those products
indicates that from 75 percent to 90 percent are already sealed or
``banded.'' Thus, FDA is aware of only a small number of OTC products
still marketed as unsealed two-piece, hard gelatin capsules. Under the
proposed rule, the few firms producing these products would have to
choose between incurring costs for reformulating the product to a
different dosage form or installing machinery needed to seal the two-
piece, hard gelatin capsules. The affected firms would not face
substantial added costs for lost product inventory because the proposed
rule allows manufacturers 1 year and retailers 2 years after the date
of publication of a final rule to effect the changes.
NDMA estimates that the approximate cost of a capsule sealing or
banding machine ranges from $150,000 to $250,000. Assuming FDA's higher
bound estimate that only 25 percent of the 50 listed, two-piece, hard
gelatin capsule products are not currently sealed with an appropriate
technology, then 12 products would need to be sealed or banded. If only
one new capsule banding machine were needed per product, the total cost
to the industry would range from $1.8 million to $3 million. An
additional cost may occur if it is difficult for a company to integrate
the sealing equipment into its capsule filling line. According to NDMA,
some companies may find that this problem adds an extra cost of
approximately 50 cents to 80 cents per 1,000 capsules. Nonetheless, for
all but the smallest product lines, these costs would be a modest
percentage of sales. The proposed rule would also change regulatory
terminology from ``tamper-resistant'' packaging to ``tamper-evident''
packaging. This would affect a substantial number of firms because it
would necessitate a labeling change under Sec. 211.132(c) for all OTC
products that now have the words ``tamper-resistant'' on their package.
A small survey conducted by FDA found that approximately 60 percent of
OTC drug product labels include the words ``tamper-resistant.'' The
remaining product labels include a description of tamper-resistant
packaging features, but do not specifically use the words ``tamper-
resistant.''
In 1986, NDMA estimated that about 70 percent of their members'
435 products, excluding private labelers, were affected by tamper-
resistant packaging regulations. On the assumption that there were
three shelf keeping units (SKU's) per product, this amounted to about
1,300 SKU's. Based on a 1986 survey of its members, NDMA had reported
that the average labeling change cost per SKU was $3,000 to $4,000. The
current proposal, however, would require a much simpler label change
than was considered in that 1986 survey. Nonetheless, if the cost per
SKU were assumed to be about $3,000, the total cost of changing 60
percent of these labels would be approximately $2.3 million (60 percent
x 1,300 x $3,000). In addition, NDMA provided a preliminary estimate of
$5 million for 15 larger private labeling companies. Sixty percent of
this cost amounts to $3 million. Thus, the potential upper-bound cost
imposed by the proposed labeling changes may amount to $5 to $6
million.
The actual cost of the labeling change would be significantly
lessened by FDA's proposed effective date for the labeling change,
which would give manufacturers up to 2 years from the date of
publication of a final rule to make the required changes. The agency
chose this timeframe to minimize the burden to industry of converting
to ``tamper-evident'' terminology, based on information from NDMA that
most product labels are routinely reprinted within an 18- to 24-month
period. Thus, although FDA does not know the precise number of OTC
product labels that are normally reprinted within a 2-year period, the
labeling costs attributable to the proposed regulation would be minimal
for most firms in this industry.
To summarize, the total one-time costs of this proposed rule would
be the sum of the approximately $3 million to seal or band the
remaining few two-piece, hard gelatin capsule products and the minimal
costs needed to change the labeling on the products that currently read
``tamper-resistant.''
In addition to these regulatory changes, FDA has invited comments
on other initiatives such as the development of better consumer
education campaigns, research into consumer behavior with regard to OTC
packaging and tamper-evident packaging, and the possibility of
developing performance standards for tamper-evident packaging. Any of
these programs, if adopted as regulatory requirements, could have
significant economic importance. Before promulgating any final
regulation, however, FDA intends to consider all relevant information
on the economic consequences of these initiatives and reasonable
alternatives. The agency solicits public comment on all aspects of both
the costs and feasibility of all issues raised by this proposal,
especially with respect to any impact on affected small businesses.
IV. Executive Order 12612--Federalism
Executive Order 12612 requires that Federal agencies carefully
examine regulatory actions to determine if they would have significant
federalism implications. FDA's tamper-resistant packaging regulations
were issued with the intent that the regulations preempt State and
local packaging requirements that are not identical to the Federal
requirements in all respects (47 FR 50442 at 50447, November 5, 1992).
The agency believes that the proposed changes would improve safeguards
to protect consumers from tampering of all OTC drug products,
particularly those marketed as two-piece, hard gelatin capsules, and
that the amendments, therefore, should eliminate the need for
additional action at the State or local level. FDA invites comments on
the adequacy of the proposed amendments in this regard.
V. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. Request for Comments
Interested persons may, on or before March 21, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
VII. Proposed Effective Dates
FDA proposes that any final rule based on the proposed requirement
that all OTC drug products marketed as two-piece, hard gelatin capsules
be sealed be made effective 1 year after its date of publication in the
Federal Register. All OTC drug products marketed as two-piece, hard
gelatin capsules that are initially introduced or initially delivered
for introduction into interstate commerce on or after the effective
date must be sealed according to the requirements of the final rule or
be subject to regulatory action. FDA also proposes a retail level
effective date for this requirement of 2 years after the date of
publication of a final rule in the Federal Register. After this date,
all two-piece, hard gelatin capsule products held for sale (including
stocks in retail stores) must be sealed according to the requirements
of the final rule or be subject to regulatory action.
FDA also proposes that any labeling changes necessary to reflect
the adoption of ``tamper-evident'' terminology be made within 2 years
after the date of publication of a final rule in the Federal Register.
Based on information from industry, FDA expects that most products
subject to tamper-evident packaging requirements will have undergone
routine labeling revisions within this timeframe.
List of Subjects in 21 CFR Part 211
Drugs, Labeling, Laboratories, Packaging and containers,
Prescription drugs, Reporting and recordkeeping requirements,
Warehouses.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 211 be amended as follows:
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS
1. The authority citation for 21 CFR part 211 continues to read as
follows:
Authority: Secs. 201, 501, 502, 505, 506, 507, 512, 701, 704 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352,
355, 356, 357, 360b, 371, 374).
2. Section 211.132 is amended by revising the section heading, by
removing in paragraph (a) the word ``throat'', by removing in
paragraphs (a) and (d)(2) the words ``tamper-resistant'' and adding in
their place the words ``tamper-evident'', and by revising paragraphs
(b), (c), and the second sentence in the introductory text of paragraph
(d) to read as follows:
Sec. 211.132 Tamper-evident packaging requirements for over-the-
counter (OTC) human drug products.
* * * * *
(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 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 or containers of compressed medical oxygen) 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) * * * 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 Rule.'' * * *
* * * * *
Dated: September 13, 1993.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-1049 Filed 1-14-94; 8:45 am]
BILLING CODE 4160-01-F