65FR38191 Over-the-Counter Human Drugs; Labeling Requirements; Partial Extension of Compliance Dates
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Posting-number: Volume 65, Issue 119, Page 38191
[Federal Register: June 20, 2000 (Volume 65, Number 119)]
[Rules and Regulations]
[Page 38191-38194]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn00-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 330, 331, 341, 346, 355, 358, 369, and 701
[Docket Nos. 98N-0337, 96N-0420, 95N-0259, and 90P-0201]
RIN 0910-AA79
Over-the-Counter Human Drugs; Labeling Requirements; Partial
Extension of Compliance Dates
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; partial extension of compliance dates.
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SUMMARY: The Food and Drug Administration (FDA) is providing a partial
extension of the compliance dates for its final rule that appeared in
the Federal Register of March 17, 1999. The final rule established a
standardized format and standardized content requirements for the
labeling of over-the-counter (OTC) drug products. That final rule
requires all OTC drug products to have the new, easy-to-read format and
the revised labeling requirements within prescribed implementation
periods. This partial extension provides 1 additional year for
implementation for specific types of OTC drug products to be in
compliance with the final rule.
DATES:
Effective Date: This rule is effective July 20, 2000.
Compliance Dates: For compliance dates, see section III of the
SUPPLEMENTARY INFORMATION section of this document. Submit written
comments by September 18, 2000.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug
Evaluation and Research (HFD-560), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2307.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 17, 1999 (64 FR 13254), FDA
published a final rule establishing standardized format and
standardized content requirements for the labeling of OTC drug
products. Those requirements are codified in Sec. 201.66 (21 CFR
201.66).
Section 201.66(a) states that the content and format requirements
in Sec. 201.66 apply to the labeling of all OTC drug products. This
includes products marketed under a final OTC drug monograph, an
approved new drug application (NDA) or abbreviated new drug application
(ANDA) under section 505 of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 355), and OTC drug products for which there is no
final OTC drug monograph or approved drug application.
The agency provided different implementation dates by which OTC
drug products had to be in compliance with the new requirements. These
dates varied according to the regulatory status of the products (64 FR
13254 at 13273 and 13274).
A. Products in the OTC Drug Review
Products marketed under final OTC drug monographs had to comply
with the final rule by April 16, 2001. Products for which a final
monograph became effective on or after April 16, 1999, had to comply as
of: (1) The applicable implementation date for that final monograph;
(2) the next major revision to any part of the label or labeling after
April 16, 2001; or (3) April 18, 2005, whichever occurs first.
Combination drug products in which all of the active ingredients
are the subject of a final monograph or monographs had to comply with
the final rule as of April 16, 2001. Combination products in which one
or more active ingredients are the subject of a final monograph, and
one or more ingredients are still under review as of the effective date
of the final rule, had to comply as of the implementation date for the
last applicable final monograph for the combination, or as of April 16,
2001, whichever is earlier. Combination products in which none of the
active ingredients is the subject of a final monograph or monographs as
of the effective date of the final rule had to comply as of: (1) The
implementation date of the last applicable final monograph for the
combination; (2) the next major revision to any part of the label or
labeling after April 16, 2001; or (3) April 18, 2005, whichever comes
first.
[[Page 38192]]
B. Products Marketed Under NDA's and ANDA's
Products that are the subject of an approved drug application (NDA
or ANDA) before April 16, 1999, had to comply as of April 16, 2001.
Products that become the subject of an approved NDA or ANDA on or after
April 16, 1999, had to immediately comply with the final rule.
C. Additional Provisions
Any OTC drug product that was not described in section I.A and I.B
above had to comply with the final rule as of: (1) The next major
revision to any part of the label or labeling after April 16, 2001; or
(2) April 18, 2005, whichever occurs first.
Products (including combinations) marketed under a final OTC drug
monograph or monographs, or under an NDA or ANDA, with annual sales of
less than $25,000 had to comply with the final rule as of April 16,
2002. This extra time was intended to provide marketed products with a
low level of distribution 1 additional year to comply with the final
rule.
Irrespective of the regulatory status of the product, the agency
strongly encouraged all manufacturers, distributors, and packers of OTC
drug products to voluntarily implement the new content and format
requirements as soon as possible, particularly when existing labeling
is exhausted and relabeling would occur in the normal course of
business. The agency also encouraged sponsors of products marketed
under NDA's and ANDA's to submit any required labeling supplements as
soon as possible to ensure timely review.
The agency provided a chart that summarized the time periods within
which the various categories of marketed OTC drug products must be in
compliance with the final rule (64 FR 13254 at 13274). Unless otherwise
stated, all time periods in the chart began on the effective date of
the final rule.
In the Federal Register of April 15, 1999 (64 FR 18571), the agency
published a correction to the final rule and corrected the effective
date from April 16, 1999, to May 16, 1999. While the agency did not
discuss the implementation plan and the compliance dates for the final
rule (or the chart at 64 FR 13274) in this correction, the correction
had the effect of changing the compliance dates for the final rule: (1)
April 16, 1999, to May 16, 1999; (2) April 16, 2001, to May 16, 2001;
(3) April 16, 2002, to May 16, 2002; and (4) April 18, 2005, to May 16,
2005.
II. Citizen Petitions Requesting Additional Implementation Time
Following publication of the final rule, the Consumer Healthcare
Products Association (CHPA) and The Cosmetic, Toiletry, and Fragrance
Association (CTFA) submitted citizen petitions (Refs. 1 and 2)
requesting a 2-year extension of time for compliance with the final
rule, i.e., extending the May 16, 2001, date to May 16, 2003, and the
May 16, 2002, date to May 16, 2004. No change to the May 16, 2005, date
was requested. CHPA also requested a stay of the final rule for those
products that had to immediately begin to comply with the rule (i.e.,
OTC drug products approved under an NDA or ANDA after May 16, 1999)
until several implementation issues described in the CHPA petition were
resolved and companies were given sufficient time to incorporate FDA's
clarification into OTC drug product labeling. The petitions discussed a
number of issues CHPA and CTFA considered as ``open'' or pending: (1)
The use of columns in labeling, (2) the protection of trade dress, (3)
the use of type sizes smaller than 6.0 points, (4) the labeling of
single use and convenience packages or a categorical small package
exemption, (5) the use of extended text labeling, (6) the exemption
process, and (7) harmonizing the new ``Drug Facts'' labeling with
existing cosmetic labeling.
The agency answered these citizen petitions on February 4, 2000
(Refs. 3 and 4). The agency addressed the issues that were raised and
stated that most of the issues (columns, the exemption process, the
labeling of single use and convenience products) had been addressed or
would soon be addressed through the agency's guidance process. One
issue (trade dress) had been addressed through a recent amendment to
the final rule (65 FR 7, January 3, 2000). The agency did not consider
the remaining issues as presenting a significant obstacle toward
industry-wide implementation of the final rule, as demonstrated by the
large numbers of products that are able to comply with the rule.
III. The Agency's Final Conclusions
The agency concluded that a stay of the final rule or a blanket
extension of 2 years is excessive and is not consistent with the
public's interest in having clear, readable OTC drug product labeling.
Also, recognizing that guidance documents may prove helpful to industry
in the transition to the new labeling format, and that the agency
intends to issue at least one more guidance document (on exemptions and
deferrals), the agency concluded that an extension of the May 16, 2001,
date by 1 year to May 16, 2002 (and a corresponding extension of the
May 16, 2002, date for products with annual sales of less than $25,000
to May 16, 2003) is justified. The request for a stay of the final rule
for products marketed under an NDA or ANDA approved after May 16, 1999,
was denied.
The agency is restating below in table 1, the implementation chart
that appeared in the final rule (64 FR 13254 at 13274). This chart is
updated to show the new implementation compliance dates for the final
rule. In addition, the agency is making one minor change in the
implementation chart. For combination products subject to an OTC drug
monograph or monographs in which at least one applicable monograph was
finalized before May 16, 1999, and at least one applicable monograph is
finalized on or after May 16, 1999, the time period is stated as
``Within the period specified in the last applicable monograph to be
finalized, or by May 16, 2002 (or by May 16, 2003, if annual sales of
the product are less than $25,000), whichever occurs first.'' The
agency recognizes that some final monographs may be finalized close to
the May 16, 2002, date. If that occurred, relabeling might be required
at two closely related time intervals by two different final rules. The
agency would be aware of that possibility when the last applicable
monograph is published and would make allowance there to avoid this
dual relabeling within a short time period. Therefore, the agency is
adding at the end of the time period for this specific type of
combination product in the implementation chart the words ``unless the
last applicable monograph to be finalized specifies a later date.''
This language should alleviate any possible ambiguities that might have
existed as to when relabeling required by two different rules would
have to occur.
[[Page 38193]]
Table 1.--Implementation Chart
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Products Time periods
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Single entity and combination products subject to drug By May 16, 2002 (or by May 16, 2003, if annual sales of
marketing applications approved before May 16, 1999. the product are less than $25,000).
Single entity and combination products subject to drug Immediately upon approval of the application.
marketing applications approved on or after May 16,
1999.
Single entity products subject to an OTC drug monograph By May 16, 2002 (or by May 16, 2003, if annual sales of
finalized before May 16, 1999. the product are less than $25,000).
Single entity products subject to an OTC drug monograph Within the period specified in the final monograph.
finalized on or after May 16, 1999. However, if a monograph has not been finalized as of
May 16, 2002, then the product must comply as of the
first major labeling revision after May 16, 2002, or
by May 16, 2005, whichever occurs first.
Combination products subject to an OTC drug monograph By May 16, 2002 (or by May 16, 2003, if annual sales of
or monographs in which all applicable monographs were the product are less than $25,000).
finalized before May 16, 1999.
Combination products subject to an OTC drug monograph Within the period specified in the last applicable
or monographs in which at least one applicable monograph to be finalized, or by May 16, 2002 (or by
monograph was finalized before May 16, 1999, and at May 16, 2003, if annual sales of the product are less
least one applicable monograph is finalized on or than $25,000), whichever occurs first, unless the last
after May 16, 1999. applicable monograph to be finalized specifies a later
date.
Combination products subject to an OTC drug monograph Within the period specified in the last applicable
or monographs in which all applicable monographs are monograph to be finalized. However, if the last
finalized on or after May 16, 1999. monograph is not finalized as of May 16, 2002, then
the product must comply as of the first major labeling
revision after May 16, 2002, or by May 16, 2005,
whichever occurs first.
All other single entity and combination OTC drug If a monograph has not been finalized as of May 16,
products (e.g., products in the OTC drug review that 2002, then the product must comply as of the first
are not yet the subject of proposed OTC drug major labeling revision after May 16, 2002, or by May
monographs). 16, 2005, whichever occurs first.
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IV. Extension of Compliance Dates for Other Labeling Revisions
The final rule also contained a number of other required labeling
revisions in 21 CFR parts 201, 330, 331, 341, 346, 355, 358, 369, and
701 (64 FR 13254 at 13291, 13292, and 13294 to 13297). For any of those
labeling revisions that would have had to be implemented by May 16,
2001, or May 16, 2002, as a result of complying with Sec. 201.66, the
agency is also providing a 1-year extension of time for implementation.
V. Analysis of Impacts
The economic impact of the final rule was discussed in the final
rule (64 FR 13254 at 13276 to 13285. This partial extension of the
compliance dates provides additional time for companies to relabel
their products and be in compliance with the final rule. This extension
will also reduce label obsolescence as companies will have additional
time to use up more existing labeling. Thus, extending some of the
compliance dates by 1 year will significantly reduce the economic
impact on industry.
FDA has examined the impacts of this final rule (partial extension
of the compliance dates) under Executive Order 12866, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4) (2 U.S.C. 1501 et seq.). Executive Order
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Under the Regulatory
Flexibility Act, if a rule has a significant economic impact on a
substantial number of small entities, an agency must analyze regulatory
options that would minimize any significant impact of the rule on small
entities. Title II of the Unfunded Mandates Reform Act requires that
agencies prepare a written statement and economic analysis before
proposing any rule that may result in an expenditure in any one year by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million (adjusted annually for inflation).
The agency concludes that this final rule is consistent with the
principles set out in the Executive order and in these two statutes.
This final rule is not a significant regulatory action as defined by
the Executive order and so is not subject to review under the Executive
Order. As discussed in this section, FDA has determined that this final
rule will not have a significant economic impact on a substantial
number of small entities. Further, because this final rule makes no
mandates on government entities and will result in expenditures less
than $100 million in any one year, FDA need not prepare additional
analyses under the Unfunded Mandates Reform Act.
The purpose of this final rule is to provide a partial extension of
some of the compliance dates by which manufacturers need to relabel
their products. This final rule provides 1 additional year to relabel
many products. Accordingly, the agency certifies that this final rule
will not have a significant economic impact on a substantial number of
small entities. Therefore, under the Regulatory Flexibility Act, no
further analysis is required.
VI. Good Cause
In its responses to the citizen petitions (Refs. 3 and 4), the
agency set forth in detail its finding that a stay of the rule, or a
blanket extension of 2 years, is excessive and is not consistent with
the public's interest in having clear, readable OTC drug labeling.
However, in recognition of the fact that there are several pending
guidance documents that may prove helpful in the transition to the new
format, and that at least one on exemptions and deferrals has yet to
issue, the agency concluded that an extension of the May 16, 2001,
primary implementation date by 1 year to May 16, 2002 (and the
corresponding implementation date for products with annual sales less
that $25,000 to May 16, 2003) was justified. Since the agency is
extending the compliance date of the OTC labeling final rule based on
the citizen petition responses and because these changes are
nonsubstantive in nature, FDA finds that notice and comment procedures
are
[[Page 38194]]
unnecessary and not in the public interest (5 U.S.C. 553(b) and (d)).
More than 3 months have passed since the agency issued the citizen
petition responses and the agency has received no adverse
correspondence or comments with respect to its decision. Therefore, the
agency is now amending the compliance date of the final rule. However,
in accordance with 21 CFR 10.40(e)(1), FDA is providing an opportunity
for comment on whether this partial extension of the compliance dates
should be modified or revoked.
VII. References
1. Comment No. CP2, Docket No. 98N-0337, Dockets Management Branch.
2. Comment No. CP1, Docket No. 99P-4617, Dockets Management Branch.
3. Letter from W. K. Hubbard, FDA, to B. N. Kuhlik and M. S.
Labson, Covington & Burling, coded PAV2, Docket No. 98N-0337, Dockets
Management Branch.
4. Letter from W. K. Hubbard, FDA, to E. E. Kavanaugh, CTFA, coded
PAV1, Docket No. 99P-4617, Dockets Management Branch.
This final rule (partial extension of compliance dates) is issued
under sections 201, 501, 502, 503, 505, 510, and 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 355, 360,
and 371) and under authority delegated to the Commissioner of Food and
Drugs.
VIII. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments regarding this final rule by September
18, 2000. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket numbers found in brackets in the heading of this document.
Received comments may be seen in the Dockets Management Branch between
9 a.m. and 4 p.m., Monday through Friday.
Dated: June 12, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-15427 Filed 6-19-00; 8:45 am]
BILLING CODE 4160-01-F