[Federal Register Volume 65, Number 119 (Tuesday, June 20, 2000)]
[Rules and Regulations]
[Pages 38191-38194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15427]


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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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

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