[Federal Register Volume 63, Number 234 (Monday, December 7, 1998)]
[Rules and Regulations]
[Pages 67399-67400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32391]



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 Rules and Regulations
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  Federal Register / Vol. 63, No. 234 / Monday, December 7, 1998 / 
Rules and Regulations  

[[Page 67399]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 78N-036L]

RIN 0910-AA01


Drug Labeling; Warning and Direction Statements for Rectal Sodium 
Phosphates for Over-the-Counter Laxative Use; Final Rule; Stay of 
Compliance

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; stay of compliance.

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SUMMARY: The Food and Drug Administration (FDA) is staying compliance 
for the regulation for warning and direction statements for over-the-
counter (OTC) dibasic sodium phosphate/monobasic sodium phosphate 
(sodium phosphates) drug products intended for rectal (enema) use until 
December 7, 1998. The regulation established conditions under which the 
labeling must include warning and direction statements for oral and 
rectal sodium phosphates products. This stay of compliance applies only 
to rectal sodium phosphates products and is in response to requests and 
a citizen petition that the final rule did not allow sufficient time 
for relabeling of these products. This final rule is part of the 
ongoing review of OTC drug products conducted by FDA.

DATES: Section 201.307(b)(2)(ii) and (b)(3)(i) published on May 21, 
1998 (63 FR 27836), are effective September 18, 1998, however, 
compliance with Sec. 201.307(b)(2)(ii) and (b)(3)(i) as they relate to 
rectal sodium phosphates products is not mandatory until December 7, 
1998.

FOR FURTHER INFORMATION CONTACT: Cheryl A. Turner, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2291.

SUPPLEMENTARY INFORMATION:

I. Background

     In the Federal Register of March 31, 1994 (59 FR 15139), the 
agency proposed to amend the tentative final monograph for over-the-
counter (OTC) laxative drug products to limit the OTC container size 
for sodium phosphates oral solution to not greater than 90 milliliters 
(mL). The agency also proposed a warning for all sodium phosphates 
products not to exceed the recommended dosage unless directed by a 
doctor.
     In the Federal Register of May 21, 1998 (63 FR 27836), FDA issued 
a final rule for OTC laxative drug products containing sodium 
phosphates Sec. 201.307(b)(1), (b)(2), and (b)(3) (21 CFR 
201.307(b)(1), (b)(2), and (b)(3)) establishing a container size 
limitation of 90 mL for oral sodium phosphates (sodium phosphates oral 
solution), and new warning and direction statements for OTC oral and 
rectal sodium phosphates for relief of occasional constipation, or for 
preparing the colon for x-ray or endoscopic examination. On May 21, 
1998 (63 FR 27886), FDA also issued a proposed rule to amend the 
tentative final monograph for OTC laxative drug products (21 CFR 334.16 
and 334.58) to include additional general labeling and professional 
labeling for oral and rectal sodium phosphates and a new time-to-effect 
statement for rectal products.
    The final rule requires manufacturers to add certain new labeling 
for rectal sodium phosphates drug products. The new warning in 
Sec. 201.307(b)(2)(ii) states: ``Using more than one enema in 24 hours 
can be harmful.'' The new directions in Sec. 201.307(b)(3)(i) state: 
``Do not'' (``take'' or ``use'') ``more unless directed by a doctor. 
See Warnings.'' The final rule specified an effective date of September 
18, 1998, for these warning and direction statements for rectal sodium 
phosphates products.
    In the final rule (63 FR 27836 at 27842), the agency stated that 
relabeling costs of the type required by this final rule generally 
average about $2,000 to $3,000 per stock keeping unit (SKU) (individual 
products, packages, and sizes). At that time, the agency was aware of 
three manufacturers that together produce approximately 125 SKU's of 
rectal sodium phosphates drug products. The agency mentioned that there 
may be a few additional small manufacturers or a few additional 
products in the marketplace that are not identified in the sources FDA 
reviewed. The agency stated that some entities, especially those 
private label manufacturers that provide labeling for a number of the 
affected products, may incur significant impacts (63 FR 27836 at 
27843).
    In response to the final rule, the agency received two comments 
(Refs. 1 and 2) and two citizen petitions (Ref. 3). One private label 
manufacturer (Ref. 1) stated that the economic impact of the final rule 
was severe because it currently had 126 SKU's of rectal sodium 
phosphates products. The manufacturer stated that its relabeling cost 
was approximately $3,500 per SKU or $441,000. In addition, the cost of 
stickering the current inventory of 2 million printed folding cartons 
is $160,000 with a capital expenditure of $25,000. The cost of 
obsolescence for unused printed folding cartons during the transition 
period was estimated to be $100,000, making total costs approximately 
$776,000. The manufacturer requested that the implementation date of 
the final rule for enema products be 1 year after its effective date. A 
major manufacturer of oral and rectal sodium phosphates products (Ref. 
2) objected to the content of the final rule and argued that the new 
warning and direction statements were not justified for rectal sodium 
phosphates products.
    On July 15, 1998, at a public meeting between representatives of 
FDA and industry (Ref. 4), industry representatives stated the 
following concerns: (1) The warning in Sec. 201.307(b)(2)(ii) would be 
confusing for consumers because it may conflict with how some 
physicians prescribe rectal sodium phosphates for cleansing the bowel 
in preparation for a medical procedure, and (2) 120 days is not enough 
time for manufacturers to relabel their rectal sodium phosphates 
products. Industry representatives suggested that the agency revise the 
warning to read: ``Use only one enema in 24 hours unless recommended by 
a doctor. Serious side effects may occur from excess dosage.'' No 
revisions were

[[Page 67400]]

suggested for the direction statement in Sec. 201.307(b)(3)(i).
    Petitions (Ref. 3) for a ``stay of action and reconsideration'' for 
OTC enemas containing sodium phosphates, submitted in response to this 
meeting, requested: (1) An indefinite stay of the warning and 
directions required by Sec. 201.307(b)(2)(ii) and (b)(3)(i), (2) 
revision of the warning in Sec. 201.307(b)(2)(ii) to read: ``Do not use 
more than one enema in a 24-hour period unless directed by a doctor,'' 
and (3) revision of the directions in Sec. 201.307(b)(3)(i) to read: 
``Use only single daily dose unless directed by a doctor. See 
Warnings.''

 II. The Agency's Response

    The agency acknowledged in its analysis of impacts in the final 
rule (63 FR 27836 at 27842) that private label manufacturers that 
provide labeling for a number of the affected products may incur 
significant impacts. Based on the comment's information (Ref. 1), the 
agency agrees that the economic impact for this specific manufacturer 
is high. In addition, other industry representatives concurred that 120 
days was insufficient time for manufacturers to relabel their rectal 
sodium phosphates products. Therefore, the agency is staying compliance 
with the regulation for relabeling of rectal sodium phosphates products 
until December 7, 1998, to provide manufacturers additional time to 
comply with the labeling requirements of the final rule. Industry was 
previously informed of this stay of compliance with the regulation 
(Ref. 5). The agency is not granting a longer stay of compliance or an 
indefinite stay of compliance of this portion of the final rule because 
of the safety concerns discussed in the final rule (63 FR 27836 at 
27840 to 27841).
    The petitioner's request for reconsideration and revision of the 
warning and direction statements based on professional uses of these 
products is denied (Ref. 5). The warning in the March 31, 1994, 
proposed rule (59 FR 15139 at 15142) was intended to promote the safe, 
direct consumer use of these products. The agency considers the warning 
in Sec. 201.307(b)(2)(ii) and the directions in Sec. 201.307(b)(3)(i) 
in the May 21, 1998, final rule consistent with the safe, direct 
consumer use of rectal sodium phosphates products as intended in the 
proposed rule. The agency may reconsider the wording in this labeling 
if convincing data are submitted that demonstrate consumer confusion. 
The agency believes that professional labeling for these products, 
which will be reproposed in a future issue of the Federal Register, 
will address any remaining labeling concerns.
    Publication of this document constitutes final action on the 
warning and labeling directions for rectal sodium phosphates products 
in Sec. 201.307(b)(2)(ii) and (b)(3)(i) under the Administrative 
Procedure Act (5 U.S.C. 553). Because this final rule is a stay of 
compliance of the regulation, FDA finds that the notice and comment 
procedures are unnecessary and not in the public interest (5 U.S.C. 
553(b) and (d)). The agency believes that staying compliance with the 
regulation, as it relates to rectal sodium phosphates products, until 
December 7, 1998, will provide sufficient time for industry to 
implement the labeling revisions required for rectal sodium phosphates 
products.

 III. References

     The following references are on display in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852, and may be seen by interested parties 
between 9 a.m. and 4 p.m., Monday through Friday.
     1. Comment No. C190, Docket No. 78N-036L, Dockets Management 
Branch.
     2. Comment No. LET176, Docket No. 78N-036L, Dockets Management 
Branch.
     3. Comment No. PRC1, Docket No. 78N-036L, Dockets Management 
Branch.
     4. Comment No. MM16, Docket No. 78N-036L, Dockets Management 
Branch.
     5. Letter from D. Bowen, FDA, to P. Reichertz, Arent Fox 
Kintner Plotkin & Kahn, coded LET178, Docket No. 78N-036L, Dockets 
Management Branch.

 IV. Analysis of Impacts

     The economic impact of the final regulation was discussed in the 
final rule (63 FR 27836 at 27842 and 27843). A stay of compliance for 
the warning and direction statements for rectal sodium phosphates 
products will provide additional time for companies to relabel these 
products and will reduce label obsolescence, as there will be 
additional time to use up more existing labeling. Thus, this final rule 
granting a stay of compliance should reduce the economic impact on 
industry.
    FDA has examined the impacts of the final rule (stay of compliance) 
under Executive Order 12866 and the Regulatory Flexibility Act (5 
U.S.C. 601-612). 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). The agency believes that this final rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the 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.
     The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. This final rule provides a stay of compliance, which 
will provide manufacturers additional time to use up existing product 
labeling. Accordingly, the agency certifies that the 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.

 V. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirements in this document are 
not subject to review by the Office of Management and Budget because 
they do not constitute a ``collection of information'' under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the 
labeling is a ``public disclosure of information originally supplied by 
the Federal Government to the recipient for the purpose of disclosure 
to the public'' (5 CFR 1320.3(c)(2)).

 VI. Environmental Impact

    The agency has determined under 21 CFR 25.31(c) 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.

    Dated: December 1, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-32391 Filed 12-4-98; 8:45 am]
BILLING CODE 4160-01-F