[Federal Register Volume 69, Number 228 (Monday, November 29, 2004)]
[Rules and Regulations]
[Pages 69278-69280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 1990N-0309]
RIN 0910-AF50


Drug Labeling; Sodium Labeling for Over-the-Counter Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
amending the regulations for sodium labeling for over-the-counter (OTC) 
drug products by extending the sodium content labeling requirement to

[[Page 69279]]

rectal drug products containing sodium phosphate/sodium biphosphate 
(sodium phosphates). FDA is taking this action because people with 
certain medical conditions are at risk for an electrolyte imbalance to 
occur when using rectal sodium phosphates products. Serious adverse 
events and deaths have occurred because of the high level of sodium 
present in these products. This final rule is part of FDA's ongoing 
review of OTC drug products.

DATES: This rule is effective November 29, 2005.

FOR FURTHER INFORMATION CONTACT: Neel Patel, Center for Drug Evaluation 
and Research (HFD-560), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 24, 2004 (69 FR 13765), FDA issued 
a proposed rule to amend the regulations for sodium labeling for OTC 
drug products to require sodium content labeling for rectal drug 
products containing sodium phosphates. FDA considers it important that 
consumers be aware of the sodium content of OTC rectal drug products 
containing sodium phosphates and that this information appear in 
product labeling so that it will be readily available to consumers, 
physicians, and other health professionals. Some OTC laxative drug 
products intended for rectal administration can contain very high 
levels of sodium from both active and inactive ingredients. Significant 
amounts of some of these products may be absorbed causing an 
electrolyte imbalance.
    Section 201.64 (21 CFR 201.64) requires orally ingested sodium 
phosphates products to bear sodium content information. FDA proposed to 
add paragraph (k) to Sec.  201.64 to require sodium content information 
to appear in the labeling of rectal drug products containing dibasic 
sodium phosphate and/or monobasic sodium phosphate.

II. Final Rule Amending Sodium Labeling Regulations

    FDA did not receive any comments to its proposed new labeling 
requirements, its discussion of the statutory authority to require this 
labeling, or its discussion of this labeling requirement being 
constitutionally permissible under the first amendment. Accordingly, 
FDA is not repeating those discussions in this final rule, but is 
incorporating the discussions regarding statutory authority and the 
first amendment by reference (see 69 FR 13766 to 13767). FDA is 
finalizing its proposal by requiring sodium content information to 
appear in the labeling of OTC rectal drug products containing dibasic 
sodium phosphate and/or monobasic sodium phosphate.

III. Analysis of Impacts

    FDA has examined the impacts of this final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (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. Section 202(a) of the Unfunded Mandates Reform Act of 1995 
requires that agencies prepare a written statement of anticipated costs 
and benefits 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).
    FDA concludes that this final rule is consistent with the 
principles set out in Executive Order 12866 and in these two statutes. 
As discussed in this section of the document, the final rule will not 
be economically significant as defined by the Executive order. With 
respect to the Regulatory Flexibility Act, FDA concludes that the rule 
would not have a significant economic impact on a substantial number of 
small entities. The Unfunded Mandates Reform Act of 1995 does not 
require FDA to prepare a statement of costs and benefits for the final 
rule, because the final rule is not expected to result in any 1-year 
expenditure that would exceed $100 million adjusted for inflation. The 
current inflation adjusted statutory threshold is about $110 million.
    The purpose of this final rule is to extend the requirement for 
sodium content labeling to OTC rectal drug products that contain sodium 
phosphates so that the information is available to: (1) Health 
professionals and (2) individuals who need to limit their sodium 
intake. The final rule would require minor relabeling of OTC rectal 
drug products containing sodium phosphates. There are fewer than five 
major manufacturers of these products in the OTC drug marketplace. One 
company manufactures a nationally branded product with the others 
producing private label products. One large manufacturer produces about 
one-half to two-thirds of the products covered by this final rule. 
Three small manufacturers account for the remainder of the market. 
There may be other manufacturers/marketers not identified in sources 
FDA reviewed, but FDA believes there are a limited number and they 
would be small manufacturers. FDA concludes that this final rule would 
not have a significant economic impact on small entities, using the 
U.S. Small Business Administration designations for this industry (750 
employees). Together, fewer than 300 stockkeeping units (SKUs) are 
marketed. The manufacturer of the nationally branded product and some 
private label manufacturers of these products already include sodium 
content information in the labeling of their products. Any necessary 
relabeling (addition of sodium content labeling) will impose direct 
one-time costs on some manufacturers. FDA has been informed that the 
cost to relabel these products ranges from $500 to $3,500 per SKU. 
Using $3,500 per SKU, and assuming all SKUs would need to be relabeled, 
the total one-time cost to relabel these products would be $1,050,000. 
Actual costs will be lower because most of these products already 
include the sodium content information in their labeling.
    Manufacturers that have not voluntarily included sodium content 
information may also incur one-time costs to test their products to 
determine the sodium content. The cost to test for one cation (e.g., 
sodium) is about $150 for private label manufacturers. Assuming they 
repeat the testing, the total one-time costs for an estimated 10 
products would be $3,000.
    FDA considered but rejected several labeling alternatives: (1) A 
longer implementation period and (2) an exemption from coverage for 
small entities. A longer time period would unnecessarily delay the 
benefit of the new labeling to consumers who self-medicate with these 
products. FDA rejected an exemption for small entities because the 
labeling is also needed by consumers who purchase products marketed by 
those entities.
    For the reasons stated previously and under the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), FDA certifies that this final rule 
will not have a significant economic impact on a substantial number of 
small entities.

[[Page 69280]]

IV. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirement in this document is not 
subject to review by the Office of Management and Budget because it 
does not constitute a ``collection of information'' under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the labeling 
statements are 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)).

V. Environmental Impact

    FDA has determined under 21 CFR 25.31(a) 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. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
201 is amended as follows:

PART 201--LABELING

0
1. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

0
2. Section 201.64 is amended by adding paragraph (k) to read as 
follows:


Sec.  201.64   Sodium labeling.

* * * * *
    (k) The labeling of OTC drug products intended for rectal 
administration containing dibasic sodium phosphate and/or monobasic 
sodium phosphate shall contain the sodium content per delivered dose if 
the sodium content is 5 milligrams or more. The sodium content shall be 
expressed in milligrams or grams. If less than 1 gram, milligrams 
should be used. The sodium content shall be rounded-off to the nearest 
whole number if expressed in milligrams (or nearest tenth of a gram if 
expressed in grams). The sodium content per delivered dose shall follow 
the heading ``Other information'' as stated in Sec.  201.66(c)(7). Any 
product subject to this paragraph that contains dibasic sodium 
phosphate and/or monobasic sodium phosphate as an active ingredient 
intended for rectal administration and that is not labeled as required 
by this paragraph and that is initially introduced or initially 
delivered for introduction into interstate commerce after November 29, 
2005, is misbranded under sections 201(n) and 502(a) and (f) of the 
act.

    Dated: November 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26269 Filed 11-26-04; 8:45 am]
BILLING CODE 4160-01-S