[Federal Register: March 6, 2009 (Volume 74, Number 43)]
[Rules and Regulations]
[Page 9759-9765]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06mr09-2]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 310 and 347
[Docket No. FDA-1978N-0007] (Formerly Docket No. 78N-021A)
RIN 0910-AF42
Astringent Drug Products That Produce Aluminum Acetate; Skin
Protectant Drug Products for Over-the-Counter Human Use; Technical
Amendment
AGENCY: Food and Drug Administration, HHS.
[[Page 9760]]
ACTION: Final rule; technical amendment.
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SUMMARY: We (Food and Drug Administration (FDA)) are amending the final
monograph (FM) for over-the-counter (OTC) skin protectant astringent
drug products. This amendment clarifies that aluminum acetate
solutions, produced by dissolving aluminum sulfate tetradecahydrate and
calcium acetate monohydrate in powder or tablet form in water, are
generally recognized as safe and effective (GRASE) and not misbranded
as astringent drug products. The amendment also describes how
manufacturers should relabel these products to comply with the FM. We
are issuing this amendment in response to a citizen petition (CP) that
we received from a manufacturer of OTC astringent drug products. This
final rule is part of our ongoing review of OTC drug products.
DATES: Effective Date: This regulation is effective March 6, 2009.
Compliance Date: The compliance date for all products, regardless
of annual sales, is September 6, 2010.
FOR FURTHER INFORMATION CONTACT: Matthew R. Holman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993, 301-796-
2090.
SUPPLEMENTARY INFORMATION:
I. What Is the Regulatory History of This Rulemaking?
A. Advance Notice of Proposed Rulemaking (ANPR)
We published an ANPR for certain OTC skin protectant drug products
in the Federal Register on September 7, 1982 (47 FR 39436) (the 1982
ANPR). In the 1982 ANPR, the agency reported that the Advisory Review
Panel on OTC Miscellaneous External Drug Products (the Panel)
recommended that we classify solutions containing 2.5 to 5 percent
aluminum acetate as GRASE for topical use as an astringent. The 1982
ANPR includes the following terms when referring to this ingredient (47
FR 39436 at 39444 through 39446):
``aluminum acetate''
``aluminum acetate solution''
``Burow's solution''
Although some of the aluminum acetate products that the Panel
evaluated were powders and tablets that were dissolved in water (Refs.
1 and 2), those products, as manufactured, did not contain aluminum
acetate. Rather, those powders and tablets contained aluminum sulfate
and calcium acetate, which produced an aluminum acetate solution when
dissolved in water.
In addition, the Panel separately evaluated aluminum sulfate and
calcium acetate as OTC astringent single active ingredients (i.e., when
not in combination with each other). The Panel recommended that
aluminum sulfate, as a single active ingredient, is GRASE and not
misbranded only for use in a styptic pencil (47 FR 39436 at 39447 and
39448).\1\ The Panel recommended that calcium acetate be classified as
not GRASE or misbranded when used as a single active ingredient (47 FR
39436 at 39444). The Panel was not aware of any data demonstrating the
safety and effectiveness of calcium acetate, as a single active
ingredient, when used as an OTC astringent active ingredient in any
formulation.
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\1\ In the 1982 ANPR, we stated that the Panel had concluded
that aluminum sulfate is safe but that there were insufficient data
to establish its effectiveness for use as a styptic pencil (47 FR
39436 at 39447 and 39448). In the Federal Register of April 3, 1989
(54 FR 13490 at 13493), we stated that an apparent administrative
error had occurred in that the Panel had voted to classify aluminum
sulfate as GRASE and not misbranded for use in a styptic pencil.
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B. Proposed Rule
In the Federal Register of April 3, 1989 (54 FR 13490), we
published a proposed rule amending the tentative final monograph (TFM)
for OTC skin protectant drug products to include astringent drug
products (the 1989 TFM). In the 1989 TFM, we proposed monograph status
for aluminum acetate, as recommended by the Panel (54 FR 13490 at
13494). However, we revised the Panel's recommended concentration to
0.13 to 0.5 percent, indicating that the Panel did not take into
account further dilution of the 2.5 to 5 percent aluminum acetate
solution (54 FR 13490 at 13494 and 13496). We agreed with the Panel's
recommendation for calcium acetate and proposed that the ingredient be
classified as nonmonograph (54 FR 13490 at 13496). We also noted that
one comment mentioned that the USP (United States Pharmacopeia)
procedure for preparing Burow's Solution (aluminum acetate solution) de
novo does not pertain to modified aluminum acetate solutions prepared
from tablets or powders (54 FR 13490 at 13494).
C. Final Rule
In the Federal Register of October 21, 1993 (58 FR 54458), we
published a final rule in the form of a FM for OTC skin protectant drug
products that established conditions under which OTC astringent drug
products are GRASE and not misbranded (the 1993 skin protectant FM).
The 1993 skin protectant FM added GRASE astringent active ingredients
and labeling for astringents to 21 CFR part 347 subpart A. The 1993
skin protectant FM, which became effective on October 21, 1994,
includes 0.13 to 0.5 percent aluminum acetate as an active ingredient
in Sec. 347.12 (21 CFR 347.12) (then Sec. 347.10(a) (21 CFR
347.10(a))). The 1993 skin protectant FM specifies that, depending on
the formulation and concentration of the marketed product, the
manufacturer must provide adequate directions so that the resulting
solution to be used by consumers contains 0.13 to 0.5 percent aluminum
acetate.
In the 1993 skin protectant FM, we noted that calcium acetate was
listed in Sec. 310.545(a)(18)(ii) (21 CFR 310.545(a)(18)(ii)) as
nonmonograph in a final rule published on May 10, 1993 (58 FR 27636 at
27642).
D. Feedback Letter
A manufacturer submitted a letter in 1994 requesting clarification
whether its OTC astringent drug product, a powder containing aluminum
sulfate and calcium acetate, could continue to be marketed under the
1993 skin protectant FM (Ref. 3). The manufacturer stated that it
markets one of the products reviewed by the Panel in which aluminum
acetate was determined to be GRASE for OTC astringent drug products.
When dissolved in water according to labeled directions, the
manufacturer's product becomes an aluminum acetate solution with a
calcium sulfate precipitate.
In a 1995 letter to the manufacturer, we stated that the product
fails to comply with the 1993 skin protectant FM because it contains
the nonmonograph ingredient calcium acetate (Ref. 4). We suggested that
the manufacturer contact us to amend the 1993 skin protectant FM to
allow continued marketing of its product. Subsequently, the
manufacturer submitted a CP (Ref. 5).
II. Why Is FDA Issuing This Document?
We are issuing this technical amendment in response to the CP
submitted by an OTC astringent drug product manufacturer in 1995 (the
1995 CP) (Ref. 5). The 1995 CP was submitted by a manufacturer who
marketed one of the products reviewed by the Panel in which aluminum
acetate was determined to be GRASE for OTC astringent drug products
(see section I.D of this document). The 1995 CP requested that we
revise the skin protectant FM (Sec. 347.12(a) (then Sec. 347.10(a))
as follows, or in equivalent language having the same effect (Ref. 5):
``Aluminum acetate, 0.13 to 0.5 percent
[[Page 9761]]
(where the product as marketed consists of salts other than aluminum
acetate, or where the aluminum acetate concentration of the product as
marketed is other than 0.13 to 0.5 percent, the manufacturer must
provide adequate directions so that the resulting solution to be used
by the consumer consists of 0.13 to 0.5 percent aluminum acetate).''
The manufacturer intended ``salts other than aluminum acetate'' to
include dry formulations of aluminum sulfate plus calcium acetate. The
manufacturer argued that its labeled directions produce an aluminum
acetate solution that falls within the concentration range specified in
the 1993 skin protectant FM.
We have not taken any enforcement action against these powder and
tablet products that produce an aluminum acetate solution while
developing this document as our response to the 1995 CP. In this
document, we are granting the request in the 1995 CP to revise the 1993
skin protectant FM by including the combination of aluminum sulfate and
calcium acetate in powder and tablet dosage forms to prepare an
aluminum acetate solution.
III. What Changes to the Skin Protectant FM Is FDA Making in This
Document?
This document adds the GRASE combination of aluminum sulfate
tetradecahydrate and calcium acetate monohydrate in powder or tablet
form to produce a 0.13 to 0.5 percent aluminum acetate solution when
the powder or tablet is dissolved in the volume of water specified in
``Directions.'' This technical amendment also includes additional
labeling requirements for OTC astringent drug products that consist of
this GRASE combination of active ingredients.
Since we issued the 1993 skin protectant FM, the United States
Pharmacopeia/National Formulary (USP/NF) has added monographs for
Aluminum Sulfate and Calcium Acetate Tablets for Topical
Solution (Ref. 6) and
Aluminum Sulfate and Calcium Acetate for Topical Solution
(Ref. 7).
The second USP monograph is for products formulated as powders. The USP
monographs state that these products contain aluminum sulfate
tetradecahydrate and calcium acetate monohydrate, which are the hydrate
forms of aluminum sulfate and calcium acetate. When a tablet or powder
containing the aluminum sulfate tetradecahydrate and calcium acetate
monohydrate is dissolved in water, a chemical reaction occurs that
produces an aluminum acetate solution and a calcium sulfate
precipitate.
Rather than amend the aluminum acetate section of the 1993 skin
protectant FM as requested in the 1995 CP, we are redesignating
existing Sec. 347.20(b) as Sec. 347.20(c), and adding a new Sec.
347.20(b), to include the combination of aluminum sulfate
tetradecahydrate and calcium acetate monohydrate in powder and tablet
dosage forms to prepare an aluminum acetate solution. We are limiting
the combination of ingredients to powder and tablet dosage forms
because there are corresponding USP monographs for these dosage forms,
but not for other dosage forms (Refs. 6 and 7). New Sec. 347.20(b)
states:``Combination of ingredients to prepare an aluminum acetate
solution. Aluminum sulfate tetradecahydrate may be combined with
calcium acetate monohydrate in powder or tablet form to provide a 0.13
to 0.5 percent aluminum acetate solution when the powder or tablet is
dissolved in the volume of water specified in `Directions'.'' This
amendment provides an alternate approach to prepare the aluminum
acetate solution described in Sec. 347.12(a).
Marketed products have contained varying amounts of aluminum
sulfate and calcium acetate based on the amount of water in which the
powder or tablet is dissolved to make an aluminum acetate solution. For
example, a product with directions to use 16 ounces of water requires a
larger amount of each ingredient than a product with directions to use
12 ounces of water. Generally, the products have contained between 53
and 59 percent aluminum sulfate and 40 to 44 percent calcium acetate in
each tablet or powder. Inactive ingredients account for the other
amounts to make 100 percent.
Because of the varying amount of aluminum sulfate and calcium
acetate, we are not specifying an amount for each active ingredient
required in a product. However, this information is required to appear
in the product's labeling (see 21 U.S.C. 352(e)(1)(A)(ii) and Sec.
201.66(c)(2) (21 CFR 201.66(c)(2))). Labeling must state the amount of
each active ingredient in the product and those amounts, when dissolved
in the amount of water stated in the product's labeling, must produce a
0.13 to 0.5 percent aluminum acetate solution. We are providing
labeling in this document to allow manufacturers to continue to market
these products in this manner.
We are revising Sec. 347.52 (Labeling of astringent drug products)
(21 CFR 347.52), which describes specific labeling for products
containing aluminum sulfate tetradecahydrate and calcium acetate
monohydrate in powder or tablet dosage forms (see Sample OTC Astringent
Drug Product Label). ``Aluminum sulfate tetradecahydrate'' and
``calcium acetate monohydrate'' must appear under the ``Active
ingredients'' heading in Drug Facts, as is typical for OTC drug
products. Under the ``Purpose'' heading, an asterisk should follow the
word ``Astringent''. In addition, a statement explaining the asterisk
should be included in the ``Active ingredients/Purpose'' section:
``*When combined together in water, these ingredients form the active
ingredient aluminum acetate. See Directions.'' The ``Directions''
section should include instructions on preparing the aluminum acetate
solution (0.13 to 0.5 percent) from the powder(s) or tablet(s). These
directions will inform consumers that a solution is produced by
dissolving the powder(s) or tablet(s) in water. We believe this
labeling in the ``Active ingredients/Purpose'' and ``Directions''
sections adequately informs consumers that aqueous aluminum acetate is
acting as the astringent active ingredient.
The combination product containing aluminum sulfate
tetradecahydrate and calcium acetate monohydrate has the same
indications and warnings as other monograph astringent products
containing aluminum acetate. We are requiring that the ``for use as a
soak'' and ``for use as a compress or wet dressing'' subheadings in the
``Directions'' section appear in bold type to make it easier for
consumers to read and follow the different parts of the directions for
these products (see Sample OTC Astringent Drug Product Label). For
consistency in labeling, we are also requiring that the same two
subheadings in the ``Directions'' section of OTC aluminum acetate
solution drug products described in Sec. 347.12(a) appear in bold
type. The information under these subheadings for both types of
aluminum acetate drug products (i.e., dry and solution formulations) is
still required to appear in a bulleted format (see Sec.
347.52(d)(1)(i) and (d)(1)(ii)).
The following sample OTC astringent drug product label illustrates
the labeling for products containing aluminum sulfate tetradecahydrate
and calcium acetate monohydrate in powder or tablet dosage forms to
produce an aluminum acetate solution:
BILLING CODE 4160-01-S
[[Page 9762]]
[GRAPHIC] [TIFF OMITTED] TR06MR09.000
BILLING CODE 4160-01-C
[[Page 9763]]
This sample label includes the specific labeling required for these
products in this technical amendment as well as the general labeling
required by the 1993 skin protectant FM. The format and sequence of the
information and the font sizes for the title, heading, subheadings,
text, and other graphic features must be in accordance with Sec.
201.66.
In addition to adding new Sec. 347.20(b), we are revising Sec.
310.545(a)(18)(ii), which currently lists calcium acetate as a
nonmonograph active ingredient that cannot be included in OTC
astringent drug products. That section now reads as follows: ``Calcium
acetate (except calcium acetate monohydrate when combined with aluminum
sulfate tetradecahydrate to provide an aluminum acetate solution as
described in Sec. 347.20(b)).'' Therefore, calcium acetate is still
nonmonograph except in products marketed under new Sec. 347.20(b).
Because this document adds new Sec. 347.20(b), we are
redesignating existing Sec. 347.20(b), (c), and (d) as Sec.
347.20(c), (d), and (e), respectively. We are also revising the
warnings in 21 CFR 347.50(c) to reflect the Drug Facts format in Sec.
201.66, while not changing the meaning of these warnings. The Sample
OTC Astringent Drug Product Label reflects all of these revisions.
IV. Analysis of Impacts
We have examined the impacts of this final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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). We conclude that this
final rule is not a significant regulatory action 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. Because only a limited number of products will need
to be relabeled, we certify that this final rule will not have a
significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $130 million, using the most current (2007) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
The purpose of this final rule is to amend the 1993 skin protectant
FM to add the combination of aluminum sulfate tetradecahydrate and
calcium acetate monohydrate for products that include appropriate
amounts of these ingredients and adequate directions to produce an
aluminum acetate solution within the monograph concentration range.
This amendment describes a methodology for manufacturers of these OTC
astringent drug products to relabel their products and market them in
compliance with the 1993 skin protectant FM.
We have identified two OTC skin protectant astringent drug
products, each with several stockkeeping units (SKUs) (individual
products, packages, and sizes), that may need to be relabeled. While we
are aware of several other products that are no longer marketed, there
may be a few marketed products of which we are not currently aware.
Accordingly, we estimate that there may be 5 products with 5 to 10 SKUs
that may be affected by this final rule.
We have updated the weighted average cost to relabel that we
estimated for the final rule requiring uniform label formats of OTC
drug products (64 FR 13254 at 13279 to 13281, March 17, 1999) (i.e.,
$3,600 x 1.164\2\ = $4,190 per SKU). Assuming up to 10 affected OTC
SKUs in the marketplace, total one-time costs of relabeling could be
$41,900 (i.e., 10 x $4,190). Because frequent labeling redesigns are a
recognized cost of doing business in the OTC drug industry, these costs
may be less. Manufacturers that make voluntary market-driven changes to
their labeling during the implementation period can implement the
regulatory requirements for a nominal cost. All products, including
those with annual sales less than $25,000, will have 18 months
following publication of the final rule to comply with the 1993 skin
protectant FM. Therefore, many of the labeling revisions may be done in
the normal course of business. These steps should help to minimize the
impact on small entities by providing enough time for implementation to
enable entities to use up existing labeling stock. In addition, the
final rule does not require any new reporting or recordkeeping
activities.
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\2\ The annual PPI for pulp, paper, and allied products (the
major cost driver for labeling) rose from 174.1 to 202.6 between
1998 and 2005 (see http://data.bls.gov/cgi-bin/surveymost). We have
verified the Web site address, but we are not responsible for
subsequent changes to the Web site after this document publishes in
the Federal Register.
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This final rule also requires manufacturers of the aluminum acetate
solution products described in Sec. 347.12(a) to make two very minor
changes in the labeling of their products. They will need to change the
two ``for use'' subheadings in the directions from standard to bold
type and should be able to do so at a negligible cost. We estimate that
less than 10 SKUs will be affected by this minor change. This final
rule will not impose a significant economic burden on affected
entities. Therefore, we certify that this final rule will not have a
significant economic impact on a substantial number of small entities.
No further analysis is required under the Regulatory Flexibility Act (5
U.S.C. 605(b)).
V. Paperwork Reduction Act of 1995
We conclude 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
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)).
VI. Environmental Impact
We have 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.
VII. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
will have a preemptive effect on State law. Section 4(a) of the
Executive order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress
[[Page 9764]]
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Section 751 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 379r) is an express preemption provision.
Section 751(a) of the act (21 U.S.C. 379r(a)) provides that:
``* * * no State or political subdivision of a State may establish or
continue in effect any requirement--* * * (1) that relates to the
regulation of a drug that is not subject to the requirements of section
503(b)(1) or 503(f)(1)(A); and (2) that is different from or in
addition to, or that is otherwise not identical with, a requirement
under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C.
1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451
et seq.).''
Currently, this provision operates to preempt States from imposing
requirements related to the regulation of nonprescription drug
products. (See section 751(b) through (e) of the act for the scope of
the express preemption provision, the exemption procedures, and the
exceptions to the provision.) This final rule clarifies that OTC
astringent drug products containing aluminum sulfate tetradecahydrate
and calcium acetate monohydrate in powder or tablet form for dissolving
in water to produce an aluminum acetate solution are GRASE and not
misbranded. The final rule also describes how manufacturers should
relabel these products to comply with the 1993 skin protectant FM.
Although this final rule would have a preemptive effect, in that it
would preclude States from issuing requirements related to these OTC
astringent drug products that are different from or in addition to, or
not otherwise identical with a requirement in the final rule, this
preemptive effect is consistent with what Congress set forth in section
751 of the act. Section 751(a) of the act displaces both State
legislative requirements and State common law duties. We also note that
even where the express preemption provision is not applicable, implied
preemption may arise. See Geier v. American Honda Co., 529 U.S. 861
(2000).
We believe that the preemptive effect of the final rule would be
consistent with Executive Order 13132. Section 4(e) of the Executive
order provides that ``when an agency proposes to act through
adjudication or rulemaking to preempt State law, the agency shall
provide all affected State and local officials notice and an
opportunity for appropriate participation in the proceedings.'' We
provided the States with an opportunity for appropriate participation
in this rulemaking when we sought input from all stakeholders through
publication of the 1993 skin protectant FM. We received no comments
from any States on the final rulemaking.
In addition, on December 17, 2008, FDA's Division of Federal and
State Relations provided notice via fax and e-mail transmission to
elected officials of State governments and their representatives of
national organizations. The notice provided the States with further
opportunity for input on the rule. It advised the States of the
publication of the final rule and encouraged State and local
governments to review the notice and to provide any comments to the
docket (Docket No. 1978N-0021A), by a date 30 days from the date of the
notice (i.e., by January 16, 2009), or to contact certain named
individuals. We did not receive any comments in response to this
notice. The notice has been filed in the above-numbered docket.
In conclusion, we believe that we have complied with all of the
applicable requirements under the Executive order and have determined
that the preemptive effects of this rule are consistent with Executive
Order 13132.
VIII. References
The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852, under Docket No. FDA-1978N-0007
(formerly Docket No. 1978N-021A) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Bluboro product label, Appendix A to CP1.
2. Domeboro product label.
3. Letter from S. Buxbaum, Allergan, to R. Heller, FDA, dated
January 24, 1994, Appendix C to CP1.
4. Letter from B. Williams, FDA, to T. Mead, Allergan, dated
January 2, 1995, Appendix D to CP1.
5. CP1.
6. The United States Pharmacopeia 31-National Formulary 26, The
United States Pharmacopeial Convention, Inc., Rockville, MD, pp.
1360, 2008.
7. The United States Pharmacopeia 31-National Formulary 26, The
United States Pharmacopeial Convention, Inc., Rockville, MD, p.
1359, 2008.
List of Subjects
21 CFR Part 310
Administrative practice and procedures, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.
21 CFR Part 347
Labeling, Over-the-counter drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
310 and 347 are amended as follows:
PART 310--NEW DRUGS
0
1. The authority citation for 21 CFR part 310 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b-263n.
0
2. Section 310.545 is amended by revising the entry for calcium acetate
in paragraph (a)(18)(ii), by revising paragraph (d) introductory text
and paragraph (d)(11), and by adding new paragraph (d)(39) to read as
follows:
Sec. 310.545 Drug products containing certain active ingredients
offered over-the-counter (OTC) for certain uses.
(a) * * *
(18) * * *
(ii) * * *
* * * * *
Calcium acetate (except calcium acetate monohydrate when combined with
aluminum sulfate tetradecahydrate to provide an aluminum acetate
solution as described in Sec. 347.20(b)) of this chapter
* * * * *
(d) Any OTC drug product that is not in compliance with this
section is subject to regulatory action if initially introduced or
initially delivered for introduction into interstate commerce after the
dates specified in paragraphs (d)(1) through (d)(39) of this section.
* * * * *
(11) November 10, 1993, for products subject to paragraphs
(a)(8)(ii), (a)(10)(v) through (a)(10)(vii), (a)(18)(ii) (except
products that contain ferric subsulfate as covered by paragraph (d)(22)
of this section and except products that contain calcium acetate
monohydrate as covered by paragraph (d)(39) of this section) through
(a)(18)(v)(A), (a)(18)(vi)(A), (a)(22)(ii), (a)(23)(i), (a)(24)(i), and
(a)(25) of this section.
* * * * *
(39) September 6, 2010, for products subject to paragraph
(a)(18)(ii) of this section that contain calcium acetate monohydrate,
except as provided in Sec. 347.20(b) of this chapter.
PART 347--SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE
0
3. The authority citation for 21 CFR part 347 continues to read as
follows:
[[Page 9765]]
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
0
4. Section 347.20 is amended by redesignating paragraphs (b), (c), and
(d) as paragraphs (c), (d), and (e), respectively, and by adding new
paragraph (b) to read as follows:
Sec. 347.20 Permitted combinations of active ingredients.
* * * * *
(b) Combination of ingredients to prepare an aluminum acetate
solution. Aluminum sulfate tetradecahydrate may be combined with
calcium acetate monohydrate in powder or tablet form to provide a 0.13
to 0.5 percent aluminum acetate solution when the powder or tablet is
dissolved in the volume of water specified in ``Directions.''
* * * * *
0
5. Section 347.52 is amended by revising paragraph (a) and (b)(1)
paragraph heading, and by revising paragraphs (c) and (d)(1), and by
adding new paragraph (d)(4) to read as follows:
Sec. 347.52 Labeling of astringent drug products.
(a) Statement of identity. The labeling of the product contains the
established name of the drug, if any, and identifies the product as an
``astringent.'' For products containing the combination of aluminum
sulfate tetradecahydrate and calcium acetate monohydrate identified in
Sec. 347.20(b), under the ``Purpose'' heading identified in Sec.
201.66(c)(3) of this chapter, the labeling of each active ingredient in
the product states ``Astringent*'', which is followed by the statements
``* When combined together in water, these ingredients form the active
ingredient aluminum acetate. See [the following in bold italic type]
Directions.''
(b) Indications. * * *
(1) For products containing aluminum acetate identified in Sec.
347.12(a) or the combination of aluminum sulfate tetradecahydrate and
calcium acetate monohydrate identified in Sec. 347.20(b). * * *
* * * * *
(c) Warnings. The labeling of the product contains the following
warnings under the heading ``Warnings'':
(1) For all products--(i) The labeling states ``For external use
only''.
(ii) The labeling states ``When using this product [bullet] avoid
contact with eyes. If contact occurs, rinse thoroughly with water.''
(2) For products containing aluminum acetate identified in Sec.
347.12(a), witch hazel identified in Sec. 347.12(c), or the
combination of aluminum sulfate tetradecahydrate and calcium acetate
monohydrate identified in Sec. 347.20(b). The labeling states ``Stop
use and ask a doctor if [bullet] condition worsens or symptoms last
more than 7 days''.
(3) For products containing aluminum acetate identified in Sec.
347.12(a) or the combination of aluminum sulfate tetradecahydrate and
calcium acetate monohydrate identified in Sec. 347.20(b) when labeled
for use as a compress or wet dressing. The labeling states ``When using
this product [bullet] do not cover compress or wet dressing with
plastic to prevent evaporation''.
(4) For products containing aluminum acetate identified in Sec.
347.12(a) or the combination of aluminum sulfate tetradecahydrate and
calcium acetate monohydrate identified in Sec. 347.20(b) when labeled
for use as a soak, compress, or wet dressing. The labeling states
``When using this product [bullet] in some skin conditions, soaking too
long may overdry''.
(d) Directions. * * *
(1) For products containing aluminum acetate identified in Sec.
347.12(a) or the combination of aluminum sulfate tetradecahydrate and
calcium acetate monohydrate identified in Sec. 347.20(b)--(i) For
products used as a soak. ``For use as a soak: [preceding words in bold
type] [bullet] soak affected area for 15 to 30 minutes as needed, or as
directed by a doctor [bullet] repeat 3 times a day or as directed by a
doctor [bullet] discard solution after each use'' .
(ii) For products used as a compress or wet dressing. ``For use as
a compress or wet dressing: [preceding words in bold type] [bullet]
soak a clean, soft cloth in the solution [bullet] apply cloth loosely
to affected area for 15 to 30 minutes [bullet] repeat as needed or as
directed by a doctor [bullet] discard solution after each use''.
* * * * *
(4) For products containing the combination of aluminum sulfate
tetradecahydrate and calcium acetate monohydrate identified in Sec.
347.20(b)--(i) For powder dosage form. The labeling states ``[bullet]
dissolve 1 to 3 packets in [insert volume] of cool or warm water
[bullet] stir until fully dissolved; do not strain or filter. The
resulting mixture contains [insert percent] (1 packet), [insert
percent] (2 packets), or [insert percent] (3 packets) aluminum acetate
and is ready for use.'' These statements shall be the first statements
under the heading ``Directions''.
(ii) For tablet dosage form. The labeling states ``[bullet]
dissolve 1 to 3 tablets in [insert volume] of cool or warm water
[bullet] stir until fully dissolved; do not strain or filter. The
resulting mixture contains [insert percent] (1 tablet), [insert
percent] (2 tablets), or [insert percent] (3 tablets) aluminum acetate
and is ready for use.'' These statements shall be the first statements
under the heading ``Directions''.
* * * * *
Dated: February 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4746 Filed 3-5-09; 8:45 am]
BILLING CODE 4160-01-S