[Federal Register Volume 71, Number 238 (Tuesday, December 12, 2006)]
[Proposed Rules]
[Pages 74474-74482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 1998N-0337C]

RIN 0910-AD47


Over-the-Counter Human Drugs; Labeling Requirements; Proposed 
Rule

AGENCY: Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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SUMMARY:  The Food and Drug Administration (FDA) is proposing to amend 
its final rule that established standardized format and content 
requirements for the labeling of over-the-counter (OTC) drug products 
(Drug Facts Rule, codified at 21 CFR 201.66). This amendment proposes a 
definition and the option of alternative labeling requirements for 
``convenience-size'' OTC drug packages.

DATES:  Submit written comments by April 11, 2007; written comments on 
FDA's economic impact determination by April 11, 2007. See section X of 
this document for the proposed effective date of a final rule based on 
this document.

ADDRESSES: You may submit comments, identified by Docket No. 1998N-
0337C and/RIN number 0910-AD47, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No. and Regulatory Information Number (RIN) (if a RIN number 
has been assigned) for this rulemaking. All comments received may be 
posted without change to http://www.fda.gov/ohrms/dockets/default.htm, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow or Cazemiro R. 
Martin, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5426, Silver 
Spring, MD 20993-0002, 301-796-2090.

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 
(Drug Facts Rule). Those requirements are codified in 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, products 
marketed under 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 products for 
which there is no final OTC drug monograph or approved NDA/ANDA.
    In the Drug Facts Rule and in subsequent notices, FDA provided 
dates by which OTC drug products had to be in compliance with the new 
labeling requirements. FDA provided a chart in the Drug Facts Rule (64 
FR 13254 at 13274) that summarized the time periods within which the 
various categories of marketed OTC drug products were required to 
comply with the final rule. Unless otherwise stated,

[[Page 74475]]

all time periods in the chart began on the effective date of the final 
rule. The chart was subsequently updated on June 20, 2000 (65 FR 38191 
at 38193) and April 5, 2002 (67 FR 16304 at 16306 to 16307).
    In the June 20, 2000, update, FDA clarified the applicable 
compliance dates in situations where relabeling was required by both 
the Drug Facts Rule and another rule. In the April 5, 2002, update, FDA 
delayed the compliance dates for ``convenience-size'' OTC drug 
products. Those products are the subject of this proposed rule.

A. Delay of Compliance Dates for ``Convenience-Size'' OTC Drug Products

    FDA's delay notice of April 5, 2002, postponed the Drug Facts Rule 
compliance dates for all ``convenience-size'' OTC drug product packages 
that do the following: (1) Contain no more than two doses of an OTC 
drug, and (2) because of their limited available labeling space, would 
require more than 60 percent of the total surface area available to 
bear labeling to meet the requirements set forth in Sec.  201.66(d)(1) 
through (d)(9) and would therefore qualify for the labeling 
modifications currently set forth in Sec.  201.66(d)(10). ``Dose'' was 
defined in the delay notice as the maximum single-serving for an adult 
(or a child for products marketed only for children) as specified in 
the product's directions for use. (See 67 FR 16304 at 16306.)
    FDA's delay does not include single- or double-dose OTC drug 
packages that do not qualify for the labeling conditions in Sec.  
201.66(d)(10) because they can accommodate the Drug Facts labeling 
required in Sec.  201.66(d)(1) through (d)(9) using 60 percent or less 
of their total surface area available to bear labeling. Examples of 
such products include some enemas, disposable douche products, and 
ipecac syrup products intended for emergency treatment use in 
poisonings. (See 67 FR 16304 at 16306 to 16307.)

B. Citizen Petition Requests Definition

    FDA published the notice of delay for ``convenience-size'' OTC drug 
product packages in response to a citizen petition (Ref. 1) submitted 
by Lil' Drug Store Products, Inc. (Lil'). Lil' asked FDA to define 
``convenience-size'' OTC drug products and to modify the labeling and 
content requirements of the Drug Facts Rule with respect to such 
products. Lil' proposed that ``convenience-size'' OTC drug products be 
defined as packages sold to the public that contain one or two doses of 
an OTC drug product. Lil' also proposed that ``dose'' be defined as a 
manufacturer's recommended serving. In addition, Lil' requested that 
FDA modify the requirements of Sec.  201.66 for these ``convenience-
size'' OTC drug products by permitting a reduced version of the OTC 
Drug Facts labeling to appear on the external packaging of such 
products, while requiring fully compliant Drug Facts labeling to appear 
on the inside of the package through the use of package inserts or 
inner-package printing. Lil' stated that, under its proposal, the 
labeling on the external packaging would continue to include medically 
relevant information, would be consistent with the retail environment 
in which ``convenience-size'' OTC drug products are sold, and would 
still adequately enable consumers to make the unique purchasing 
decision associated with OTC drug use. Lil' described the 
``convenience-size'' products that it sells as recognized, brand-name, 
quality OTC drug products packaged in small doses and made available to 
the consumer at his or her point of need.
    Lil' stated that there were medical and policy rationales for its 
request centering on the dosing limitations of ``convenience-size'' 
packages. Because such packages contain only one or two doses of an OTC 
drug product, Lil' reasoned that it is acceptable and appropriate for 
certain information required under the Drug Facts Rule to appear inside 
the packages, either in a package insert or by inner-package printing. 
Lil' proposed that the outer product labeling of a convenience-size 
package still contain the complete ``Drug Facts'' title, active 
ingredients, purpose, uses, and inactive ingredients, but that it be 
allowed to abbreviate certain warnings and omit other required 
information. Lil' also proposed adding the following statement in bold, 
italic, seven-point Helvetica font: ``Please read complete Drug Facts 
information inside prior to use.'' Lil' then proposed that the 
remaining information required by the Drug Facts Rule, including 
directions for use, certain warnings, and questions or comments, be 
allowed to appear inside the package, and it provided supporting 
reasons. (See section III.C of this document for a summary of Lil's 
suggestions and reasoning.)
    In its response (Ref. 2) to the Lil' citizen petition, FDA stated 
that it had carefully reviewed the data and information in the petition 
and agreed that some accommodation for ``convenience-size'' packages 
might be appropriate. FDA stated that it intended to prepare, for 
publication in a future issue of the Federal Register, a proposed rule 
that would, if finalized, amend the Drug Facts Rule by defining 
``convenience-size'' OTC drug packages and addressing Drug Facts 
labeling requirements for such products. The proposed rule would also 
provide all interested parties an opportunity to comment on the 
viability, desirability, and impact of the proposed rule, and to 
respond to specific questions posed by FDA.

II. The Basis for Optional Alternative Labeling for Convenience-Size 
OTC Drug Packages

    FDA believes, from a public health perspective, that convenience-
size OTC drug packages may not need to have all of the labeling 
information required by the Drug Facts Rule on the outer package. This 
belief is based on the reduced risks posed by the limited amount of the 
active ingredient(s) contained in convenience-size packages, 
particularly because most of these packages do not provide for 
repetitive dosing. If a package contains only one or two doses of an 
OTC drug product, FDA believes there is a significantly reduced 
likelihood of an overdose occurring from consumption of the entire 
contents of the package. Further, FDA believes there is a corresponding 
reduction in the likelihood of other adverse side effects.
    FDA also believes, as Lil' asserted in its petition, that many 
consumers who purchase and use convenience-size packages of an OTC drug 
product do so because they have an immediate need, often in a location 
away from home, to take a dose or two of the product. These consumers 
often purchase convenience size drug packages for immediate consumption 
or other very short-term use and may not be as concerned at the time of 
purchase about labeled statements regarding when to stop use of the 
product and ask a doctor for assistance, overdose warnings, directions 
for continued dosing, or storage information.
    Lil' was also concerned that increasing the standardized size of 
``convenience packages'' to comply with the Drug Facts Rule would 
inhibit the sale of such packages from convenience stores and vending 
machines, where space is limited and larger packages can not be 
accommodated.
    Thus, given the unique circumstances associated with the purchase 
and use of ``convenience-size'' OTC drug products, FDA believes that 
some modification of the current labeling requirements set forth under 
Sec.  201.66(d)(10) can be achieved without jeopardizing the public 
health or undermining the important goals of the act or the Drug Facts 
Rule. FDA considers such a

[[Page 74476]]

modification to be especially important if failure to address this 
issue means that ``convenience-size'' OTC drug products will no longer 
be as available or accessible to consumers.
    FDA has determined, however, that certain critical warnings (e.g., 
allergic reactions, do not use situations, drug/drug interactions, 
risks associated with subsequent operation of a motor vehicle or 
machinery) and other information (e.g., inactive ingredients) must 
appear on the outer carton of convenience-size packages to allow 
consumers to accurately assess certain potential risks associated with 
the selection and use of the drug product at the time of purchase.
    Further, FDA believes that complete product information should be 
provided to consumers with ``convenience-size'' packages, regardless of 
whether it is available at the point of purchase. For example, 
information about repeat dosing need not appear on the outside carton 
or wrapper of a ``convenience-size'' package, but it should appear on 
the inside package labeling in an insert or in inner-package printing 
for consumers who may purchase more than one package at a time.
    Moreover, FDA strongly believes that the labeling modifications it 
is proposing for convenience-size packages should be narrowly applied 
and are not appropriate for packages of the same product that contain 
more than two doses. FDA believes that consumers who buy packages 
containing more than two doses customarily intend to take the product 
over a longer period of time than consumers who buy convenience-size 
packages. FDA believes that consumers who purchase packages with more 
than two doses should have complete information available at the time 
of purchase, so they can make fully informed decisions about prolonged 
use of the product.
    For the reasons stated previously, FDA is proposing to modify the 
Drug Facts labeling requirements in Sec.  201.66 for convenience-size 
OTC drug products as set forth in sections III.A, III.B, and III.C of 
this document. FDA believes its proposal will help achieve an 
appropriate balance between the consumer safety interests of the act 
and the Drug Facts Rule and the desire to ensure continued access to 
convenience-size OTC drug products in the marketplace.

III. FDA's Proposal

A. Definition of a Convenience-Size Package

    FDA believes that the definition of a ``convenience-size'' OTC drug 
package should be a function of both the number of doses contained in 
the package and the size of the package. FDA's proposed definition of 
convenience-size is set forth in proposed paragraph 201.66(d)(5). This 
definition addresses the number of doses and the package size.
1. Number of Doses
    FDA considers a limited number of doses as one of the key criteria 
in any meaningful definition of ``convenience-size.'' FDA proposes that 
the definition of ``convenience-size'' be limited to OTC drug packages 
that contain no more than two doses of an OTC drug product. In the 
notice of April 5, 2002, partial delay of compliance dates, FDA defined 
a ``dose'' as the maximum single-serving for an adult (or a child for 
products marketed only for children), as specified in the product's 
directions for use (67 FR 16304 at 16306). FDA is including the same 
definition in this proposal.
    FDA has found that some currently marketed OTC convenience-size 
drug products have directions for both adults and children. In most 
cases, the child's dose is one-half the adult dose. For example, in 
many products where the adult dose is two dosage units, the child's 
dose is one dosage unit. FDA did not address this type of package in 
the April 5, 2002, partial delay of compliance dates. For safety 
reasons, FDA is proposing that, for products marketed with directions 
for use for both adults and children, a ``dose'' be defined as the 
maximum single serving based on the child's dose.
    Those OTC drug monographs that provide directions for both children 
and adults generally give manufacturers the flexibility to market the 
OTC drug package to adults only, or to children only, or to both adults 
and children, so long as the package labeling bears the warnings that 
correspond to the age group(s) for whom the product is intended (see, 
e.g., 21 CFR 341.74(c) and 341.80(c)). Therefore, FDA does not believe 
that its proposed definition of ``dose'' will unduly hamper a 
manufacturer's ability to market convenience size packages to adults, 
but instead will provide a necessary safeguard against potential 
overdose in children in those instances where such products are 
marketed for children's use.
    This proposed definition of ``dose'' would also apply to sample and 
trial-size packages that contain only one or two dosage units of an OTC 
drug. It would not apply to trial-size packages, or to any other small 
package sizes, that contain more than two doses and are sold in a 
retail setting.
2. Package Size
    With respect to package size, FDA proposes that the definition of 
convenience-size be limited to those packages that qualify for the 
current labeling modification in Sec.  201.66(d)(10) but which, because 
of their limited available labeling space, would require more than 60 
percent of the total surface area available to bear labeling to meet 
the requirements set forth in Sec.  201.66(d)(10). Thus, under the 
proposed rule, one or two dose OTC drug packages that qualify for, and 
can accommodate, the current labeling modifications provided in Sec.  
201.66(d)(10) with 60 percent or less of their available labeling space 
would not meet the definition of ``convenience-size'' package in 
proposed Sec.  201.66(b)(5). Only those ``convenience-size'' OTC drug 
packages that are so small that they cannot accommodate the modified 
drug facts labeling in Sec.  201.66(d)(10) with 60 percent or less of 
their available labeling space would be allowed to bear the optional 
alternative labeling set forth in new Sec.  201.66(d)(11). We note that 
there are many single-dose OTC products that are packaged in containers 
that are too large to qualify for the modifications in Sec.  
201.66(d)(10) (e.g., most enemas and disposable medicated douche 
products).
    FDA invites specific comment on the following issues:
    1. Whether the definition of ``dose'' should be different from that 
proposed and, if so, why. For those suggesting that the definition of 
dose be either expanded or narrowed, please explain the precise 
rationale for such a suggestion and explain how your proposed 
definition could be implemented to be meaningfully limited;
    2. Whether the criteria regarding package size in proposed Sec.  
201.66(b)(5) should be different and, if so, why. For those suggesting 
that the size criteria be either expanded or narrowed, please explain 
the precise rationale for such a suggestion;
    3. Whether there are any data or evidence to support Lil's 
assertion that increasing package size to accommodate all of the 
information currently required under Sec.  201.66(d)(10) will force 
traditional OTC convenience-size drug products out of the retail 
marketplace and/or reduce consumer access to such packages;
    4. The relative public health risks associated with use of OTC 
convenience-size drug packages and the types of labeling information 
that must (or need not) be available at the point of

[[Page 74477]]

purchase to ensure the safe and effective use of such products;
    5. How the proposed definition of ``dose'' (or any other suggested 
definition of ``dose'') might apply to topical products and how it 
might be possible to include OTC ``convenience-size'' topical drug 
products within this proposed labeling modification;
    6. Whether there are any data to support Lil's assertion that most 
OTC convenience-size drug products are purchased for an immediate need 
to take a dose or two of the drug (as opposed to repeat dosing); and
    7. Whether there are reasons to oppose any labeling modification 
for OTC convenience-size drug products. For those opposing any 
modification to the Drug Facts Rule for OTC convenience-size packages, 
please explain the precise rationale for your position and provide 
evidence, if any, to support your concerns.

B. Exceptions to the Proposed Definition

    For public health reasons, FDA proposes to exempt from the 
definition of ``convenience-size'' several OTC drug products used for 
poison treatment that are marketed in single-dose containers. These 
include syrup of ipecac and activated charcoal. Syrup of ipecac is 
limited by regulation (21 CFR 201.308(c)) to 1 fluid ounce (30 
milliliter (mL)) packages for OTC sale. The usual dosage is one 
tablespoon (15 mL) in persons over 1 year of age (Sec.  201.308(c)(3)). 
FDA has proposed that the dosage be revised to 2 tablespoonsful (30 mL) 
for adults and children 12 years of age and over and to 1 tablespoonful 
(15 mL) for children 1 to under 12 years of age. (See proposed Sec.  
357.54(d), 50 FR 2244 at 2261, January 15, 1985). Activated charcoal is 
usually marketed in packages containing a minimum of one dose of 20 
grams. (See proposed section 357.52(d)(1), 50 FR 2244 at 2261).
    FDA considers it important that all of the labeling information for 
these products be available to consumers at the time of purchase. FDA 
also believes that, unlike most convenience-size OTC drug products, 
poison treatments are not purchased for immediate use, but are often 
acquired for subsequent access within the home in case of an emergency. 
FDA is therefore concerned that if some of the important information 
for using these products only appeared on a package insert and that 
insert got separated from the package before the product was used, the 
consumer would not have the necessary information at the time the 
product was needed, possibly resulting in serious health consequences. 
Those single dose OTC syrup of ipecac and activated charcoal packages 
that qualify for the labeling modification in Sec.  201.66(d)(10) may 
still be labeled according to the modifications set forth in that 
section. However, for the reasons stated above, FDA proposes to exclude 
them from the definition of ``convenience-size'' in Sec.  201.66(b)(5) 
and the additional labeling modifications proposed in Sec.  
201.66(d)(11), regardless of package size.
    Because there currently is no final monograph for OTC poison 
treatment drug products, FDA does not know how many manufacturers, 
repackers, and distributors of these products have attempted to develop 
Drug Facts labeling for these products. FDA invites comment, especially 
from companies that prepare labeling for these products, about how the 
labeling proposed in Sec.  357.52 and 357.54 (50 FR 2244 at 2261) would 
best fit on the immediate and outside containers when converted to the 
new Drug Facts format. Interested parties are invited to submit draft 
labeling in response to this proposed rule for FDA to evaluate. FDA 
also invites specific comment on whether there are other OTC drug 
products that should not be eligible for the proposed ``convenience-
size'' labeling format, even if such products otherwise meet the 
definition set forth in proposed Sec.  201.66(b)(5).

C. Optional Alternative Labeling for Convenience-Size Packages: 
Discussion

    FDA agrees with Lil' that certain Drug Facts information must fully 
appear on the outer product labeling of a convenience-size OTC drug 
package, regardless of the size of that package. This information 
includes the ``Drug Facts'' title, active and inactive ingredients, 
purpose(s), use(s), certain warnings, and some of the other information 
required by Sec.  201.66(c)(7). FDA considers this information an 
essential part of Sec.  201.66 that must be available to all consumers 
at the point of purchase. FDA also considers the warnings in Sec.  
201.66(c)(5)(i), (c)(5)(ii), and (c)(5)(iii) essential information that 
should appear in full on the outside of all OTC convenience-size 
packages because these sections contain especially important warning 
information that might influence a consumer's purchase decision at the 
point of sale. Regarding the other applicable warnings and directions, 
FDA has the following comments:

    1. Section 201.66(c)(5)(iv): This section requires the warning 
subheading ``Ask a doctor before use if you have'' and includes 
warnings for certain pre-existing conditions and warnings for persons 
experiencing certain symptoms. Lil' pointed out that the warnings under 
this heading are those intended only for situations in which consumers 
should not use the product until a doctor is consulted. Lil' contended 
that the information, while important, becomes less so given the low 
dosage being consumed and the unlikely negative side effects of such a 
low dosage, and this information can be safely included inside the 
outer carton of a convenience-size package.
    FDA disagrees. Information under this subheading would include 
disease conditions such as diabetes, glaucoma, high blood pressure, 
heart disease, thyroid disease, and trouble urinating due to an 
enlarged prostate gland. Consumers who have these conditions need to be 
informed at the point of purchase that the product may have an 
undesired effect because of the pre-existing condition(s). This 
potential problem for an adverse side effect exists whether the 
consumer is taking a single dose from a convenience-size or multiple 
doses over time from a larger package.
    2. Section 201.66(c)(5)(v): This section requires the warning 
subheading ``Ask a doctor or pharmacist before use if you are'' and is 
followed by all drug-drug and drug-food interaction warnings. Lil' 
suggested this information need not appear on the outside of the carton 
because there are generally no pharmacies located in the retail 
environment in which most OTC convenience-size packages are sold.
    FDA disagrees. FDA believes that this information must appear on 
the outside of the carton to ensure it is accessible to consumers at 
the point of purchase. For certain OTC drug products, the warnings 
under this heading inform consumers not to take the product if they are 
taking sedatives or tranquilizers. FDA believes that most consumers 
will know if they are taking a sedative or tranquilizer and, thus, can 
make the informed decision to avoid a product that has this warning, 
even when the purchase occurs in a non-pharmacy outlet.
    3. Section 201.66(c)(5)(vi): This section requires the warning 
subheading ``When using this product'' and provides information on the 
side effects that may occur and substances or machinery to avoid when 
using the product. FDA believes, as Lil' suggested, that all 
information about potential drowsiness, avoiding alcohol, and using 
care when driving a motor vehicle or operating machinery must appear in 
the external package labeling.

[[Page 74478]]

    However, FDA acknowledges there may be other information that 
appears under this subheading that could appear on the inside package 
labeling of convenience-size packages without jeopardizing public 
health or undermining the basic purpose of Sec.  201.66. Examples 
include information about not using the product at certain times or 
certain side effects that may occur (e.g., stomach discomfort, cramps). 
FDA invites specific comments and suggestions, with supportive reasons, 
about other information under this subheading that could appear on the 
inside package labeling or should remain on the outside of the package.
    4. Section 201.66(c)(5)(vii): This section requires the warning 
subheading ``Stop use and ask a doctor if'' and provides information on 
any signs of toxicity or other reactions that would necessitate 
immediately discontinuing use of the product. Lil' stated that, based 
on the dosing limitations of convenience-size packages, this 
information could be adequately addressed inside the carton.
    FDA generally agrees. Most of the signs of toxicity described in 
this section are expected to occur when the product has been used for 
more than one or two doses. However, for some products, this section 
requires a specific warning about potential allergic reactions that 
could occur even after one or two doses and informs consumers to seek 
medical help right away. FDA believes this allergy warning information 
describes a condition that may be serious and that could influence a 
consumer's decision at the point of purchase. Therefore, FDA is 
requiring that any warning information about allergic reactions 
required under this subheading must continue to appear on the outside 
package.
    5. Section 201.66(c)(5)(viii): This section requires warnings that 
do not fit within one of the paragraphs in Sec.  201.66(c)(5)(i) 
through (c)(5)(vii), (c)(5)(ix), and (c)(5)(x). An example of such a 
warning is ``* * * Do not puncture or incinerate. * * *'' for drugs in 
dispensers pressurized by gaseous propellants set forth in 21 CFR 
369.21. Lil' suggested that this section could be addressed case-by-
case using the same criteria as used for the other sections. FDA 
believes that there is little labeling in this category that would 
apply to convenience-size packages and that most, if not all, of the 
information that would appear under this heading could appear on the 
inside package labeling. There may be instances, perhaps in the future, 
in which a warning required under this section should appear on the 
outside Drug Facts label. FDA invites specific comment on which 
warnings included in this category, if any, should be kept on the 
outside package and how FDA should address the importance of future 
warnings required under this section.
    6. Section 201.66(c)(5)(ix): This section requires the pregnancy/
breast-feeding warning set forth in Sec.  201.63(a) and the third 
trimester warning set forth in Sec.  201.63(e) or in certain approved 
drug applications. Lil' acknowledged that this information should 
continue to appear on the external package labeling. FDA concurs that 
this information is needed at the point of purchase and must appear in 
the outer package labeling.
    7. Section 201.66(c)(5)(x): This section requires the warning to 
``Keep out of reach of children'' and the accidental overdose/ingestion 
warnings set forth in Sec.  330.1(g). Lil' provided a number of reasons 
why this information could appear inside the package. Lil' stated that 
convenience-size OTC products are usually not purchased, taken home, 
and stored. Instead, said Lil', they are usually consumed shortly after 
purchase to satisfy a consumer's immediate need. Lil' added that it is 
not industry practice to sell OTC drug products to children, which 
reduces the likelihood of a child possessing a convenience-size 
package. Finally, Lil' asserted an overdose is extremely unlikely given 
the dosing limitations in a ``convenience-size'' package.
    FDA agrees. Under Sec.  330.1(g), FDA has authority to grant an 
exemption from these warnings where appropriate upon petition. FDA is 
not inclined to use this authority to exempt convenience-size products 
from these warnings altogether. However, we are proposing to allow 
these warnings to appear inside OTC convenience-size packages on either 
an insert or inner-package labeling.
    8. Section 201.66(c)(6): This section requires the Drug Facts 
labeling to include the directions for use described in an applicable 
OTC drug monograph or approved drug application. The regulations in 21 
CFR 201.5 describe adequate directions for use for drugs as 
``directions under which the layman can use a drug safely and for the 
purposes for which it is intended.'' Directions can include: Uses of 
the drug; quantity of the dose (based on age); frequency, duration, 
time, and route or method of administration; preparation for use (i.e., 
shaking, dilution).
    Lil' stated that, for one- or two-dose products, having the 
directions for use at the point of purchase is less important because 
of the following:
     The package will not contain enough product for continued 
dosing and overdose, and
     The consumer's likely intent is to take the product 
immediately.
    FDA believes that for all OTC drugs, including convenience-size 
packages, it is preferable for all of the directions information to 
appear in one location to best inform consumers how to use the product. 
Because the directions may be lengthy, FDA is proposing that this 
information appear in full on the inside package labeling for OTC 
convenience-size drug products. However, FDA believes that it is 
important to inform consumers that the directions are inside the 
package. In addition, FDA believes that it is also important to inform 
consumers at the point of purchase that the product is not intended for 
use in certain age groups. Therefore, FDA is proposing that the 
following information appear in the outer package labeling in 7-point 
bold type size under the heading Directions: ``See inside for 
directions. This product is not for children under [insert appropriate 
age] without asking a doctor.'' FDA believes this approach strikes a 
balance between package size and the need for information about age 
limitations at the point of purchase. This will also enable consumers 
to make appropriate purchase decisions at the point of purchase and use 
OTC convenience-size packages safely for their intended purposes.
    9. Section 201.66(c)(7): This section requires, under the heading 
``Other information,'' additional information that is not included 
under Sec.  201.66(c)(2) through (c)(9), but which is required by or is 
made optional under an applicable OTC drug monograph, other OTC drug 
regulation, or is included in the labeling of an approved drug 
application. Examples include: (1) Required information about certain 
ingredients in OTC drug products (e.g., sodium in Sec.  201.64(c)), (2) 
phenylalanine/aspartame content required by Sec.  201.21(b), if 
applicable, and (3) additional information authorized to appear under 
this heading, such as the storage temperature and tamper evident 
statement. Lil' suggested that any reference to sodium, aspartame, or 
other special ingredients still appear on the outer labeling, while all 
other statements in this section appear on the inside package labeling. 
Lil' noted that the contents of convenience-size packages are 
customarily consumed upon purchase, lessening the need for storage and 
temperature warnings.
    FDA agrees with Lil', except for the location of the tamper evident 
statement. The regulations in 21 CFR

[[Page 74479]]

211.132(c) require the tamper-evident statement to be prominently 
placed on the package in such a manner that it will be unaffected if 
the tamper-evident feature of the package is breached or missing. To 
meet this requirement, FDA has determined that the tamper-evident 
statement must appear on the outer package labeling. However, the 
tamper-evident statement is not required to appear within the Drug 
Facts portion of the labeling and may appear elsewhere on the outer 
packaging.
    10. Section 201.66(c)(9): This section requires the heading 
``Questions or Comments,'' followed by the telephone number of a source 
to answer questions on the product. Lil' stated that, presumably, this 
section is related to questions and comments about continued 
consumption of a product. Given the one- and two-dose limitation and 
the consumer's usual intent for immediate consumption of the product, 
Lil' contended that this section may be adequately presented inside the 
package. FDA agrees that this information may appear on the inside 
labeling of the package.

D. Package Inserts and Inner-Labeling

    FDA is also considering different ways to present the Drug Facts 
labeling inside the package. Currently, FDA favors the following 
options: (1) A package insert that contains complete Drug Facts 
labeling in accord with Sec.  201.66(d)(1) through (d)(9), including 
all the information exempted from the outside labeling under proposed 
Sec.  201.66(b)(5) and (d)(11); or (2) permitting the Drug Facts 
labeling that is not required to appear on the outside container or 
wrapper to be printed on the inside of the outer container or wrapper 
in the required Drug Facts order. FDA believes the package insert 
containing the complete Drug Facts labeling is the preferred approach 
because it will be complete and less confusing to consumers. However, 
FDA is aware that information can be printed on the inside of cardboard 
and other containers, and Lil' mentioned inner-package printing as a 
possible approach. FDA's major concern about labeling appearing on the 
inside of the outer container or wrapper is whether consumers can (or 
will) open the package without tearing the part that contains the 
labeling, and the ease with which the information can be read once the 
outer container or wrapper is opened. FDA believes if this second 
option is allowed, it should be conditioned upon the package having an 
easy way to be opened (e.g., a pull tab), so that when the package is 
opened, the inside labeling information is readily exposed and can be 
easily read. FDA invites specific comment on the comparative costs of 
these methods of providing labeling inside the outer container, and 
whether there are packaging techniques readily available that would 
allow for these convenience-size packages to be easily opened without 
tearing the part of the package that contains labeling information. FDA 
also invites comment on other ways that Drug Facts labeling information 
could be presented inside a convenience-size package and comparative 
costs with the two methods discussed above.

E. Information Available on the Outside Container or Wrapper

    FDA discusses in section II of this document its basis for 
proposing to modify labeling for convenience-size OTC drug packages. 
FDA believes that convenience-size OTC drug packages, as defined by 
limited dose and container size in section III of this document, can 
adequately meet public health needs without presenting on the outer 
package all of the information required by the Drug Facts Rule. FDA 
does not believe that such modifications can be justified for larger 
packages, which contain enough medication for repetitive dosing and/or 
have sufficient available labeling space to bear all of the information 
required under the Drug Facts Rule. FDA is seeking feedback about 
whether the information proposed for the outer package, and available 
at the time of purchase, is adequate to support safe and effective use 
of the dose of medication to be allowed in a convenience-size OTC drug 
package. FDA is seeking comment on whether there should be an 
additional requirement that provides for full product information to be 
available at the point of purchase (e.g., a shelf-talker or extender, 
or a tear-off Drug Facts information sheet) if some of the Drug Facts 
information is not available on the outer package.

F. Summary of Optional Alternative Labeling for Convenience-Size 
Packages

    In summary, based on the previous discussion, it is FDA's view that 
as much of the Drug Facts labeling as possible should appear on the 
outside container or wrapper of convenience-size packages and be 
available to consumers at the point of purchase. FDA recommends that, 
when possible, manufacturers of convenience-size OTC drug packages as 
described in proposed Sec.  201.66(b)(5) try to fit all of the Drug 
Facts labeling on the outer container or wrapper using the modified 
format currently available in Sec.  201.66(d)(10). However, given the 
unique status of convenience-size OTC drug products--including the 
reduced risks associated with their limited contents, the ``size 
sensitive'' retail setting in which they are sold, and the fact that 
many are purchased for immediate consumption--FDA is proposing to allow 
certain Drug Facts information to appear inside a convenience-size OTC 
drug package. Accordingly, FDA is proposing a new Sec.  201.66(d)(11) 
(existing Sec.  201.66(d)(11) is being redesignated as Sec.  
201.66(d)(12)) to state that OTC drug products that meet the 
convenience-size package definition in Sec.  201.66(b)(5) may use an 
optional alternative version of the Drug Facts labeling in which 
certain information otherwise required to appear on the outside wrapper 
or container of an OTC drug product under Sec.  201.66(c)(5)(vi), 
(c)(5)(vii), (c)(5)(viii), (c)(5)(x), (c)(6), (c)(7), and (c)(9) may 
appear inside the package. FDA further proposes, under Sec.  
201.66(d)(11), that the Drug Facts labeling on the outside container or 
wrapper contain the statement ``See information inside before using,'' 
in bold italic type no smaller than 7-point size. This statement would 
appear either immediately after and on the same line as the ``Drug 
Facts'' title, or immediately beneath the ``Drug Facts'' title and 
above the horizontal hairline that would otherwise immediately follow 
the ``Drug Facts'' title. FDA is also proposing that the following 
information appear in the outer package labeling in 7-point bold type 
size under the heading Directions: ``See inside for directions. This 
product is not for children under [insert appropriate age] without 
asking a doctor.'' FDA invites specific comment on this wording and 
format and other wording or formats that would convey the same message.
    FDA is also considering different ways to present the exempted Drug 
Facts labeling inside the OTC drug package. Currently, FDA favors the 
following options: (1) A package insert that contains complete Drug 
Facts labeling in accord with Sec.  201.66(d)(1) through (d)(9), 
including all the information exempted from the outside labeling under 
proposed Sec.  201.66(b)(5) and (d)(11); or (2) permitting the Drug 
Facts labeling that is not required to appear on the outside container 
or wrapper to be printed on the inside of the outer container or 
wrapper in the required Drug Facts order.

IV. Legal Authority

    This rule, if finalized, would not require OTC drug product 
labeling to bear new kinds of information. Rather, the rule would 
modify the format of the current OTC Drug Facts labeling to

[[Page 74480]]

accommodate the unique circumstances associated with the packaging, 
marketing, purchase, and use of ``convenience size'' OTC drug packages.
    FDA's legal authority to modify Sec.  201.66 arises from the same 
authority under which FDA initially issued the regulation, including 21 
CFR parts 201, 301, 502, 505, 507, and 701 of the act. This authority 
is described in detail in the Federal Register of February 27, 1997 (62 
FR 9042 through 9043).

V. Analysis of Impacts

    The economic impact of the Drug Facts Rule was discussed in the 
final rule (64 FR 13254 at 13276). That discussion included estimates 
of the increased costs for small package products that could not fit 
the new Drug Facts labeling to enlarge the package or to use other 
labeling techniques (e.g., risers) to fit the information. FDA 
estimated that 6.4 percent of all shelf-keeping units (SKUs) had labels 
that either would not fit or were indeterminate (too close to call) 
and, thus, might require a new packaging configuration to accommodate 
the new format (64 FR 13254 at 13283). Convenience size packages were 
included in the estimate, as well as other small package sizes. The 
Consumer Healthcare Products Association has stated that ``convenience-
sizes'' represent less than 1 percent of the retail market (Ref. 3).
    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, 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). Under the Regulatory 
Flexibility Act, if a rule has a significant economic impact on a 
substantial number of small entities, FDA 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 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 has concluded that this proposed rule is consistent with the 
principles set out in Executive Order 12866 and in these two statutes. 
This proposed 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 
proposed rule will not have a significant economic impact on a 
substantial number of small entities. The Unfunded Mandates Reform Act 
does not require FDA to prepare a statement of costs and benefits for 
this proposed rule, because the proposed rule is not expected to result 
in any 1-year expenditure that would exceed $100 million adjusted for 
inflation. The current threshold after adjustment for inflation is $115 
million, using the most current (2003) Implicit Price Deflator for the 
Gross Domestic Product.
    The purpose of this proposed rule is to define OTC ``convenience-
size'' drug products and to provide Drug Facts labeling alternatives 
for these products that would enable manufacturers, repackers, or 
distributors to provide certain labeling information on the inside of 
the package, either in a package insert or by internal package 
printing. This alternative approach would apply only to packages that 
meet the proposed package size and dose limitations. The economic 
impact for relabeling OTC drug products was previously addressed in the 
final rule. This proposed rule provides an alternative labeling 
approach to accommodate the Drug Facts labeling requirements.
    In the final rule (64 FR 13254 at 13283), FDA estimated 4.5 percent 
of all OTC drug SKUs may require increased package sizes to accommodate 
the new Drug Facts format. The one-time cost to industry was about 
$38.1 million and the annually recurring costs were estimated to be 
$11.5 million for the added package and label materials (64 FR 13254 at 
13284). The cost analysis included a number of alternative package 
configurations, including adding an outer carton, a fifth panel (a back 
panel), enlarging the package, and adding a peel-back or two-ply label 
using existing or retooled packaging lines. Package inserts or double-
sided printing were not considered in that analysis. In some 
circumstances these two alternatives could be less costly than the 
others included in the analysis. This proposed rule allows 
manufacturers additional flexibility to choose the least costly 
packaging alternative to meet their marketing requirements but would 
probably have little effect on the overall cost of relabeling. In the 
original analysis FDA did not identify which of the small package sizes 
that could not accommodate the Drug Facts format would be considered 
convenience sized packages. As such, we cannot breakout the estimated 
costs from the Drug Facts Rule (64 FR 13254 at 13276 to 13285) that 
applied to convenience-sized packaged products.
    Because this proposed rule does not mandate changes to packaging, 
but increases manufacturers choice of package configurations FDA 
certifies that this proposed rule will not have a significant economic 
impact on a substantial number of small entities. No further analysis 
is required.

VI. Paperwork Reduction Act of 1995

    FDA tentatively concludes that the proposed 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 proposed labeling requirements 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)).

VII. 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.

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized as proposed, would have a pre-emptive 
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 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 act (21 U.S.C. 379r) is an express pre-
emption provision. Section 751(a) of the act 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

[[Page 74481]]

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 pre-empt States from imposing 
requirements related to the regulation of nonprescription drug 
products. (See section 751(b), (c), (d), and (e) of the act for the 
scope of the express pre-emption provision, the exemption procedures, 
and the exceptions to the provision.) This proposed rule, if finalized 
as proposed, would amend the format and content requirements for the 
labeling for OTC convenience size drug packages. Although any final 
rule would have a pre-emptive effect, in that it would preclude States 
from issuing requirements related to the labeling of OTC convenience 
size 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. FDA also notes 
that even where the express pre-emption provision is not applicable, 
implied preemption may arise (See Geier v. American Honda Co., 529 US 
861 (2000)).
    FDA believes that the pre-emptive effect of the proposed rule, if 
finalized as proposed, 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.'' FDA is providing an opportunity for State and local 
officials to comment on this rulemaking.

IX. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document 
and FDA's economic impact determination. Three copies of all written 
comments are to be submitted. Individuals submitting written comments 
or anyone submitting electronic comments may submit one copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document and may be accompanied by a supporting 
memorandum or brief. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

X. Proposed Effective Date

    FDA is proposing that any final rule that may issue based on this 
proposal for OTC convenience-size drug products become effective 18 
months after its date of publication in the Federal Register. FDA is 
proposing that the compliance date for OTC convenience-size drug 
products with annual sales less than $25,000 would be 24 months after 
the date of publication in the Federal Register. The compliance date 
for all other OTC convenience-size drug products would be 18 months 
after the date of publication in the Federal Register.

XI. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Comment No. CP1, Docket Number 2001P-0207.
    2. Letter from S. Galson, FDA, to J. M. Nikrant, Lil' Drug Store 
Products, Inc., coded LET 1, Docket Number 2001P-0207.
    3. Letter from R. W. Soller, CHPA, to C. Ganley, FDA, dated October 
3, 2000, Docket Number 1998N-0337.

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, it is 
proposed that 21 CFR part 201 be 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 201.66 is amended by redesignating paragraphs (b)(5) through 
(b)(12) as paragraphs (b)(7) through (b)(14), respectively, and by 
redesignating paragraph (d)(11) as paragraph (d)(12), and by adding new 
paragraphs (b)(5), (b)(6), and (d)(11) to read as follows:


Sec.  201.66   Format and content requirements for over-the-counter 
(OTC) drug product labeling.

* * * * *
    (b) * * *
    (5) Convenience-size package means a package containing no more 
than two doses, as defined in paragraph (b)(6) of this section, of an 
OTC drug product that, because of its limited available labeling space, 
both qualifies for the modified labeling set forth in paragraph (d)(10) 
of this section and would require more than 60 percent of its total 
surface area available to bear labeling to meet the labeling 
requirements set forth in paragraph (d)(10). This definition does not 
include OTC drug packages that contain ipecac syrup or activated 
charcoal.
    (6) Dose means a maximum single-serving for an adult (or child for 
products marketed only for children) as specified in the product's 
directions for use. For products marketed with directions for use for 
both adults and children, dose means a maximum single serving for a 
child as specified in the product's direction for use.
* * * * *
    (d) * * *
    (11) Convenience-size packages. The labeling of products that meet 
the convenience-size package definition in paragraph (b)(5) of this 
section shall appear in accord with either paragraph (d)(10) or 
paragraph (d)(11)(i) of this section.
    (i) The outside container or wrapper of an OTC convenience-size 
drug product labeled under this section shall comply in all respects 
with paragraph (d)(10) of this section, except as modified by 
paragraphs (d)(11)(i)(A) through (d)(11)(i)(G) and paragraph 
(d)(11)(ii) of this section.
    (A) All information required by paragraph (c)(5)(vi) of this 
section, including the statement ``do not use more than directed,'' may 
appear on the inside of the OTC drug package in accord with paragraph 
(d)(11)(ii) of this section, except any information about potential 
drowsiness, avoiding alcohol, and using caution when driving a motor 
vehicle or operating machinery, which shall appear on the outside 
container or wrapper in accord with paragraph (d)(10) of this section.
    (B) All information required by paragraph (c)(5)(vii) of this 
section may appear on the inside of the OTC drug package in accord with 
paragraph (d)(11)(ii) of this section, except any information about a 
potential allergic reaction, which shall appear on the outside 
container or wrapper in accord with paragraph (d)(10) of this section.
    (C) All information required by paragraph (c)(5)(x) of this 
section, including the statement ``Keep out of reach of children'' and 
the accidental overdose/ingestion warnings set forth

[[Page 74482]]

under Sec.  330.1(g) of this chapter, may appear on the inside of the 
OTC drug package in accord with paragraph (d)(11)(ii) of this section.
    (D) All information required by paragraph (c)(6) of this section 
may appear on the inside of the OTC drug package in accord with 
paragraph (d)(11)(ii) of this section. If any such information is 
placed inside the package, the outside container or wrapper shall state 
the following in bold italic type no smaller than 7-point under the 
heading ``Directions'': ``See inside for directions. This product is 
not for children under [insert appropriate age] without asking a 
doctor.''
    (E) All information required by paragraph (c)(7) of this section 
may appear on the inside of the OTC drug package in accord with 
paragraph (d)(11)(ii) of this section, except: the tamper evident 
statement required by Sec.  211.132(c), which must appear on the 
outside container or wrapper, but need not necessarily appear in the 
Drug Facts box or similar enclosure; andall information required by 
paragraphs (c)(7)(i) and (c)(7)(ii) of this section, which shall appear 
on the outside container or wrapper in accord with paragraph (d)(10) of 
this section.
    (F) All information required by or authorized under paragraph 
(c)(9) of this section may appear on the inside of the OTC drug package 
in accord with paragraph (d)(11)(ii) of this section.
    (G) In the event that any information is placed inside an OTC drug 
package under the authority of paragraphs (d)(11)(i)(A) through 
(d)(11)(i)(G), the outside container or wrapper of that package shall 
state the following in bold italic type no smaller than 7-point: ``See 
information inside before using.'' This statement shall appear either 
immediately after and on the same line as the ``Drug Facts'' title or 
immediately beneath the ``Drug Facts'' title and above the horizontal 
hairline that would otherwise immediately follow this title.
    (ii) Any and all labeling included inside any OTC drug package or 
wrapper to comply with any provision of paragraph (d)(11)(i) of this 
section shall appear in one and only one of the following ways:
    (A) In a package insert that contains the complete Drug Facts 
labeling as defined in paragraph (b)(12) of this section printed in 
accordance with the specifications in paragraphs (d)(1) through (d)(9) 
of this section, regardless of whether some of this information also 
appears on the outside container or wrapper; or
    (B) All Drug Facts labeling as defined in paragraph (b)(12) of this 
section that does not appear on the outside container or wrapper shall 
be printed on the inside of the outside container or wrapper in the 
order listed in paragraph (d)(11) of this section and shall appear in 
accordance with the specifications in paragraphs (d)(1) through (d)(9) 
or in paragraph (d)(10). The title ``Drug Facts (continued)'' shall 
appear at the top of each subsequent panel containing such information. 
When any Drug Facts labeling is printed on the inside of the outside 
container or wrapper, the container or wrapper shall have an easy way 
to be opened (e.g., a pull tab or something similar) so that the 
package or wrapper on which the information is printed is unlikely to 
be torn or destroyed, and the labeling information is readily exposed 
and can be easily read.

    Dated: November 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21019 Filed 12-11-06; 8:45 am]
BILLING CODE 4160-01-S