[Federal Register Volume 66, Number 149 (Thursday, August 2, 2001)]
[Rules and Regulations]
[Pages 40111-40116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19225]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Child-Resistant Packaging for Certain Over-The-Counter Drug 
Products

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: Pursuant to its 3-0 vote to do so, the Consumer Product Safety 
Commission (CPSC or Commission) is issuing a rule to require child-
resistant (CR) packaging on drugs (OTC switched drugs) approved by the 
Food and Drug Administration (FDA) for over-the-counter (OTC) sale that 
contain active ingredients previously available only in prescription 
drugs. Current Commission regulations require CR packaging for most 
oral drug products containing prescription-only active ingredients. 
However, prior to issuance of this rule there was no general 
requirement to maintain CR packaging of such drug products in forms 
subsequently approved by the FDA for OTC sale.
    The Commission is also revoking the current prohibition on granting 
a petition for an exemption from a CR packaging requirement prior to 
FDA approval of the drug product in question.
    The Commission takes these actions under authority of the Poison 
Prevention Packaging Act of 1970, as amended.

DATES: The rule will become effective on January 29, 2002, and applies 
only to products for which the new drug application (NDA) or 
abbreviated new drug application (ANDA) for the OTC switch is submitted 
to the FDA on or after that date.

FOR FURTHER INFORMATION CONTACT: Suzanne Barone, Ph.D., Directorate for 
Health Sciences, Consumer Product Safety Commission, Washington, D.C. 
20207; telephone (301) 504-0477 ext. 1196 or Geri Smith, Office of 
Compliance, Consumer Product Safety Commission, Washington, D.C. 20207; 
telephone (301) 504-0608 ext. 1160.

SUPPLEMENTARY INFORMATION:

A. Background

1. Prior Regulatory Approach

    The Poison Prevention Packaging Act of 1970 (PPPA), 15 U.S.C. 1471-
1476, was established to protect children from serious personal injury 
or serious illness resulting from handling, using, or ingesting 
hazardous substances. Under the PPPA, the CPSC can require child-
resistant packaging of hazardous household chemicals, including drugs. 
The CPSC currently requires child-resistant packaging of oral 
prescription medications, unless they have been specifically exempted 
from the packaging requirements. 16 CFR 1700.14(a)(10). In contrast, 
OTC drugs, which are also called nonprescription drugs because they can 
be sold to consumers without prescription by a licensed medical 
practitioner, have not previously been regulated as a class under the 
PPPA.
    Regulations have been issued to require child-resistant packaging 
of several individual OTC products including diphenhydramine, 
ibuprofen, loperamide, naproxen, and ketoprofen. These oral drugs were 
available originally only by prescription and therefore required child-
resistant packaging under the oral prescription drug regulation. The 
FDA subsequently granted OTC status to these drugs, thus removing them 
from the scope of the child-resistant packaging requirements of the 
oral prescription drug regulation. After each of these substances was 
granted OTC status, the Commission promulgated a separate regulation to 
require the child-resistant packaging of the drug.

2. Relevant Statutory and Regulatory Provisions

    The PPPA authorizes the Commission to establish standards for the 
``special packaging'' of any household substance if: (1) The degree or 
nature of the hazard to children in the availability of such substance, 
by reason of its packaging, is such that special packaging is required 
to protect children from serious personal injury or serious illness 
resulting from handling, using, or ingesting such substance; and (2) 
the special packaging is technically feasible, practicable, and 
appropriate for such substance. 15 U.S.C. 1472(a).
    CR or ``special'' packaging must be designed or constructed to be: 
(1) Significantly difficult for children under 5 years of age to open 
or obtain a toxic or harmful amount of the substance contained therein 
within a reasonable time; and (2) not difficult for ``normal

[[Page 40112]]

adults'' to use properly. 15 U.S.C. 1471(4). Household substances for 
which the Commission may require CR packaging include (among other 
categories) foods, drugs, or cosmetics as these terms are defined in 
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321. 15 U.S.C. 
1471(2)(B). The Commission has promulgated performance requirements for 
special packaging. 16 CFR 1700.15 and 1700.20.
    Section 4(a) of the PPPA, 15 U.S.C. 1473(a), allows the 
manufacturer or packer to package a nonprescription product subject to 
special packaging standards in one size of non-CR packaging only if the 
manufacturer (or packer) also supplies the product in a CR package of a 
popular size, and the non-CR package bears conspicuous labeling stating 
``This package for households without young children.'' 15 U.S.C. 
1473(a), 16 CFR 1700.5.

3. The Proposed Rule

    On August 30, 2000, the Commission issued a notice of proposed 
rulemaking (NPR) that would require that CR packaging requirements 
applicable to an oral prescription drug product continue to apply when 
that drug product or any other drug product containing an active 
ingredient of that product is granted OTC status by the FDA. 65 FR 
52678. The proposed rule would require that the new use or new dose be 
sold in CR packaging even if the new use or dose was not approved when 
the drug product was only available by prescription. This is consistent 
with the current regulatory approach for a new use for an oral OTC 
product that is already subject to a CR packaging requirement.
    The proposed rule would not extend CR packaging requirements to 
OTC-switched products that are not oral formulations, even if they 
contain any of the same active ingredients as an oral preparation.
    The proposed rule would require CR packaging for any OTC oral drug 
product containing an active ingredient that was available by 
prescription even if the OTC dosage is lower than the prescription 
strength. This recognizes the reality that absent CR packaging, the 
``dose'' potentially available to a child is the entire package 
contents.

4. Exemptions

    An exemption procedure exists for PPPA-regulated products that do 
not pose a risk of serious injury or illness to children or for which 
CR packaging is not technically feasible, practicable, or appropriate. 
16 CFR part 1702. Under the proposed rule, this exemption procedure 
would remain available to manufacturers of OTC-switched products.
    The proposed rule would revoke 16 CFR 1702.16(b) so that exemption 
petitions can be submitted and considered by the Commission earlier in 
the process, i.e., before FDA approval. This would enable manufacturers 
to seek an exemption from the CR packaging requirements and have a 
Commission decision prior to submitting an application to the FDA for 
approval of an OTC or prescription drug product.
    To assist consumers and industry in identifying which OTC-switched 
drug products require CR packaging, the preamble to the proposal 
indicated that the Commission intended to maintain a list of OTC-
switched drug products subject to the regulation as an appendix to the 
regulations at 16 CFR 1700.14.

B. Response to Comments

    Five comments were received in response to the NPR. Three of the 
five comments received supported the rule as proposed (CP01-1, 2, 5).
    Comment: Several commenters questioned whether the PPPA permits 
imposing child-resistant packaging requirements on a category of drugs 
and then placing the burden on a manufacturer to seek exemption of 
individual drugs. (CP01-1-3, 4)
    Response: The PPPA authorizes regulation of a category of 
substances where the required findings can be made for that category. 
In fact, a number of entries under the CPSC regulation imposing the 
PPPA child-resistant packaging requirement, 16 CFR 1700.14(a), are 
defined as broad categories. (See, for example: controlled drugs--``any 
preparation for human use that consists in whole or in part of any 
substance subject to control under the Comprehensive Drug Abuse 
Prevention and Control Act * * *,'' (16 CFR 1700.14(a)(4); prescription 
drugs--``any drug for human use that is in a dosage form intended for 
oral administration * * *,'' (16 CFR 1700.14(a)(10)).
    All members of the class that would be required to be in child-
resistant packaging by an OTC-switch rulemaking were previously covered 
by the PPPA child-resistant packaging requirement for oral prescription 
drugs (16 CFR 1700.14(a)(10)). The statutory findings for that class 
were made by the FDA in the 1972-1973 rulemaking that imposed child-
resistant packaging on oral prescription drugs. 38 FR 9431 (April 16, 
1973).
    The ability of a drug to cause serious injury to a child does not 
change when it is sold OTC. Child-resistant packaging remains 
technically feasible, practicable, and appropriate for the OTC version, 
just as was the case when it was required for the prescription 
formulation. Furthermore, the continued need for child-resistant 
packaging is not a factor considered by the FDA when making its 
decision to approve the switch of a drug from prescription to OTC 
status. Under the OTC-switch rule as proposed, and as issued in final 
form today, the responsibility/burden on a manufacturer to justify an 
exemption for an OTC-switched drug via the procedures of 16 CFR 1702 is 
the same as it was before the drug was switched.
    The courts have typically approved the validity of regulatory 
schemes where a rule addresses a general situation that is too complex 
for the rule to be appropriate in every instance, but where an 
exemption procedure is established to deal with special situations. 
See, e.g., United States v. Allegheny-Ludlum Steel Corp., 406 U.S. 742 
(1972); see also Phillips Petroleum Co. v. EPA, 803 F.2d 545, 562 (10th 
Cir. 1986)(upholding a regulation applying a ``generic streamlined 
approach or procedure'' on the grounds of ``feasibility and 
practicality'' where the plaintiff argued that the statute required a 
case-by-case review).
    In a case that addressed the Commission's Flammable Fabrics Act 
regulatory authority, which is analogous to that under the PPPA, the 
First Circuit affirmed the categorical approach to regulation. Bunny 
Bear v. Peterson, 473 F.2d 1002 (1st Cir. 1973). The Bunny Bear court 
also addressed the ``burden'' issue by stating that when the regulatory 
agency ``plausibly opts for the inclusion of a particular product [in a 
regulatory scheme], it is not unreasonable to require affected 
manufacturers to point out with particularity those features which make 
special treatment [i.e., exemption] necessary.'' Bunny Bear at 1007.
    Comment: One commenter requested that OTC products be available in 
both child-resistant packaging and non child-resistant packaging for 
the elderly and disabled (CP01-1).
    Response: The PPPA provides for the use of both child-resistant and 
non child-resistant packaging. Section 4 of the Act allows 
manufacturers to package a product in one size that does not meet the 
child-resistant packaging standards. 15 U.S.C. 1473. A product so 
packaged must carry a labeling statement warning that it is not 
recommended for use in households with young children. There is no 
requirement that manufacturers have a non child-resistant size.
    It is the manufacturer's decision whether or not to market a

[[Page 40113]]

noncomplying size. Manufacturers who market one size of their product 
in non child-resistant packaging must also supply the product in 
popular-sized packages that are child-resistant. If the manufacturer 
does not comply with this provision, the Commission can require that 
the product be packaged exclusively in child-resistant packaging. 15 
U.S.C. 1473(c).
    Child-resistant packaging has also become more ``adult-friendly.'' 
In 1995 the Commission issued a revised test method that tests 
participants aged 50 to 70, rather than 18 to 45 years of age, to 
ensure that most adults can use child resistant packaging properly. 16 
CFR Sec. 1700.20(a)(3)(i).
    Comment: One commenter requested that manufacturers and sellers 
have 18-months advance notice of the effective date of these packaging 
changes and that they only be implemented for newly manufactured 
packages (CP01-2).
    Response: The packaging regulation as proposed and as issued in 
final form applies only to a drug granted OTC status as a result of a 
new drug applications (NDA) or abbreviated new drug application (ANDA) 
submitted to the FDA on or after the effective date of the final OTC-
switch rule. The rule does not affect any product that is approved for 
OTC sale before that date. The rule does not impact the current 
production or sale of previously switched products. Therefore the 
effective date of 180 days after issuance of a final rule should be 
adequate for companies currently preparing NDA or ANDA submissions 
requesting OTC status for oral prescriptions.
    Comment: One commenter requested that a comprehensive list of 
affected products and ingredients be made available in advance of the 
effective date (CP01-2).
    Response: The CPSC will publish a list of drugs that are affected 
by the rule as soon as the Agency becomes aware of them. CPSC will work 
with the FDA to obtain timely notification of approval of oral 
prescription drugs that are granted OTC status. No oral prescription 
drug approved for OTC sale (or for which the NDA or ANDA for an OTC 
switch was submitted) before the effective date is affected by the 
rule. The list will include only OTC switched drugs for which the NDA 
or ANDA was submitted on or after the effective date of the final rule.
    Comment: One commenter questioned the efficiency of the proposed 
rule in saving staff resources because of the resources potentially 
needed to consider requests for exemptions. The commenter stated that 
it may be just as efficient to continue the practice of considering the 
need for child-resistant packaging on a case-by-case basis (CP01-3).
    Response: The primary goal of this rulemaking is not to save staff 
resources but to continue to protect children from serious injury from 
ingesting oral prescription drugs that are granted OTC status and 
become widely available. This rule eliminates the potential for newly 
switched oral OTC drugs to be packaged and sold without child-resistant 
packaging before a decision concerning the continued need for child-
resistant packaging is made by the Commission. Furthermore, these drugs 
were already required to be in child-resistant packaging in their 
prior, prescription-only form. Finally, it is worth noting that some 
companies already voluntarily use child-resistant packaging for their 
``OTC switched'' products.
    The staff cannot estimate how many petitions for exemption from the 
child-resistant packaging requirements the Commission will receive.
    Comment: Two commenters requested revisions to the Commission's 
PPPA regulations that define child-resistant unit packaging (CP01-3, 
4).
    Response: The child-resistant unit packaging regulations are not 
part of this rulemaking. Therefore the comment is beyond the scope of 
this rulemaking. Accordingly, the Commission is not required to respond 
to it. See, e.g., American Iron & Steel Institute v. EPA, 886 F.2d 390, 
398 (D.C. Cir. 1989), cert. denied, 497 U.S. 1003 (1990).
    Comment: One commenter requested clarification that the Commission 
will accept and act on a petition for exemption early in the process, 
before a NDA or ANDA is submitted to the FDA.
    Response: In the preamble to the proposed rule, the Commission 
stated that, ``* * * the Commission is proposing to revoke 16 CFR 
1702.16(b) so that exemption petitions can be submitted and considered 
by the Commission earlier in the process, i.e., before FDA approval. 
This would enable manufacturers to seek an exemption from the child-
resistant packaging requirements and have a Commission decision prior 
to submitting an application to the FDA for approval of an OTC or 
prescription drug product.'' 65 FR 52682. Since 16 CFR 1702.16(b) is 
revoked by today's rule, there is no longer any restriction on the 
timing of Commission consideration of a petition for exemption from an 
otherwise applicable child-resistant packaging requirement.
    The exemption process involves rulemaking. This process can be 
expedited if the manufacturer meets with the CPSC staff to discuss the 
process before filing a petition for exemption with the Commission as 
outlined in 16 CFR part 1702.
    Comment: One commenter expressed a concern that if a petition is 
submitted before the NDA is submitted, it could prematurely signal a 
company's business plans. They believed that a confidential exemption 
procedure might be necessary but stated the concern that it would not 
be compatible with the current rulemaking approach to exemptions. 
(CP01-3)
    Response: The commenter is correct that the child-resistant 
packaging exemption procedure involves public notice and comment. A 
petitioner must be willing to make toxicity and safety information 
available for Commission and public review.
    There are many factors that a company considers when deciding to 
pursue OTC status for an oral prescription drug. These may include 
safety of use and potential misuse, ability of a consumer to self-treat 
using the medication, or a new market for a drug at the end of its 
patent, etc. There is much speculation in the press about drugs that 
may be ``switched'' based upon these factors. The commenter (Consumer 
Healthcare Products Association) publishes a list of potential switches 
that have been named in the trade or popular press.\1\ The FDA 
requested comments and held a public meeting last year to discuss 
potential OTC drugs.\2\ Much of the discussion at the public hearing 
focused on classes of drugs that may or may not be appropriate for OTC 
sale.
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    \1\ Available on the CHPA website: www.chpa-info.org
    \2\ 65 FR 24704
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    A manufacturer of an oral prescription drug that is contemplating 
seeking approval for an OTC switch could request an exemption for the 
prescription drug. It is the active ingredient itself at a defined 
level that would then be exempted. Under the rule as proposed, an 
exempted oral prescription drug would remain exempted from child-
resistant packaging when it is granted OTC status. For example, if an 
oral contraceptive or colestipol were made available OTC, it would not 
require child-resistant packaging if the OTC preparation met the same 
conditions as the exempted oral prescription form. (16 CFR 
1700.14(a)(10)(iv) and (xv)). A manufacturer would still have the 
option of petitioning the Commission for exemption after the drug is 
approved for OTC sale.

[[Page 40114]]

C. Statutory Considerations

1. Hazard to Children

    Before issuing a rule requiring CR packaging, the Commission must 
find that the degree or nature of the hazard to children in the 
availability of OTC-switched drug products by reason of their packaging 
is such that special packaging is required to protect children from 
serious injury or illness from handling, using, or ingesting the drug 
products. 15 U.S.C. 1472(a)(1). These statutory findings were made when 
the rule requiring CR packaging for oral prescription drug products was 
promulgated in 1973. 38 Fed. Reg. 9431 (April 16, 1973).
    OTC-switches did not begin to occur until several years after the 
1973 rule requiring CR packaging for oral prescription drug products 
was promulgated. The first such switches were carried out in response 
to recommendations resulting from an FDA Advisory Panel's review of 
over-the-counter drug products.
    The need to continue to protect children remains when oral 
prescription drug products are granted OTC status. As noted previously, 
a decision by the FDA to grant OTC status for a prescription drug 
product is not a determination that there is no toxicity to a child if 
the drug product is accidentally ingested. The active ingredient(s) 
contained in the drug product have the same toxicity whether in 
prescription or OTC form. The issue is whether drug products switched 
to OTC status at a lower dosage than was available by prescription are 
still hazardous to young children. This is the case since absent CR 
packaging, the ``dose'' available to a child can be the entire contents 
of the OTC product package. The Commission's experiences with ibuprofen 
and naproxen demonstrate that toxic amounts of the active ingredients 
are available even when lower dosages are approved for OTC product 
sale.
    Another important consideration is that OTC drug products are more 
readily available to consumers and therefore more accessible to 
children than prescription products containing the same active 
ingredient(s). The Commission concludes that the available data support 
the finding that maintaining CR packaging is necessary to protect 
children from serious injury or illness from ingesting oral 
prescription drug products that have been granted OTC status.

2. Technical Feasibility, Practicability, and Appropriateness

    As a prerequisite to a CR packaging rule, the Commission must also 
find that the special packaging is ``technically feasible, practicable, 
and appropriate.'' 15 U.S.C. 1472(a)(2). Technical feasibility may be 
found when technology exists or can be readily developed and 
implemented by the effective date to produce packaging that conforms to 
the standards. Practicability means that special packaging complying 
with the standards can utilize modern mass production and assembly line 
techniques. Packaging is appropriate when complying packaging will 
adequately protect the integrity of the active ingredient(s) in the 
product and not interfere with its intended storage or use. See S. Rep. 
No. 91-845, at 10 (1970).
    In some cases the same packaging can be used for the OTC product as 
for the prescription product. However, companies must modify the labels 
since FDA labeling requirements for OTC drug products differ from the 
labeling requirements for prescription drugs. Also, most companies 
develop new packaging specifically for the OTC market. Unit dose 
packaging is popular for the OTC market, especially for drug products 
such as antihistamines that are sold in limited quantities. Other 
products containing active ingredients such as the anti-inflammatory 
compounds ibuprofen and naproxen are sold in bottles. CR designs of 
this sort of unit and reclosable packaging are commercially available. 
The change in status of the drug from prescription-only to OTC does not 
change the availability of the CR packaging in mass-produced 
quantities, or detract from its ability to maintain the shelf life of 
switched drug products. Therefore, the Commission concludes that CR 
packaging for OTC-switched drug products is technically feasible, 
practicable, and appropriate.

3. Other Considerations

    Section 3(b) of the PPPA requires that the Commission consider the 
following in establishing a special packaging standard:
    a. The reasonableness of the standard;
    b. Available scientific, medical, and engineering data concerning 
special packaging and concerning childhood accidental ingestions, 
illness, and injury caused by household substances;
    c. The manufacturing practices of industries affected by the PPPA; 
and
    d. The nature and use of the household substance. 15 U.S.C. 
1472(b).
    The Commission has considered these factors with respect to the 
various determinations made in this rulemaking, and finds no reason to 
conclude that the rule is unreasonable or otherwise inappropriate.

D. Applicability

    The packaging configuration for a drug product to be switched is 
determined before a company submits the NDA or the ANDA for the OTC-
switch to the FDA. Accordingly, this rule applies prospectively to drug 
products for which the application for the OTC-switch is submitted to 
the FDA on or after the effective date of the final rule (180 days 
after publication).

E. Effective Date

    The PPPA provides that no regulation shall take effect sooner than 
180 days or later than one year after the date such final regulation is 
issued, except that, for good cause, the Commission may establish an 
earlier effective date if it determines an earlier date to be in the 
public interest. 15 U.S.C. 1471n. The NPR proposed an effective date of 
180 days after publication of the final rule. The commenter suggesting 
a further delayed effective date seemed to believe that the proposed 
rule might apply to an oral prescription drug for which an NDA or ANDA 
had been submitted to the FDA prior to the effective date or for which 
the OTC switch had been approved by the FDA prior to the effective 
date. This is not the case. The rule as proposed and as issued today 
applies only to drugs for which the NDA or ANDA for the OTC switch is 
submitted on or after the effective date. Thus the final rule takes 
effect 180 days after publication.

F. Regulatory Flexibility Act Certification

    When an agency undertakes a rulemaking proceeding, the Regulatory 
Flexibility Act (RFA), as amended by the Small Business Regulatory 
Enforcement Fairness Act of 1996, 5 U.S.C. 601 et seq., generally 
requires the agency to prepare initial and final regulatory flexibility 
analyses describing the impact of the rule on small businesses and 
other small entities. Section 605 of the RFA provides that an agency is 
not required to prepare a regulatory flexibility analysis if the head 
of the agency certifies that the rule will not have a significant 
economic impact on a substantial number of small entities.
    The Commission's Directorate for Economic Analysis prepared an 
assessment of the impact of a rule to maintain CR packaging for OTC-
switched drug products. A copy of the analysis is available for 
inspection in

[[Page 40115]]

the docket for this rulemaking. The assessment reports that the 
incremental cost of providing basic CR packaging is usually small 
($0.005-$0.02/per package). The assessment notes that the incremental 
cost may be somewhat higher if the marketer elects to provide more 
elaborate packaging in an effort to create ``shelf appeal'' to attract 
consumers and compete with other OTC products in the same therapeutic 
category.
    Because these costs (if any) are likely to be passed on to 
consumers, it is unlikely that the rule will have a substantial effect 
on a significant number of small businesses.
    Many previously OTC-switched drug products are already sold in CR 
packaging. In some instances, for example with certain oral dosage 
formulations of acetaminophen, ibuprofen and loperamide, this is 
because the Commission has affirmatively required CR packaging. In 
other cases, the marketer has elected voluntarily to use CR packaging.
    This rule revokes the existing requirement at 16 CFR 1702.16(b) 
that new drug approval be obtained from the FDA prior to Commission 
approval of a petition seeking exemption from a CR packaging 
requirement. Allowing for advance consideration and approval of any 
legitimate CR packaging exemption petition should minimize or eliminate 
any unwarranted economic impact that would otherwise result from 
maintaining the CR packaging requirement on OTC-switched oral 
prescription drug products or from requiring a change to CR packaging 
post-marketing.
    Based on the foregoing assessment, the Commission certifies that 
this rule to maintain CR packaging for OTC-switched drug products does 
not have a significant impact on a substantial number of small 
businesses or other small entities.

G. Environmental Considerations

    Pursuant to the National Environmental Policy Act, and in 
accordance with Council on Environmental Quality regulations and CPSC 
procedures for environmental review, the Commission has assessed the 
possible environmental effects associated with the proposed PPPA 
requirements for OTC-switched drug products.
    The Commission's regulations state that rules requiring special 
packaging for consumer products normally have little or no potential 
for affecting the human environment. 16 CFR 1021.5(c)(3). Nothing in 
this rule alters that expectation. Therefore, because the rule would 
have no adverse effect on the environment, neither an environmental 
assessment nor an environmental impact statement is required.

H. Executive Order No. 12,988

    As provided for in Executive Order No. 12,988 the CPSC states the 
preemptive effect of this proposed regulation as follows.
    The PPPA provides that, generally, when a special packaging 
standard issued under the PPPA is in effect, ``no State or political 
subdivision thereof shall have any authority either to establish or 
continue in effect, with respect to such household substance, any 
standard for special packaging (and any exemption therefrom and 
requirement related thereto) which is not identical to the [PPPA] 
standard.'' 15 U.S.C. 1476(a). A State or local standard may be 
excepted from this preemptive effect if (1) the State or local standard 
provides a higher degree of protection from the risk of injury or 
illness than the PPPA standard; and (2) the State or political 
subdivision applies to the Commission for an exemption from the PPPA's 
preemption clause and the Commission grants the exemption through 
procedures specified at 16 CFR part 1061. 15 U.S.C. 1476(c)(1). In 
addition, the Federal government, or a State or local government, may 
establish and continue in effect a non-identical special packaging 
requirement that provides a higher degree of protection than the PPPA 
requirement for a household substance for the Federal, State or local 
government's own use. 15 U.S.C. 1476(b).
    Thus, with the exceptions noted above, this rule preempts non-
identical state or local special packaging standards for such drug 
products.

List of Subjects in 16 CFR Part 1700

    Consumer protection, Drugs, Infants and children, Packaging and 
containers, Poison prevention, Toxic substances, Reporting and 
recordkeeping requirements.

    For the reasons set forth above, the Commission amends 16 CFR part 
1700 as follows:

PART 1700--POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS

    1. The authority citation for part 1700 continues to read as 
follows:

    Authority: 15 U.S.C. 1471-76. Secs. 1700.1 and 1700.14 also 
issued under 15 U.S.C. 2079(a).

    2. Section 1700.14 is amended by republishing paragraph (a) 
introductory text and by adding new paragraph (a)(30) to read as 
follows:


Sec. 1700.14  Substances requiring special packaging.

    (a) Substances. The Commission has determined that the degree or 
nature of the hazard to children in the availability of the following 
substances, by reason of their packaging, is such that special 
packaging meeting the requirements of Sec. 1700.20(a) is required to 
protect children from serious personal injury or serious illness 
resulting from handling, using, or ingesting such substances, and the 
special packaging herein required is technically feasible, practicable, 
and appropriate for these substances:
* * * * *
    (30) Over-the-Counter Drug Products. (i) Any over-the-counter drug 
product in a dosage form intended for oral administration that contains 
an active ingredient also contained in a drug product that is or was a 
prescription drug product required by paragraph (a)(10) to be in 
special packaging shall be packaged in accordance with the provisions 
of Sec. 1700.15(a),(b), and (c). This requirement applies whether or 
not the amount of the active ingredient in the over-the-counter drug 
product is different from the amount of that active ingredient in the 
prescription drug product. This requirement does not apply to a drug 
product for which an application for over-the-counter marketing has 
been submitted to the FDA before January 29, 2002 or which has been 
granted over-the-counter status by the FDA before January 29, 2002. 
Notwithstanding the foregoing, any special packaging requirement under 
this section 1700.14 otherwise applicable to an over-the-counter drug 
product remains in effect.
    (ii) For purposes of this paragraph (30), active ingredient means 
any component that is intended to furnish pharmacological activity or 
other direct effect in the diagnosis, cure, mitigation, treatment, or 
prevention of disease or to affect the structure or any function of the 
body of humans; and drug product means a finished dosage form, for 
example, tablet, capsule, or solution, that contains a drug substance 
(active ingredient), generally, but not necessarily, in association 
with one or more other ingredients. (These terms are intended to have 
the meanings assigned to them in the regulations of the Food and Drug 
Administration appearing at 21 CFR 201.66 (2001) and 21 CFR 314.3 
(2000), respectively.)

    3. Section 1702.16 is amended by removing paragraph (b) thereof in 
its entirety.


[[Page 40116]]


    Dated: July 27, 2001.
Todd A. Stevenson,
Acting Secretary, Consumer Product Safety Commission.

List of Relevant Documents

    1. Briefing memorandum from Suzanne Barone, Ph.D., EH, to the 
Commission, ``Final Rule to Require Special Packaging for Oral 
Prescription Drugs that are Granted Over-the-Counter Status by the 
Food and Drug Administration,'' July 2, 2001.
    2. Letter from Debra L. Bowen, M.D., Acting Director, Division 
of Over-the-Counter Drug Products, Food and Drug Administration, to 
Jeffrey S. Bromme, Esq., General Counsel, Consumer Product Safety 
Commission, October 7, 1998.
    3. Memorandum from Robert L. Franklin, EC, to Suzanne Barone, 
Ph.D., EH, ``Economic Considerations Related to the Rule to Maintain 
Child-Resistant Packaging Requirements for Oral Prescription Drugs 
that Have Been Granted OTC Status by the FDA,'' May 31, 2001.
    4. Memorandum from Suzanne Barone, Ph.D., Project manager for 
Poison prevention, Directorate for health Sciences, to Sadye E. 
Dunn, Secretary, Consumer Product Safety Commission, ``Responses to 
Questions from Commissioner Moore on Over-the-Counter Switches,'' 
June 23, 2000.

[FR Doc. 01-19225 Filed 8-1-01; 8:45 am]
BILLING CODE 6355-01-P