[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