Child-Resistant Packaging for Certain Over-The-Counter Drug
Products
[Federal Register: August 30, 2000 (Volume 65, Number 169)]
[Proposed Rules]
[Page 52678-52684]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au00-20]
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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.
[[Page 52679]]
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) is
proposing a rule to require child-resistant (CR) packaging on 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, at present, there is no general requirement for
CR packaging of such drug products in forms subsequently approved by
the FDA for OTC sale.
The Commission is also proposing to revoke 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 Office of the Secretary must receive comments on this
proposal on or before November 13, 2000.
ADDRESSES: Mail comments to the Office of the Secretary, Consumer
Product Safety Commission, Washington, D.C. 20207, or hand deliver them
to the Office of the Secretary, Consumer Product Safety Commission,
Room 502, 4330 East-West Highway, Bethesda, Maryland 20814-4408,
telephone (301) 504-0800. Comments may also be filed by telefacsimile
to (301) 504-0127 or by email to cpsc-os@cpsc.gov.
FOR FURTHER INFORMATION CONTACT: Suzanne Barone, Directorate for Health
Sciences, Consumer Product Safety Commission, Washington, D.C. 20207;
telephone (301) 504-0477 ext. 1196.
SUPPLEMENTARY INFORMATION:
A. Background
1. Current Approach to CR Packaging Requirements
The Poison Prevention Packaging Act, 15 U.S.C. 1471-1476, was
enacted to protect children from serious personal injury or illness
resulting from handling, using, or ingesting hazardous substances.
Under the PPPA the CPSC can require CR packaging of hazardous household
chemicals, including drug products. The CPSC regulations currently
require CR packaging of all oral prescription drug products that have
not been specifically exempted from that requirement. 16 CFR
1700.14(a)(10).
In contrast, OTC drug products, also referred to as nonprescription
drug products, are not now regulated as a class under the PPPA.
However, a number of specific OTC drug products have been required by
Commission regulation to have CR packaging. These drug products and the
effective dates of the CR requirements are: (1) Aspirin (1972), (2)
liquid methyl salicylate (1972), (3) iron-containing drug products
(1978), (4) acetaminophen (1980), (5) diphenhydramine (1984), (6)
ibuprofen (1992), (7) loperamide (1993), (8) lidocaine (1996), (9)
dibucaine (1996), (10) naproxen (1996), (11) ketoprofen (1997), and
(12) minoxidil (1999).
Diphenhydramine, ibuprofen, loperamide, naproxen, and ketoprofen
were active ingredients available originally only in oral dose
prescription drug products.\1\ Drug products containing them therefore
required CR packaging under the Commission's general oral prescription
drug product CR packaging regulation. The FDA subsequently approved
these active ingredients for use in OTC drug products at specific
dosage levels. The OTC forms were not subject to the Commission's CR
packaging requirement for oral prescription drug products. The CPSC
conducted a rulemaking and promulgated a separate regulation to require
CR packaging for OTC products containing each of these active
ingredients.
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\1\ The meanings of the terms active ingredient and drug product
as used in this rulemaking are the same as the meanings assigned to
those terms in the drug product regulations of the FDA. The FDA drug
product regulations define active ingredient as ``any component (of
a drug product) 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, but does not include
intermediates used in the synthesis of such ingredient.'' 21 CFR
201.66 (1999). The FDA regulations define drug product as ``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.'' 21 CFR 314.3 (1999). Drug product also encompasses a
product containing more than one active ingredient. 21 CFR 300.50
(1999).
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2. The Limited Effect of FDA Approval of an OTC-Switch
The FDA approves drug products containing a single active
ingredient or a combination of active ingredients for sale in the
United States. This includes approval for sale directly to the consumer
in OTC product formulations. The primary responsibility of the FDA with
respect to OTC drug products is to assure that they are safe and
effective when self-administered by a consumer in a proper manner. The
FDA does not base granting of OTC status on whether a drug product
would be toxic to a child if unintentionally ingested. The FDA
confirmed this in a letter to CPSC staff dated October 7, 1998 stating
that ``approval of an OTC switch does not in any way imply that FDA has
concluded that the product does not continue to need child-resistant
packaging.'' A copy of the FDA letter is available in the docket for
this rulemaking.
3. Frequency of OTC-Switches
Since 1976, the FDA has permitted many drug products to be sold
OTC. According to the Consumer Healthcare Products Association (CHPA)
website, ``more than 600 OTC products on the market today use
ingredients or dosages available only by prescription just 20 years
ago. ''\2\ Trade press articles speculate that this trend will
continue.\3\ The CHPA has compiled a table listing 80 drug products
that have been granted OTC status since 1976.\4\ Of the 80 listings in
the table, 22 are oral drug products that were previously available by
prescription. The other listings are topical drug products, new uses,
or new formulations for existing OTC drug products, or OTC-approved
drug products that were not previously available as prescription
products.
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\2\ The Uniform Resource Locator (URL) for the CHPA website is:
www.ndmainfo.org
\3\ Levy, S., Several Prescription Candidates Reported Ripe for
OTC Switching, Drug product Topics, November 16, 1998, p.51.
\4\ The CHPA Table is available on that organization's website
at: www.ndmainfo.org/pdfs/Switch%20List/pdf
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The FDA is currently evaluating whether other drug products or drug
product categories should be OTC-switched. That agency conducted a two-
day public hearing in late June of this year on a spectrum of OTC
issues, including OTC switches. In the April 27, 2000 Federal Register
notice announcing the hearing, 65 FR 24704-6, the FDA stated that it
had ``received comments suggesting that a number of other types of
drugs should be considered for OTC status.'' The FDA notice indicated
that the types of drug products suggested for OTC status include
diuretics, antihypertensive agents, cholesterol-lowering drug products,
antidiabetic drug products, treatments for osteoporosis, drug products
for stomach problems, etc.
4. OTC-Switched Drug Products Currently Subject to CR Packaging
Requirements
To date, the Commission has required CR packaging for OTC products
containing 6 of the 22 oral prescription active ingredients that have
also been approved for sale in OTC products. The six active ingredients
that currently
[[Page 52680]]
require CR packaging in OTC products, the date of OTC approval by the
FDA, and the effective date of the CR packaging requirements are listed
in Table 1. The other 16 active ingredients are discussed below.
Table 1: Prescription Active Ingredients Switched to OTC Status That
Require CR Packaging
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Year CR
Year OTC- packaging
Active ingredient switched
effective
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Diphenhydramine HCL............................... 1982 1984
Diphenhydramine monocitrate....................... 1982 1985
Ibuprofen......................................... 1984 1992
Loperamide........................................ 1988 1993
Naproxen sodium................................... 1994 1996
Ketoprofen........................................ 1995 1997
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5. History of CPSC Regulation of OTC-Switched Oral Drug Products
In the past, CPSC staff focused primarily on ingestion data to
recommend to the Commission what products should be in CR packaging. In
the late 1970s the FDA allowed the OTC sale of several antihistamines
that were previously available only by prescription. Of these,
diphenhydramine hydrochloride was the first OTC-switched active
ingredient regulated by the CPSC under PPPA authority. Then, in 1982,
the FDA approved the monocitrate salt of diphenhydramine for OTC sale.
The existing diphenhydramine hydrochloride CR packaging regulation was
then amended to cover all diphenhydramine salts.
In 1984, the CPSC staff evaluated ingestion data related to
ibuprofen. Products containing ibuprofen were granted OTC status during
that year. At that time, the poisoning data were limited and Commission
staff did not recommend CR packaging. The two companies that first
marketed OTC ibuprofen products used CR packaging voluntarily on some
package sizes.
In 1989, CPSC staff revisited ibuprofen toxicity because ibuprofen
had become widely available. Not all companies were using CR packaging
and serious injuries to children resulted. The Commission issued a rule
requiring CR packaging for all of these products. 16 CFR
1700.14(a)(20). Companies that had been marketing their products in
non-CR packaging changed their packaging accordingly.
The experience with diphenhydramine and ibuprofen resulted in a
change in the staff's approach to recommendations for CR packaging for
OTC-switched products. Rather than wait for deaths or injuries to
children, Commission staff has become more proactive in recommending CR
packaging requirements for OTC drug products. For the past several
years the staff has focused on the potential toxicity of active
ingredients contained in drug products that are going to be switched
instead of waiting for poisonings to occur after a product is released
and marketed for OTC sale. The staff has made the evaluation of
potential switched drug products the first priority. As a result,
separate regulations for products containing loperamide, naproxen, and
ketoprofen were promulgated by the Commission soon after OTC status for
products containing each of these active ingredients was granted by the
FDA.
CPSC staff monitors FDA's activities concerning approval of
switched OTC drug products. The staff attends FDA advisory panel
meetings when possible, to better understand any issues about a
potential switch and the likelihood of approval of OTC status by the
FDA. The FDA is not bound to accept the panel's recommendations
regarding OTC switches, though in most cases the FDA does. The review
of the potential toxicity to young children of the active ingredient or
ingredients in the product then becomes a priority for the CPSC staff.
To avoid expending the CPSC's limited resources if the FDA does not
approve OTC sale of the drug product, Commission staff waits for FDA
approval before proceeding with a review. The proposed rule would
eliminate this lag between FDA approval of an OTC-switch and the CPSC
requirement to maintain CR packaging.
The 16 oral prescription active ingredients that were switched to
OTC status and are not currently required to have CR packaging are
pseudoephedrine HCL, pseudoephedrine sulfate, phenylpropanolamine HCL,
clemastine fumarate, brompheniramine maleate, chlorpheniramine maleate,
dexbrompheniramine maleate, triprolidine HCL, dexchlorpheniramine
maleate, doxylamine succinate, pyrantel pamoate, chlophedianol HCL,
famotidine, cimetidine, ranitidine, and nizatidine. In conjunction with
this rulemaking, CPSC staff has preliminarily assessed the toxicity of
eight of these. Based on their toxicity, the staff would recommend CR
packaging for drug products containing pseudoephedrine HCL,
pseudoephedrine sulfate, phenylpropanolamine HCL, and clemastine
fumarate.
The four active ingredients for which the CPSC staff would not
recommend CR packaging are members of the same family of antihistamines
used to reduce stomach acid. These are famotidine, cimetidine,
ranitidine, and nizatidine. These substances do not have the degree of
toxicity associated with antihistamines used to treat cold symptoms.
Five antihistamine active ingredients that are currently under
preliminary review by Commission staff are brompheniramine maleate,
chlorpheniramine maleate, dexbrompheniramine maleate, triprolidine HCL,
and dexchlorpheniramine maleate. These antihistamines are related in
structure and activity to diphenhydramine, which is currently subject
to a CR packaging requirement.
This rulemaking proposal would not retrospectively require CR
packaging of FDA-approved drug products containing the 16 OTC-switched
active ingredients not currently subject to CR packaging requirements.
CPSC staff continues to evaluate these substances as time and other
priorities permit. Many drug products containing these active
ingredients are in CR packaging because they contain other active
ingredients that require CR packaging, for example pseudoephedrine with
ibuprofen or an antihistamine with acetaminophen or aspirin. In
addition, the Commission is aware of some OTC products that are
voluntarily marketed in CR packaging.
B. Relevant Statutory and Regulatory Provisions
The Poison Prevention Packaging Act 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.
Sec. 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 adults''
to use properly. 15 U.S.C. 1471(4). Household substances for which the
Commission may require CR
[[Page 52681]]
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 CR packages 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.
C. The Proposed Rule
1. General Approach
The Commission is proposing a rule to require that CR packaging
requirements applicable to any 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.
This rule will provide children with the same protection when a drug
product is more widely available as an OTC preparation that they had
when it was available only by prescription. The rule would eliminate
the possibility of a drug product being available in non-CR packaging
for an extended time before the CR packaging requirement is reimposed
by Commission rulemaking. The need to continue to protect children does
not diminish when an oral prescription drug product is granted OTC
status. As noted above, a decision by the FDA to grant OTC status for a
prescription drug product does not include a finding that there is a
lack of toxicity to a child if the drug product is accidentally
ingested in an unpredictable amount, which could be the entire contents
of the OTC product package. The active ingredient(s) in the drug
product still have the same toxicity, whether the drug product is in
prescription or OTC form.
2. Additional Uses, Forms, and Combinations of OTC-Switched Drug
Products
The FDA can approve a new usage or a new dosage form of a
previously-approved OTC-switched drug product. 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. For example, after
February 11, 1985, any oral product that contained more than the
equivalent of 66 mg. of diphenhydramine base was required to be in CR
packaging. At that time, diphenhydramine was in OTC sleep aids and hay
fever preparations. In 1987, when diphenhydramine was approved by the
FDA for OTC sale as an oral antiemetic drug product, no further CPSC
regulatory action was necessary. This same focus on the active
ingredient itself rather than the approved usage is the approach of the
proposed rule. If an oral prescription drug product were granted OTC
status by the FDA it would automatically be subject to a CR packaging
requirement under the proposed rule. If the FDA then approved another
OTC drug product containing some or all of the active ingredients in
that drug product, the new drug product would also automatically be
subject to the 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.
Formulations other than oral, such as topical preparations, or
transdermal patches would still be regulated individually and therefore
not affected by this proposed rule.
In some cases, after a prescription drug product is approved for
OTC sale by the FDA, other forms, dosages, or combinations containing
some or all of the active ingredients in that drug product will also be
approved for OTC sale. These combinations or forms may not have existed
when the drug was available by prescription only. This proposal would
cover these situations. For example, loperamide was granted OTC status
by the FDA in 1988. In 1993, the CPSC required CR packaging for any
oral product that contained more than 0.045 mg of loperamide. In 1997,
the FDA approved the combination of loperamide and simethicone in an
OTC product. This combination was never a prescription product.
However, the combination OTC product is subject to the CR packaging
requirement because the loperamide rule is not limited to the original
prescription formulation.
3. Change in Dosage Between Prescription and OTC Drugs
The prescription version of a drug product may be available in
different dosages, strengths, and forms. However, the FDA may place
restrictions on the allowed level of an active ingredient available for
use in an OTC drug product. Several different scenarios exist. First,
the active ingredient may be sold in an OTC drug product at the lowest
prescription dosage. This is true for many OTC-switched drug products,
including the antihistamines. Second, the active ingredient may be sold
OTC at the prescription strength but with a lower total daily allowable
dose. This is the case for OTC loperamide products. Lastly, a lower
dosage of the active ingredient may be developed for the OTC drug
product. OTC ibuprofen and naproxen are examples.
This proposal 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 is consistent with the approach of the CPSC's oral
prescription drug product CR packaging regulation, which applies to all
dosages approved by the FDA for prescription sale. This recognizes the
reality that absent CR packaging, the ``dose'' potentially available to
a child is the entire package contents.
The Commission has issued rules for individual OTC switched drug
products that are only available at a lower dose than the prescription
strength product. The Commission's experiences with ibuprofen and
naproxen demonstrate that toxic amounts of the active ingredients are
available from a single OTC product container even at these new lower
dosages.
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. Companies petition the Commission to exempt products
by submitting data, described in 16 CFR Part 1702, to support a
conclusion either that: (1) the drug product will not cause serious
injury or illness, or (2) it is not technically possible to develop and
produce CR packaging for the drug product. An exemption petition is
processed by informal, notice and comment rulemaking. Currently, 18
oral prescription drug products and several OTC formulations of
aspirin, acetaminophen, and iron have been exempted from the CR
packaging requirements. 16 CFR 1700.14. Under the proposed rule, this
exemption procedure would remain available to manufacturers of OTC-
switched products.
[[Page 52682]]
5. Timing of Exemption Petitions
The Commission's current CR packaging regulations specify that the
Commission shall deny an exemption petition if the FDA has not approved
the new drug product. 16 CFR 1702.16(b). Therefore,at present, a
company seeking an exemption for a newly approved drug product must
either market in CR packaging, delay marketing until the Commission
acts on the petition, or request a stay of enforcement to allow
marketing in non-CR packaging while the Commission considers the
petition.
A post-marketing change in packaging of an approved OTC drug
product may be more complex for the manufacturer than simply buying
different packaging and modifying the packaging equipment. In some
cases, the FDA must approve the new packaging before the drug product
can be marketed.\5\ Stability testing of the product in the new package
must be completed and the results approved by the FDA before the
product can be marketed in the new package.
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\5\ Guidance for Industry, Changes to An Approved NDA or ANDA.
Food and Drug Administration, Drug Information Branch, Center for
Drug Evaluation and Reserech, November 1999. This document is
available on the FDA website at: www.fda.gov/cder/guidance/index.htm
Copies can also be obtained by calling the FDA Drug Information
Branch at (301) 827-4573.
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Accordingly, the Commission is proposing to revoke 16 C.F.R.
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.
6. Listing of OTC-Switched Drug Products Subject to CR Packaging
To assist consumers and industry in identifying which OTC-switched
drug products require CR packaging, the Commission intends to maintain
a list of such drug products as an appendix to the regulations at 16
CFR 1700.14. As the FDA approves OTC-switches, the list would be
updated periodically by publishing a revised appendix in the Federal
Register.
D. Findings
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. 9,431.
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 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 CPSC 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.
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 notice, and preliminarily finds no
reason to conclude that the rule is unreasonable or otherwise
inappropriate.
E. Applicability
The packaging configuration for a drug product to be switched is
determined before a company submits the OTC-switch application to the
FDA. Accordingly, the Commission is proposing that this rule apply
prospectively to drug products for
[[Page 52683]]
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).
F. 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.
CR packaging is currently available commercially for most, if not
all, types of oral prescription drug products that would be subject to
this rulemaking. Thus, the Commission is proposing that the final rule
take effect 180 days after its publication.
G. 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 an 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 a
preliminary assessment of the impact of a rule to maintain CR packaging
for OTC-switched drug products. A copy of the preliminary analysis is
available for inspection in 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
also notes that the incremental cost may be somewhat higher if the
marketer provides more elaborate packaging in the effort to create
``shelf appeal'' to attract consumers and compete with other OTC
products in the same therapeutic category.
At present, the Commission does not have quantitative information
on the number of small businesses that might be affected by the OTC-
switch proposal. However, the staff assessment concludes that because
the incremental cost of CR packaging is minimal, and because these
costs (if any) are likely to be passed on to consumers, it is unlikely
that the proposal will have a substantial effect on a significant
number of small businesses. The Commission requests comment from
companies that supply OTC-switched drug products. The Commission is
particularly interested in information on the likely effect of this
proposed rule on small businesses.
Many OTC-switched drug products are already 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 notice proposes revocation of 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
the rule to maintain CR packaging for OTC-switched drug products, if
promulgated in final form as proposed, would not have a significant
impact on a substantial number of small businesses or other small
entities.
H. 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 proposed 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.
I. Executive Orders
As provided for in Executive Order 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, the proposed rule requiring
CR packaging for OTC-switched drug products would preempt non-identical
state or local special packaging standards for such drug products.
J. Trade Secret or Proprietary Information
Any person responding to this notice who believes that any
information submitted is trade secret or proprietary should
specifically identify the exact portions of the document claimed to be
confidential. The Commission's staff will receive and handle such
information confidentially and in accordance with section 6(a) of the
Consumer Product Safety Act (CPSA), 15 U.S.C. 2055(a). Such information
will not be placed in the public docket for the rulemaking and will not
be made available to the public simply upon request. If the Commission
receives a request for disclosure of the information or concludes that
its disclosure is necessary to discharge the Commission's
responsibilities, the Commission will inform the person who submitted
the information and provide that person an opportunity to present
additional information and views concerning the confidential nature of
the information. 16 CFR 1015.18(b) (1999).
[[Page 52684]]
The Commission's staff will then make a determination of whether
the information is trade secret or proprietary information that cannot
be released. That determination will be made in accordance with
applicable provisions of the CPSA; the Freedom of Information Act
(FOIA), 5 U.S.C. 552b; 18 U.S.C. 1905; the Commission's procedural
regulations at 16 CFR part 1015 governing protection and disclosure of
information under provisions of FOIA; and relevant judicial
interpretations. If the Commission concludes that any part of the
information that has been submitted with a claim that the information
is a trade secret or proprietary is disclosable, it will notify the
person submitting the material in writing and provide at least 10
calendar days from the receipt of the letter to allow for that person
to seek judicial relief. 15 U.S.C. 2055(a)(5) and (6); 16 CFR
1015.19(b).
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 proposes to amend
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)(32) 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:
* * * * *
(32) 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) of this section
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 [insert date 180 days
after promulgation of final rule] or which has been granted over-the-
counter status by the FDA before [insert date 180 days after
promulgation of final rule]. Notwithstanding the foregoing, any special
packaging requirement under this Sec. 1700.14 otherwise applicable to
an over-the-counter drug product remains in effect.
(ii) For purposes of this paragraph (a)(32), 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 and 21 CFR
314.3, respectively.)
Sec. 1702.16 [Amended]
3. Section 1702.16 is amended by removing paragraph (b) thereof in
its entirety.
Dated: August 23, 2000.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
List of Relevant Documents
1. Briefing memorandum from Suzanne Barone, Ph.D., EH, to the
Commission, ``Proposed Rule to Require Special Packaging for Oral
Prescription Drugs that are Granted Over-the-Counter Status by the
Food and Drug Administration,'' May 16, 2000.
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 Marcia P. Robins, EC, to Suzanne Barone,
Ph.D., EH, ``Economic considerations: Proposal to Maintain Child-
Resistant Packaging Requirements for Oral Prescription Drugs that
Have Been Granted OTC Status by the FDA,'' April 7, 2000.
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. 00-21937 Filed 8-29-00; 8:45 am]
BILLING CODE 6355-01-P