[Federal Register Volume 65, Number 169 (Wednesday, August 30, 2000)]
[Proposed Rules]
[Pages 52678-52684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21937]



16 CFR Part 1700

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

AGENCY: Consumer Product Safety Commission.

[[Page 52679]]

ACTION: Notice of proposed rulemaking.


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.


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 
    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 

    \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 

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 

    \2\ The Uniform Resource Locator (URL) for the CHPA website is: 
    \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

    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 

    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
                                                                Year CR
                                                    Year OTC-  packaging
                 Active ingredient                   switched
Diphenhydramine HCL...............................       1982       1984
Diphenhydramine monocitrate.......................       1982       1985
Ibuprofen.........................................       1984       1992
Loperamide........................................       1988       1993
Naproxen sodium...................................       1994       1996
Ketoprofen........................................       1995       1997

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 
    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 
    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 
    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 

    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 

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 
    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.

    \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.

    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 

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 
    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; 
    d. The nature and use of the household substance. 15 U.S.C. 
    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 

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 

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 
    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 

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 

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 

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:


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

    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 

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]