[Federal Register Volume 66, Number 246 (Friday, December 21, 2001)]
[Rules and Regulations]
[Pages 65836-65838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31400]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Child-Resistant Packaging for Certain Over-the-Counter Drug 
Products; Correction

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule; correction.

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SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) 
corrects the rule published in the Federal Register of August 2, 2001 
that requires child-resistant (CR) packaging of certain previously 
prescription-only oral drug products approved by the Food and Drug 
Administration (FDA) for over-the-counter (OTC) sale. Drug products 
that are the subject of the August 2 rule are members of the category 
known as ``OTC switched drug products.''
    The Commission intended that the August 2 rule apply to an oral 
drug product that is granted OTC status as

[[Page 65837]]

the result of an application to switch the product from prescription to 
OTC status (an OTC switch application) submitted to the FDA on or after 
the January 29, 2002 effective date of the CPSC rule, except in the 
following circumstances. The rule was not intended to cover a drug 
product that contains only active ingredients covered by prior OTC 
switch applications submitted by the same or any other applicant before 
the effective date of the CPSC rule. Since publication of the August 2 
rule, the Commission has become aware that a correction is necessary to 
avoid confusion over this point and is thus issuing a clarifying 
amendment.

DATES: Effective on January 29, 2002.

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. The Technical Correction

    The Commission published, in the Federal Register of August 2, 
2001, a regulation to require CR packaging of oral drug products 
approved by the FDA for OTC sale that contain active ingredients 
previously available only by prescription. 66 FR 40111. The regulation 
as proposed and as issued in final form was intended to apply only to 
an OTC drug product containing one or more previously prescription-only 
active ingredients first granted OTC status as a result of applications 
submitted to the FDA on or after the January 29, 2002 effective date of 
the final OTC-switch rule.
    Nevertheless, the August 2, 2001 rule can be read to require CR 
packaging of a drug product approved for the switch to OTC status after 
the rule becomes effective on January 29, 2002, even if that drug 
product contains only an active ingredient or ingredients for which 
application(s) for OTC switch were submitted to the FDA by any 
manufacturer(s) prior to the effective date. The CR packaging 
requirement of the rule could also be interpreted to be triggered by 
non-prescription active ingredients in previously prescription-only 
drug products. This was not the intent of the rule.
    The following examples are intended to clarify the scope of the 
rule as corrected today:

    Example 1: Manufacturer A submitted an application to the FDA in 
December 2001 for OTC switch of an oral drug product containing only 
prescription-only active ingredient X. Manufacturer A's application 
is approved by the FDA after the January 29, 2002 effective date of 
this rule. Manufacturer B submits an application to the FDA in 
February 2002 for OTC switch of another oral drug product containing 
only the same active ingredient X.
    Neither drug product is subject to this rule. Manufacturer A's 
drug product is not subject to this rule because the OTC switch 
application was submitted before the January 29, 2002 effective 
date. Manufacturer B's drug product is not subject to this rule 
because it contains only formerly prescription-only active 
ingredients for which an OTC switch application was submitted to the 
FDA by some manufacturer before the effective date of the rule.\1\

    \1\ Of course the situation where the OTC switch application has 
been submitted to the FDA and also approved prior to the effective 
date of the CPSC rule is covered by this example.
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    Example 2: Manufacturer A submits an application to the FDA in 
February 2002 for OTC switch of an oral drug product containing 
prescription-only oral active ingredient X. Active ingredient X is 
not the subject of an OTC switch application submitted by any 
manufacturer prior to the January 29, 2002 effective date of this 
rule.

    Manufacturer A's drug product must be in CR packaging under this 
rule because no application for OTC switch of prescription-only 
active ingredient X was submitted to the FDA by any manufacturer 
prior to the January 29, 2002 effective date of the rule.
    Example 3: Manufacturer A obtained FDA approval in December 2001 
for OTC switch of an oral drug product containing formerly 
prescription-only active ingredient X. Manufacturer B submits an 
application to the FDA in February 2002 for OTC switch of an oral 
drug product containing active ingredient X and prescription-only 
active ingredient Y. Active ingredient Y is not the subject of any 
OTC switch application submitted by any manufacturer prior to the 
effective date of this rule.
    Manufacturer A's drug product is not subject to this rule. 
Manufacturer B's drug product must be in CR packaging under this 
rule because no OTC switch application for prescription-only active 
ingredient Y was submitted to the FDA by any manufacturer prior to 
the January 29, 2002 effective date of the rule.

    Each of these examples pertains only to the scope of this rule. Any 
other special packaging requirements of 16 CRF 1700.14 otherwise 
applicable to a drug product remain in full force and effect.

B. The Administrative Procedure Act (APA)

    Section 553(b)(3)(B) of the APA authorizes an agency to dispense 
with certain notice procedures for a rule when it finds ``good cause'' 
to do so. 5 U.S.C. 553(b)(3)(B). Specifically, under section 
553(b)(3)(B), the requirement for notice and an opportunity to comment 
does not apply when the agency, for good cause, finds that those 
procedures are ``impracticable, unnecessary, or contrary to the public 
interest.'' This amendment does not alter the intended scope of the 
August 2, 2001 rule or otherwise widen its applicability. Accordingly, 
the Commission hereby finds that notice of, and public comment on, this 
technical amendment are unnecessary.

C. Other Rulemaking Requirements

    Because this amendment makes no change in the intended scope or 
applicability of the August 2, 2001 rule, the Commission hereby 
incorporates by reference the findings made with respect to it 
concerning the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., the 
National Environmental Policy Act, 42 U.S.C.4321, et seq., and 
Executive Order No. 12988. See 66 FR 40114-5 (August 2, 2001).
    For the foregoing reasons, the Commission corrects rule FR Doc. 01-
19225 published in the Federal Register on August 2, 2001, (66 FR 
40111) by making the following correcting amendment. On page 40115, in 
the third column, revise paragraph (a)(30)(i) in Sec. 1700.14 to read 
as follows:


Sec. 1700.14  Substances requiring special packaging.

    (a) * * *
* * * * *
    (30) Over-the-Counter Drug Products. (i) Any over-the-counter (OTC) 
drug product in a dosage form intended for oral administration that 
contains any active ingredient that was previously available for oral 
administration only by prescription, and thus was 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 that active ingredient 
in the OTC drug product is different from the amount of that active 
ingredient in the prescription drug product. This requirement does not 
apply if the OTC drug product contains only active ingredients of any 
oral drug product or products approved for OTC marketing based on an 
application for OTC marketing submitted to the Food and Drug 
Administration (FDA) by any entity before January 29, 2002. 
Notwithstanding the foregoing, any special packaging requirement under 
this Sec. 1700.14 otherwise applicable to an OTC drug product remains 
in effect.
* * * * *


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    Dated: December 17, 2001.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 01-31400 Filed 12-20-01; 8:45 am]
BILLING CODE 6355-01-P