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###### Consumer Product Safety Commission

          - 16 CFR Part 1700 

# AGENCY:

Consumer Product Safety Commission. 

# ACTION:

Final rule; correction. 

# 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                               ( print 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] 

# 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 § 1700.14 to read as follows:                 

§ 1700.14 

(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 § 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 § 1700.14 otherwise applicable to an OTC drug product remains in effect.                     

* * * * *

      ( print page 65838)    
Dated: December 17, 2001. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety Commission. 

# Footnotes

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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[FR Doc. 01-31400 Filed 12-20-01; 8:45 am] 

BILLING CODE 6355-01-P