[Federal Register Volume 70, Number 122 (Monday, June 27, 2005)]
[Rules and Regulations]
[Page 36836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12673]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Poison Prevention Packaging; Notice of Lifing of Stay of 
Enforcement for Lidoderm[reg] Patch

AGENCY: Consumer Product Safety Commission.

ACTION: Lifting Stay of Enforcement.

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SUMMARY: This notice announces the Commission's decision to lift a stay 
enforcement of special packaging requirements for the drug 
Lidoderm[reg]. The Commission issued the stay in August of 2001. The 
manufacturer of Lidoderm[reg] is now using packaging that complies with 
special packaging requirements.

DATES: The action will be effective on June 27, 2005.

FOR FURTHER INFORMATION CONTACT: Geri Smith, Office of Compliance, 
Consumer Product Safety Commission, Washington, DC 20207; telephone 
(301) 504-7529.

SUPPLEMENTARY INFORMATION: In 1995, the Commission issued a regulation 
under the Poison Prevention Packaging Act (``PPPA'') requiring child 
resistant (``CR'') packaging for lidocaine products with more than 5 
milligrams (mg) of lidocaine in a single package. 16 CFR 1700.14 
(a)(23).
    Lidoderm[reg] is a single-use dermal patch that contains lidocaine. 
Lidoderm[reg] is prescribed to treat post-herpetic neuralgia (``PHN''), 
a rare, chronic condition that results from nerve injury caused by 
shingles. Each Lidoderm[reg] patch contains 700 mg lidocaine. Under the 
PPPA, if a product requires special packaging, the immediate container 
of the product must be CR. This means that for Lidoderm[reg] to comply 
with the PPPA, each patch must be packaged in an individual CR pouch, 
or multiple patches that are not packaged in individual CR pouches must 
be packaged together in a single resealable CR pouch without envelopes.
    On August 14, 2000, the manufacturer of Lidoderm[reg], Endo 
Pharmaceuticals Inc. (``Endo''), petitioned the Commission for a 
partial exemption for Lidoderm[reg] from special packaging requirements 
stating that ``it is not practicable to market each Lidoderm[reg] patch 
in a child-resistant envelope.'' At that time, Lidoderm[reg] was 
marketed in the form of five patches inside a non-CR resealable 
envelope. One non-CR carton of Lidoderm[reg] contained six envelopes 
(each envelope contained five patches) for a total of 30 patches per 
carton. Endo asserted that placing each patch in a CR envelope would be 
cost prohibitive and would force it to discontinue production of 
Lidoderm[reg].
    The Commission declined to issue the exemption that Endo requested 
because, as explained in the August 30, 2001 stay notice, under the 
PPPA, the expense of special packaging cannot be the basis for an 
exemption. 66 FR 45842. However, the Commission did agree to stay 
enforcement of the special packaging requirements for Lidoderm[reg] 
under certain conditions specified in the notice of the stay. Id.
    Endo has informed the Commission that it is now packaging 
Lidoderm[reg] patches in CR packaging in full compliance with the PPPA 
requirements (each single-use patch is packaged in an individual CR 
pouch). Because the stay of enforcement is no longer necessary, the 
Commission has decided to lift the stay. This means that Lidoderm[reg], 
like any other item requiring special packaging under the Commission's 
PPPA regulations, must comply with all PPPA special packaging 
requirements.

    Dated: June 22, 2005.
Todd Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 05-12673 Filed 6-24-05; 8:45 am]
BILLING CODE 6355-01-P