Consumer Product Safety Commission.
Lifting Stay of Enforcement.
This notice announces the Commission's decision to lift a stay enforcement of special packaging requirements for the drug Lidoderm®. The Commission issued the stay in August of 2001. The manufacturer of Lidoderm® is now using packaging that complies with special packaging requirements.
The action will be effective on June 27, 2005.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Geri Smith, Office of Compliance, Consumer Product Safety Commission, Washington, DC 20207; telephone (301) 504-7529.End Further Info End Preamble Start Supplemental 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® is a single-use dermal patch that contains lidocaine. Lidoderm® is prescribed to treat post-herpetic neuralgia (“PHN”), a rare, chronic condition that results from nerve injury caused by shingles. Each Lidoderm® 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® 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®, Endo Pharmaceuticals Inc. (“Endo”), petitioned the Commission for a partial exemption for Lidoderm® from special packaging requirements stating that “it is not practicable to market each Lidoderm® patch in a child-resistant envelope.” At that time, Lidoderm® was marketed in the form of five patches inside a non-CR resealable envelope. One non-CR carton of Lidoderm® 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®.
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® under certain conditions specified in the notice of the stay. Id.
Endo has informed the Commission that it is now packaging Lidoderm® 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®, like any other item requiring special packaging under the Commission's PPPA regulations, must comply with all PPPA special packaging requirements.Start Signature
Dated: June 22, 2005.
Secretary, Consumer Product Safety Commission.
[FR Doc. 05-12673 Filed 6-24-05; 8:45 am]
BILLING CODE 6355-01-P