CPG Sec. 640.100 Anthelmintics
Since no single active ingredient is effective to remove all species of worms in animals, *CVM* has advised manufacturers of animal wormers that they may represent their products for use only for the particular species of worm for which they are effective. *CVM* has further advised that not only should the labeling of anthelmintic products bear the common name followed by the scientific name of each worm species for which intended, but they may not be represented as a "worm expeller" or"vermifuge" since such terminology may represent a broad worm removal capability beyond that which the product possesses. *Anthelmintics marketed over-the-counter must also bear the label statement "Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism," as required by 21 CFR 500.25(b).* *Additionally, if the product is not generally recognized as safe and effective for its labeled uses, it may not be marketed unless it is covered by an approved new animal drug application.*
Anthelmintic preparations which are represented broadly as a vermifuge or a worm expellant and are not species specific in their labeling are violative. *CVM* will also consider safety and efficacy aspects of the products generally to determine their new animal drug status and may initiate appropriate action.
*REGULATORY ACTION GUIDANCE:
New animal drug charges may be recommended against such products where the labeling and formulation lack general recognition of safety and effectiveness.
Regulatory action based on a misbranding charge under 502(f)(1) will be considered when anthelmintics are not labeled with the common name, followed by the scientific name of each worm species, or the label bears such terms as "worm expeller" or vermifuge."*
*Material between asterisks is new or revised*
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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