Numerous veterinary injectable drugs not the subject of approved NADAs are packaged in plastic containers, particularly large volume injectables. Under 21 CFR 211.94, the manufacturer must have supporting analytical data and written SOPs for the use of the container/closure system for each injectable product. At the present time *CVM* does not have available the kinds of suitability data on specific products in its file that would allow us to recognize the general safety of certain plastic containers for entire classes of animal drug products. Until those data are available, *CVM* will make decisions on a case by case basis.
*CVM* will provide comment and guidance regarding these products if the following information is submitted:
- the chemical/physical information that specifically characterizes the plastic container and closure in question,
- available data or reference to data that is used to demonstrate that the plastic container and closure are not reactive, additive or absorptive so as to alter the safety, identity, strength, quality, and purity of the drug beyond the established requirements
- available data or reference to data that is used to demonstrate that the container closure system (including the plastic container) provides adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination (including bacterial) of the drug product, and
- reference to any former advisory opinion of the Agency rendered on similar products using the same container and closure system, including opinions by *FDA's Center for Drug Evaluation and Research and/or Center for Biologics Evaluation and Research*.
Injectable animal drug products packaged in plastic containers not in accord with 21 CFR 211.94 may be deemed adulterated under sections 501(a)(2)(B), and/or 501(a)(3), and/or 501(a)(5) of the Act depending upon the adequacy of the supporting data.
*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)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.