CVM has received several complaints about products labeled for oral, topical, or other routes of administration that are packaged in a manner customarily considered to be for parenteral administration. Among the products packaged in this manner are aloe vera products labeled for topical use in shurjet/squeeze jets (squeeze tubes with long tips that are routinely used for intramammary infusion); probiotic products labeled for oral use packaged in syringes with sterile diluent in plastic vials with udder infusion canulas and alcohol pads; and selenium vitamin E and other vitamin/mineral products labeled for oral use packaged in sterile vials closed with a metal ring and rubber injection stopper.
CVM is very concerned about the safety of products not approved for parenteral use which are infused or injected into food-producing animals. The health consequences associated with this practice are potentially serious for both the animal and humans consuming milk or meat from animals treated with these products. Oral products, particularly those labeled for food use, are not ordinarily prepared under the same stringent controls as those products intended for parenteral drug use. Also, the residue depletion curve for parenterals is likely to be altogether different than that for oral or topical use.
CVM believes that the packaging and labeling of these products is a subterfuge to avoid the more stringent regulatory requirements for parenteral drugs. It is not economically or scientifically rational for any oral or topical products to be packaged in sterile containers such as injection seal closure vials or with associated devices such as cannulas and injection syringes. The intended use of these products is for parenteral administration not withstanding the labeled directions and/or indications. These products are therefore drugs under ?201(g) of the Act and are subject to all the applicable requirements of the Act.
Products that are intended for oral or topical administration should not be packaged to facilitate parenteral administration. Products intended to be administered to food-producing animals, packaged in a manner that suggests parenteral administration, but labeled for oral, topical or other routes of administration, will be considered by FDA to be drugs intended for parenteral administration. If these products do not bear adequate directions for parenteral administration, they will be deemed misbranded within the meaning of 502(f)(1) and/or 502(i)(1).
REGULATORY ACTION GUIDANCE:
A warning letter should be recommended to HFV-236 for commercial animal products labeled for oral, topical, or other routes of administration, but packaged in a manner considered to be suitable for infusion or injection in food animals. If such products are packaged for non-food animal use, Case Guidance Branch (HFV-236) should be contacted for guidance.
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.