Do repackaged OTC vitamins/supplements have to be in childproof containers?

August 6, 2007

When repackaging OTC vitamins/supplements, do they have to be in a childproof container?


Dietary supplements that contain the equivalent of 250 mg or more of elemental iron, from all sources, in a single container must be packaged in child resistant packaging (CRP), per Title 16 of the Code of Federal Regulations (CFR) 1700.14(a)(13). There are a variety of over-the-counter (OTC) drug products that require CRP (see 16 CFR 1700.14(a)). The regulations can be found here. In addition, product liability consideration may call for the use of CRP depending on the supplement involved and its toxicity profile. We recommend that you consult with a qualified attorney to determine the requirements or recommendations that apply to your specific product.