Must Packaging Oral Products for Clinical Studies be Tamper Evident?

December 4, 2007

Are there any current requirements for tamper evident features on packages for oral solutions or for oral solids in clinical studies? Does the requirement differ if the study will be done at hospital/clinical study center or if the study will be done at home? The only document we can found concerning tamper evident is 21 CFR 211.132 but this is only valid for OTC products.


There is no general requirement for tamper-evident packaging (TEP) for drugs used in clinical studies. FDA's Investigational New Drug (IND) regulations provide that the IND must include "a brief general description of the manufacturing and packaging procedure as appropriate for the product." See 21 CFR 312.23(a)(7)(iv)(b). It is possible that there may be circumstances under which it would be "appropriate" to have TEP for a particularly delicate drug product, but this would be decided in cooperation with FDA. In most cases, since the supplies of drugs used in clinical studies must be carefully monitored and controlled, there is no particular need for TEP since there should be no opportunity for an outside party to attempt to sabotage the quality of the product.