Regulatory Requirements for Clinical Trials
When a clinical trial will involve the home-use of solid, oral dose medication or when trials will be conducted either entirely or partially in the U.S., the new, investigational drug and its comparator should be housed in packaging that incorporates an approved child-resistant feature – at least for the portion of the trial conducted in the U.S.. It is also important to consider if there are advantages to conducting the entire trial in the same packaging.
Regulations for Clinical Trials Conducted in the U.S.
The following regulations apply to clinical trials packaging for home use in the U.S.:
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Poison Prevention Packaging Act (.pdf)
A requirement set out in the 1970 Poison Prevention Packaging Act (CFR16 part 1700) passed in the U.S. requires that all commercial drug packs be child resistant. This document is from the Consumer Product Safety Commission (CPSC). -
Guidelines for Clinical Trials Packaging destined for home use in the U.S. in 2000 (.pdf)
These guidelines are from the CPSC. -
Standard Classification of Child-Resistant Packages (.pdf)
This regulation requires the use of at least one approved child safety feature as listed in the ASTM International document library.
Note: The level of child resistance required is not specified for clinical trials – only that an approved feature must be used. And the regulations only apply to solid oral dose medication.
Regulations for Clinical Trials Conducted Outside the U.S.
The following regulations apply to clinical trials packaging outside the U.S.:
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Position Statement on the Packaging of Oral Cytotoxic Medicines for Clinical Trials, July 2005 (.doc).
Learn more from this document by the British Oncology Pharmacy Association at the Clinical Trials Tool Kit website.
Note: Child safety features are not currently required for use in clinical trials outside of the U.S., although blister strip packaging of some drugs (such as cytotoxic agents) intended for oral use is recommended.
