An investigational new drug is defined by the Code of Federal Regulations (CFR) as any new drug, vaccine, or other biological product for which FDA approval is being sought. Unlike FDA-approved substances that are commercially available, the labeling, packaging, and nomenclature of investigational products are not yet held to clear and strict regulatory guidance by the FDA. This gap in precise guidance can expose clinical testing sites to troubling product-related safety risks and participants' rights violations. Investigational drug labeling plays a crucial role in protecting participants during clinical trials, preventing misidentification, misuse, or other disruptions during the trial.
Under the FDA’s 21 CFR Part 312 guidelines, investigational drugs and biological products are subject to specific requirements for labeling. These are less standardized than those for commercial labeling, but are still regulated. The standards call for clear identification, traceability, and safety information.
While the CFR has issued recommendations for clinical trial safety labeling and packaging of investigational pharmaceuticals, many of these investigational product labeling guidelines focus on the behaviors of the clinical sites, thus placing the onus for error prevention heavily on the practitioners as opposed to the drug sponsors. For example, some of these recommendations include guidelines related to the handling of investigational controlled substances, informed consent, investigational drug applications, and institutional review board involvement.
The American Society of Health-System Pharmacists (ASHP) and the Hematology/Oncology Pharmacy Association (HOPA) have also released their own best practices regarding labeling for investigational drugs. These include guidance for clinical sites to establish dispensing and storage requirements for these investigational drugs as well as guidelines for tracking expiration dates and scanning barcodes.
The Joint Commission’s (TJC) Medication Management Standards also obligate accredited hospitals to manage, monitor, and supervise the use of any investigational drugs, and the standards require pharmacies to carefully maintain the storage and distribution of these investigational products.
However, as previously stated, these recommendations and requirements were developed to guide the protocols of clinical sites, medical practitioners, and pharmaceutical distributors. Regulations aimed towards investigational pharmaceutical sponsors are under less scrutiny when it comes to the labeling and packaging of these drugs.
The ISMP recommends that sponsors select a standard identifier for the investigational drug that is clearly distinctive from any other drugs undergoing clinical trials. The generic drug name should be determined early on in the process, ideally prior to the start of Phase II trials. If possible, it is critical to list both the generic name and the identifier on all materials, especially on the pharmaceutical labels.
Other best practices include:
Required Information on Clinical Trial Labels
The product's immediate container should include pharmaceutical labeling with the following elements:
Below, you will find an example of an investigational drug label:
Clinical Trial 87654321
XYZulumab (XYZ-789)
500 mg/50 mL (10 mg/ML)
Solution for IV infusion
Batch/Lot Number: _____
Expiration/Retest Date: _____
Medication Number: _____ (required for blinded studies)
Store at 2-8 °C, Protect from Light, Keep Vial in Outer Carton
Caution: New Drug—Limited by Federal (or United States) law to investigational use
Sponsor: Name and Address
The ISMP's pharmaceutical labeling requirements state that product label text should be printed in a font size of at least eight and the drug name should be in a larger, bold font. Tall man lettering (TML) is recommended to distinguish between similar drug names. A term coined by the ISMP, TML capitalizes dissimilar letters, starting on the left side of a drug name.
The ISMP recommends labeling the investigational product's outer carton with the following:
As expiration dates are extended, relabeling is essential; sponsors should update the pharmaceutical labeling prior to distribution.
U.S. vs. Global Clinical Trial Packaging Requirements
How Labeling Impacts Clinical Trial Success
Ensure Your Clinical Trial Labels Meet Requirements
Ultimately, investigational products and drugs should be packaged in a manner that prevents contamination and deterioration during transport and storage. While the labeling regulations are not as stringent for drugs in clinical trials and awaiting FDA approval, investigational pharmaceutical labeling should comply with appropriate requirements. The ISMP labeling guidelines listed above are designed to help drug sponsors preserve the integrity of their investigative drug trials as well as protect clinical trial participants' health, safety, and rights.
Working with PLPS means working with experts in regulated labeling for clinical trials and more. We have the expertise and processes to ensure accuracy, traceability, and drug labeling compliance to help reduce risks before trial execution.
To learn more about our support for drug and medical device labeling, reach out and speak with one of our team members today.
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