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Regulations For Clinical Trial Labeling

June 10, 2021

An investigational new drug is defined by the Code of Federal Regulations (CFR) as "a new drug or biological drug that is used in a clinical investigation." In other words, it is 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.

Safety Concerns Around Clinical Trial Labeling

  • Look-alike names during the early phases of research
  • Generic names chosen in later phases of research not added to the label
  • Unlabeled containers or outer packaging
  • Labels without a distinctive or discernable drug name
  • Inaccurate expiration dates or retest dates
  • Essential product information hidden underneath the peel-off label
  • Incorrect quantities listed on the label

While the CFR has issued recommendations for the safe labeling and packaging of investigational pharmaceuticals, many of these 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 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.

Currently, the CFR does require that the following warning be clearly printed on the pharmaceutical labeling of any investigational drug: “Caution: New Drug—Limited by Federal (or United States) law to investigational use.”

Pharmaceutical labels must also be free of false or misleading statements and cannot imply that the product is safe or effective.

Fortunately, the Institute for Safe Medication Practices (ISMP) offers more concrete and thorough error mitigation strategies for sponsors to take prior to clinical trials.

Error Prevention Strategies for Clinical Trial Labeling

To begin, 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. 

Before requesting approval for testing by the FDA, investigative drug sponsors should perform a thorough risk assessment on the product's name and pharmaceutical labeling in order to detect and correct any potential risks that could lead to dangerous medication errors. 

Immediate Container Labeling

The product's immediate container should include pharmaceutical labeling with the following elements:

  • Clinical trial number
  • Generic name followed by the standardized identifier in parentheses
  • Dosage, concentration, and strength
  • Formulation (whether it's a tablet, capsule, solution, etc.)
  • Quantity
  • Lot or batch number
  • Expiration date and retest date
    • If not printed on the pharmaceutical labeling, these must be present on the packing slips included in each shipment
  • Medication number (only if it is a blinded study)
  • Storage requirements
  • Name and address of the sponsor
  • The CFR statement
    • “Caution: New Drug—Limited by Federal (or United States) law to investigational use.”

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.

Outer Packaging Labeling

The ISMP recommends labeling the investigational product's outer carton with the following:

  • Product name
  • Dosage, strength, and concentration
  • Formulation
  • Protocol number
  • Quantity
  • Lot or batch number
  • Storage requirements
  • Barcode to identify the product when scanned

The primary label should be written in English for studies conducted in the United States, and labels provided in additional languages beneath the peel-off label should have a standardized format. Finally, as expiration dates are extended, relabeling is essential; sponsors should update the pharmaceutical labeling prior to distribution.

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's suggestions 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.

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