FDA Provides Recommendations on Injectable Drug Dose Labeling

October 22, 2015

On October 21, 2015, FDA released a draft guidance entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.” In this document, FDA provides recommendations on the labeling of injectable drugs based on their appropriate dose. Additionally, the Agency revised its definitions for single-dose and multiple-dose containers, and introduced “the definition of a new package type term, ‘single-patient-use’ container.”

New & Revised Definitions

Single-Dose Container: “a container of a sterile medication for parenteral administration (injection or infusion) that is not required to meet the antimicrobial effectiveness testing requirements.”

  • These containers are designed for one-time use by a single patient and should be labeled as such. The label of these products should also include appropriate discard statements. Vials, ampules, and prefilled syringes are all examples of single-dose containers.

Multiple-Dose Container: “a container of a sterile medication for parenteral administration (injection or infusion) that has met antimicrobial effectiveness testing requirements, or is excluded from such testing requirements by FDA regulation.”

  • These containers include more than one dose of the specified drug product, and are designed for more than one use. When space permits, the product should include the appropriate package type terminology. FDA also states that the “beyond-use-date” (the date or time beyond which a product should not be used) for a multiple-use container is assumed to be 28 days after the product is opened or entered (e.g., needle-punctured), unless otherwise stated by the manufacturer on the label. (Example: vial)

Single-Patient-Use Container: “a container of a sterile medication for parenteral administration (injection or infusion) that is intended to be used multiple times for a single patient. When space permits, a single-patient-use container is labeled as such and should include on the label appropriate discard statements. Examples of single-patient-use containers are patient controlled analgesia cartridges and certain pens for injection.”

  • In the past, FDA used the term “single-use” to refer to containers that are comprised of multiple doses, but intended for use by a single patient. However, the term, which was “inappropriately used as if it were interchangeable with the term ‘single-dose,’” has recently been retired and changed to “single-patient-use.”

Labeling Recommendations & Requirements

In addition to providing the definitions listed above, FDA also listed various recommendations and requirements for the labeling of injectable medical products. According to the guidance, “applicants should determine the proper package type term (‘single-dose,’ ‘multiple-dose,’ or ‘single-patient-use’) for injectable medical products for human use.” In order to allow users to easily identify the package type, the Agency also states that applicants should provide the appropriate package type term on all components of the product’s label, which includes the container label, carton label, and prescribing information (where applicable).

The guidance states that the term “single-dose” should be included on the labels of all single-dose products that have a United States Pharmacopeia (USP) monograph. FDA has found that there is sufficient space to include the information on the carton labeling. When space permits, containers for multiple-dose, single-patient-use, and single-dose products that do not have a USP monograph, should also include the appropriate package type term on the container label. However, “if there is insufficient space to include this information on the container label, the package type term should appear on the carton labeling where it will be easily visible.”

The discard statement should be included on the prescribing information for single-dose and single-patient-use injectable medical products, as well as on the carton (when there is space). The guidance provides an example of discard statement for single-use products, which is: “Discard unused portion.”

Because of the beyond-use-date, multiple-dose containers do not typically have a discard statement. However, if the beyond-use-date is different than the assumed 28 days, a discard statement should be included on the container and carton labeling and in the prescribing information. Examples of discard statements for multiple-dose containers include:

  • “Discard within XX hours after opening or after assembly”
  • “After first use, refrigerate or keep at a temperature not greater than XX for XX days.”

According to the draft guidance, FDA is recommending that necessary labeling changes are made within two years of the publication of the final guidance. The Agency also states that “all submissions (annual reports and supplements) should clearly identify the change(s) being made. In addition, a supplement submission to follow the recommendations in the guidance should be identified as ‘Labeling Changes to Follow the Package Type Term Guidance.’”

The guidance also provides recommendations for approved applicants submitting labelling changes (in accordance with the guidance), which can be found in the draft guidance here.

We can help ensure that your products are compliant with all labeling requirements. Using our proprietary approach, we have a proven track record of helping our clients achieve successful interactions & compliance with FDA. For more information about how we can help you, please contact us.


November 4, 2015

Progesterone Draft Guidance: Recommended Studies to Document Bioequivalence

On Friday, October 30, 2015, FDA released a draft guidance, entitled “Bioequivalence Recommendations for Progesterone,” in which the Agency offers product specific guidance on the design of...

FDA Warns Drug Manufacturers of Recalls due to BCC Contamination

On Monday, May 22nd, the FDA issued a warning for drug manufacturers regarding the contamination risk posed by Burkholderia cepacia complex (BCC). According to FDA’s warning, “BCC and other...

October 27, 2015

House Committee Releases Draft Discussion Bill Regarding FDA's Regulations of In Vitro Clinical Testing

On Tuesday, November 17, 2015, the House of Representatives’ Energy & Commerce Committee will hold a hearing entitled, “Examining the Regulation of Diagnostic Tests and Laboratory Operations.” The...