Type of Posting: Notice of Intent to Revise
Posting Date: 27-Jan-2023
Targeted Official Date: 01-Apr-2023, Revision Bulletins
Expert Committee: Various
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise the packaging and storage statements in several USP monographs for parenteral products which currently use language prescribing a specific type of glass.
USP has posted General Announcement outlining USP’s two-prong approach to help address concerns about the supply of glass and glass vials, potentially threatening the availability of some existing parenteral products. Please also see the Notice of Intent to Revise for the General Chapter <660> Container-Glass, posted here.
To ensure that USP monographs for parenteral products provide sufficient flexibility for selecting a suitable type of packaging, USP performed a review of the Packaging and Storage requirements in all USP monographs for parenteral drug products.
There are about 380 USP monographs for parenteral products, including monographs for compounded preparations and monographs for biological products that may or may not include the term “Injection” in the title. Currently, there are about 330 monographs that prescribe a specific type(s) of glass in the Packaging and storage section. (Several monographs do not prescribe a specific type of glass, for example, stating “preserve in glass containers” or “preserve in suitable glass containers.”)
Our review indicated that the majority of the roughly 330 monographs (317) provide a certain level of flexibility for the type of packaging, for example, by including a reference to a preferable type of glass for packaging, rather than prescribing a specific type of packaging material. Below are examples of such Packaging and Storage statements in USP monographs for parenteral products (with the term “preferably” underlined for clarity):
- Preserve in single-dose containers, preferably of Type I glass.
- Preserve in single-dose containers, preferably of Type I or Type II glass
- Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
- Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type II glass.
While the term “preferably” is not explicitly defined in General Notices, the plain language indicates existing flexibility for selecting a suitable type of packaging material for the specified parenteral products, and are consistent with FDA’s letter supporting the use of additional glass compositions if they are demonstrated as suitable for the drug product.
As a part of the review, USP also identified 14 monographs for parenteral products that use prescriptive language to specify the type(s) of glass that must be used, such as “containers of Type I glass.” The list of these monographs is provided here.
As an expedient approach to address the challenges posed by potential shortages of packaging materials, USP is proposing the addition of the word “preferably” to the Packaging and Storage statements in the monographs that currently use prescriptive language, to introduce additional flexibility for manufacturers and regulators. These changes will also create greater consistency in the Packaging and Storage requirements across USP monographs for parenteral drug products. In the long term, additional changes to a large number of monographs may be needed to fully address the paradigm shift in defining suitable packaging for parenteral products.
Considering the potential impact of glass production issues and any resulting global shortages, USP is planning to use the Accelerated Revision process to implement these changes.
Should you have any questions, please contact Elena Gonikberg, Sr. Principal Scientist (firstname.lastname@example.org).