Type of Posting: General Announcement
Posting Date: January 27, 2023
Expert Committees: Various
In accordance with the Rules and Procedures of the Council of Experts, this General Announcement is to provide notice that the responsible Expert Committees intend to modify the glass classifications in General Chapter <660> and to create additional flexibility for packaging and storage requirements in specified monographs, consistent with a request documented in a letter from the U.S. Food and Drug Administration.
Over the past several years, there have been reported shortages of glass vials. Products such as the COVID-19 vaccines and other parenteral products are packaged for delivery and administration in glass vials. Shortages of these vials could threaten the availability of these and other important products.
In response to supply chain challenges for certain glass vials, drug product manufacturers could propose to FDA the use of new packaging compositions that are suitable for their intended use with specified drug products. Under the Federal Food, Drug, and Cosmetic Act, drugs with a name recognized in the United States Pharmacopeia–National Formulary (USP–NF) must meet compendial standards for packaging and labeling unless certain administrative steps are taken to modify the requirement. (See Federal Food, Drug, and Cosmetic Act section 502(g)). A number of official monographs in the USP-NF require the use of a specific glass type, for example “Type I glass” or “Type II glass.” Current General Chapter <660> Containers – Glass defines glass types by composition-based characteristics, e.g., “Type I glass” is defined as borosilicate glass. Thus, manufacturers submitting a drug application to FDA for a drug product for which a USP-NF monograph with specific packaging requirements exists, could face regulatory hurdles if the product uses a new or different packaging composition from what is specified in the relevant monograph.
To address challenges, the proposed compendial revisions described in this General Announcement would include the following:
- Revisions to General Chapter <660> to remove glass classifications based on composition. Currently, <660> defines: Type I (borosilicate glass); Type II (treated soda-lime silica); and Type III (soda-lime silica). Under the proposal, General Chapter <660> would instead define glass Types I, II, and III by performance characteristics, allowing for additional compositions to be considered Type I, II, and III glass. There are no proposed changes to test procedures or acceptance criteria. Please see the Notice of Intent to Revise for additional details, background, proposed timeframes, and contact information.
- Revisions to 14 monographs that currently prescribe a specific glass type by adding the word “preferably” in the packaging section of the monograph –For example, a current monograph that requires “Type I glass” would be revised to state “preferably of Type I glass.” The addition of the word “preferably” to the monographs at issue means that the use of the glass specified is preferred, but not required. This proposed revision will give manufacturers additional flexibility in their choice of packaging and pave the way for new or different types of packaging to be approved. Please see the Notice of Intent to Revise for additional details, background, proposed timeframes, and contact information.