2023, the United States Pharmacopeia (USP) announced the introduction of a bill to amend < 660 > The glass classification in the chapter was changed from composition-based definitions to definitions based on performance characteristics, and more flexibility in packaging and storage requirements was created in the specific topic specification. The
current USP classification
notice for glass is as follows
: In accordance with the Committee's rules and procedures, this notice is intended to provide advance notice to the responsible expert committee of its intention to revise the definition of glass type in Section 660. And create more flexibility in packaging and storage requirements in specific subject matter instructions in response to letters from the FDA.
In the past few years, there have been reports of shortages of glass bottles. The packaging and dispensing of vaccines and other injectable products for COVID-19 is usually carried out in glass bottles. A shortage of glass bottles may affect the availability of these important products.
To address the supply chain challenges of certain glass vials, drug manufacturers may propose to the FDA use of a new package composition to accommodate their designated drug product. Under the Federal Food, Drug, and Cosmetic Act, in the United States Pharmacopeia-National Formulary, drugs bearing the name identified in the United States Pharmacopeia-National Formulary must meet the pharmacopeial standards for packaging and labeling unless certain administrative steps are taken to modify the requirements. (See section 502 (G) of the Federal Food, Drug, and Cosmetic Act). In the USP-National Formulary, there are a number of official subject matter instructions that require the use of specific glass types, such as "Class I glass" or "Class II glass.". In the current Chapter 660, glass types are defined based on compositional characteristics, for example, "Class I glass" is defined as borosilicate glass. Therefore, if a drug manufacturer submits a drug application that is different from a similar monograph in a Federal Pharmacopoeia-National Formulary with specific packaging requirements, it may face regulatory barriers.
To address these challenges, the pharmacopoeia revisions proposed in this circular include the following:
- Changes to chapter < 660 > to remove the classification of glasses based on their chemical composition. Currently, < 660 > Definition: & nbsp; I Type II (treated soda-lime glass); Type III (soda-lime glass). Under this proposal, Section 660 will define glass types I, II, and III by performance characteristics, allowing other compositions to be considered as glass types I, II, and III. Test procedures or acceptance criteria are not modified. See the Notice of Intent to Revise for more details, background, proposal schedule, and contact information.
- Amend 14 specialty sheets to remove current requirements that specify specific glass types by adding the word "preferably" to the packaging section of the sheet-for example, a specialty sheet that currently requires the use of "Class I glass" would be amended to read "Class I glass is preferred.". The addition of the word "best" to the relevant specialist instruction sheet means that the use of the specified glass is preferred but not required. This revised proposal will give manufacturers more flexibility in their choice of packaging and pave the way for new or different types of packaging to be approved. See the Notice of Intent to Revise for more details, background, proposal schedule, and contact information.
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