Question & Answer Regarding Regulatory Changes to: USP <87>, USP <88> Class VI, USP <665>, USP <381>, and USP <383>[i]
What is the USP? What do they govern?
United States Pharmacopeia (USP) is an independent, nonprofit organization that sets quality standards for medicines, dietary supplements, and some food ingredients used in the United States and many other countries.
USP governs or publishes standards for:
- Pharmaceutical ingredients (APIs)
- Finished drug products
- Dietary supplements
- Excipients (inactive ingredients)
- Compounded medications
- Packaging and storage requirements
- Testing methods for identity, potency, impurities, and contamination
What is the USP <87> prior to 12/1/2026?
USP <87> Biological Reactivity Tests (In Vitro)
USP <87> is used to evaluate whether a material causes cell toxicity (cytotoxicity) when it comes into contact with living cells. This test helps determine whether chemicals extracted from the material can damage cells.
USP <87> is commonly used for:
- Medical device materials
- Rubber compounds
- Elastomers
- Plastics
- Pharmaceutical packaging
- Tubing, gaskets, seals, and O-rings
What is the USP <88> Class VI prior to 12/1/2026?
USP <88> Class VI Biological Reactivity Tests (In Vivo)
USP <88> Class VI is a set of animal-based biological reactivity tests used to evaluate whether a material is safe for use in medical, pharmaceutical, or bioprocessing applications. In this test, a material is extracted under different conditions using various extraction solutions to simulate real use. The resulting extracts are then injected or implanted into animals to assess potential harmful effects.
USP <88> Class VI is commonly used for:
- Plastics
- Rubber and elastomers
- Gaskets, seals, tubing
- Medical device components
- Pharmaceutical processing materials
What is the USP <665> effective 5/1/2026?
USP <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products.
USP <665> provides a risk-based qualification approach for plastic manufacturing systems. It addresses whether these plastic materials can release chemicals (extractables/leachables) into the drug product during manufacturing.
USP <665> applies to both single-use systems (SUS) and multi-use systems (MUS), such as:
- Tubing
- Bags
- Filters
- Connectors
- Mixing systems
- Bioprocess containers
- Seals and gaskets
What is the USP <381> effective 12/1/2025?
USP <381> Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems.
USP <381> establishes requirements for elastomeric components used in injectable pharmaceutical packaging and delivery systems. It applies to elastomeric components made from both thermoset and thermoplastic elastomeric materials and is intended to address the protection, compatibility, safety, and performance of these components in their intended applications.
USP <381> evaluates elastomeric components through requirements including:
- Biological reactivity
- Physicochemical testing
- Extractable substances and related chemical characteristics
- Extractable elements
- Fragmentation testing
- Other applicable requirements for elastomeric components used in injectable pharmaceutical packaging and delivery systems
What is the USP <383> effective 12/1/2027?
USP <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components.
USP <383> was developed because traditional elastomer chapters like USP <381> mainly focused on injectable-package closures and did not adequately address modern silicone-based manufacturing components and single-use systems.
USP <383> evaluates cured silicone elastomers for:
- Physicochemical properties
- Extractables/leachables risk
- Residual curing agents/peroxides
- Metal catalysts such as platinum
- Material suitability for pharmaceutical contact applications
What changes to USP <87>, USP <88> Class VI, USP <665>, USP <381> and USP <383>, and what is the timeline?
What changes are happening to USP <87> effective 12/1/2026?
USP <87> Biological Reactivity Tests (In Vitro) will be officially updated on 12/01/2026.
Expanded emphasis on in vitro biological reactivity testing (cell-based cytotoxicity methods). This change is intended to support the reduction of animal testing and promote a modern, risk-based evaluation approach.
What changes to USP <88> Class VI effective 12/1/2026?
USP <88> Class VI Biological Reactivity Tests (In Vivo) will be used to regulate medical grade implant devices and thus will no longer be applicable to any of the products sold by Newman Sanitary Gasket Company. Testing for USP <88> Class VI has already ceased at the time of this statement and is no longer available for new compounds or compound revisions. The new revisions will be in effect December 1, 2026.
Traditional in vivo animal testing is being reduced and phased down in significance. The industry is moving away from relying solely on Class VI testing for biopharmaceutical manufacturing qualification.
When do these changes take effect for USP <665>?
USP <665> “Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products” will take effect on 05/01/2026.
When do these changes take effect for USP <381>?
USP <381> "Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems" will take effect on 12/01/2025.
When do these changes take effect for USP <383>?
USP <383> “Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components” will take effect on 12/01/2027.
What happens after these USP regulatory changes?
Newman Sanitary Gasket will implement the following approach:
|
Material Name |
Requirements Prior to 12/1/2026 |
Future USP Requirements |
|
· Plastic · Teflon® · Silverback™ |
· USP <87> · USP <88> Class VI |
· USP <87> (New 12/1/2026) · USP <665> (Took effect 5/1/2026) |
|
· Silicone |
· USP <87> · USP <88> Class VI |
· USP <87> (New 12/1/2026) · USP <383> (Takes effect 12/1/2027) |
|
· Other Rubber Materials o HNBR o EPDM o Viton® |
· USP <87> · USP <88> Class VI |
· USP <87> (New 12/1/2026) o USP <381> o No more animal testing. |
Existing vs. New Compounds
Existing Compounds: Concerning the 12/1/2026 updates to USP <87>, Newman Sanitary Gasket compounds that have already passed the current USP <87> do not require any additional testing. They will be “grandfathered in” according to the new regulations.
Changes to New Compounds: Any compound that undergoes a recipe change, raw material change, or process condition change will follow the new regulations and the relevant testing will be performed:
- New plastic materials (e.g., Teflon®, Silverback™) will require USP <665> and
the new USP <87> (12/1/2026) testing.
- New silicone materials will require USP <383> (12/1/2027) and the new USP <87> (12/1/2026) testing.
- New rubber materials (e.g., HNBR, EPDM, Viton®) will require the new USP <87> (12/1/2026) testing.
When are the new tests available?
The new regulation tests are available now.
What material is affected by the new USP regulations?
All new materials or reformulations that have not been previously certified to USP <87> and USP <88> Class VI will need to be certified under the new USP <87> (12/1/2026) regulations and other applicable USP regulations mentioned above.
Has Newman Sanitary Gasket’s materials passed the USP <87>/ USP<88> Class VI tests, and do they need to be retested?
Newman Sanitary Gasket’s compounds have already passed the current USP <87> and USP <88> Class VI. According to the new USP <87> (12/1/2026) regulations any materials that were previously certified to USP <87> will be “grandfathered in” and do not require any additional testing.
Will Newman Sanitary Gasket need to modify its materials to comply with the new regulations?
No, current Newman Sanitary Gasket compounds will be “grandfathered in” and maintain their current USP <87> certification. All current compounds that are certified to USP <87> and USP <88> Class VI will not need any further modifications to keep their certification(s).
Will there be any changes to Newman Sanitary Gasket’s part numbers?
There will be no changes to any part numbers at this time due to the changes in the regulations.
Will there be any changes to Newman Sanitary Gasket’s pricing?
There will be no changes to any part pricing at this time due to the changes in the regulations.
Contact Us
For any further questions or concerns, please feel free to reach out to us at:
Newman Sanitary Gasket Company
Phone: 513-932-7379
Website: www.newmangasket.com
Email: Customer@NewmanGasket.com
[i] The information contained herein is offered in good faith and is believed to be accurate at the time of writing. However, because conditions and methods of use of our products are beyond our control, this information should not be used in substitution for customer’s tests to ensure that our products are safe, effective, and fully satisfactory for the intended end use. NEWMAN SANITARY GASKET CO. (NSG) SPECIFICALLY DISCLAIMS ANY OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY. NSG DISCLAIMS LIABILITY FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES.