USP Revises Select Chemical Standards
Summary
The USP has announced revisions to the chemical information of select standards, with updates becoming official on October 1, 2026. These changes affect specific USP monographs for various drug substances and formulations, including Candesartan Cilexetil and Hydrochlorothiazide Tablets, Dronabinol, and several Verapamil Hydrochloride products.
What changed
The United States Pharmacopeia (USP) has issued a notice announcing revisions to the chemical information for several drug standards. These updates, highlighted in yellow within the respective USP monographs and marked with '(CN 1-Oct-2026)', will officially take effect on October 1, 2026. The revisions impact monographs for Candesartan Cilexetil and Hydrochlorothiazide Tablets, Dronabinol, Insulin Lispro, Nitrofurazone, Octinoxate, Paclitaxel Injection, Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, Triamterene Capsules, and various Verapamil Hydrochloride formulations.
Manufacturers and quality control departments relying on these USP standards must review the updated monographs by the effective date of October 1, 2026. Compliance with these revised chemical standards is necessary to ensure product quality and regulatory adherence. While these are updates to compendial standards and not new regulations, adherence is critical for products marketed in the US that claim USP compliance.
What to do next
- Review updated USP monographs for affected drug substances and formulations.
- Ensure internal quality control processes and documentation align with revised chemical standards by October 1, 2026.
Source document (simplified)
Chemical Information Updates
Type of Posting: Publication Announcement
Posting Date: 27-Mar-2026
Targeted Official Date: 1-Oct-2026
Expert Committee: Various
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that USP intends to revise the Chemical Information of select standards in accordance with the General Announcement published on March 25, 2022.
USP will publish Chemical Information updates on March 27, 2026. The updated standards will be official on October 1, 2026. The changes will be highlighted in yellow and followed by the notation (CN 1-Oct-2026) in the updated standards.
The impacted standards are as follows:
- Candesartan Cilexetil and Hydrochlorothiazide Tablets (USP Monograph)
- Dronabinol (USP Monograph)
- Insulin Lispro (USP Monograph)
- Nitrofurazone (USP Monograph)
- Octinoxate (USP Monograph)
- Paclitaxel Injection (USP Monograph)
- Trandolapril and Verapamil Hydrochloride Extended-Release Tablets (USP Monograph)
- Triamterene Capsules (USP Monograph)
- Verapamil Hydrochloride (USP Monograph)
- Verapamil Hydrochloride Extended-Release Capsules (USP Monograph)
- Verapamil Hydrochloride Extended-Release Tablets (USP Monograph)
- Verapamil Hydrochloride Injection (USP Monograph)
- Verapamil Hydrochloride Tablets (USP Monograph) Should you have any questions, please contact Elena Gonikberg, Sr. Principal Scientist (eg@usp.org).
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Pharma & Drug Safety alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when USP Compendial Notices publishes new changes.