Compendial Compliance

The US Pharmacopeial Convention posted a proposed revised standard for what should and should not appear on the ferrules and cap overseals of medication vials.

In response to a request from the US Food and Drug Administration, the US Pharmacopeial Convention (USP) revised its standards for propylene glycol and sorbitol solution

A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.

The authors used a light-transmission-based static division system to detect particles of foreign contaminants in prefilled vials.

Also, USAID and USP launch counterfeiting public service campaign in Cambodia.

The US Food and Drug Administration issued an alert to healthcare professionals of a change in heparin manufacturing that is expected to decrease the drug's potency.

The US Pharmacopeial Convention (USP) and the Permanent Commission of the Pharmacopeia of the United Mexican States (FEUM) signed a memorandum of understanding (MOU) last week.

The US Pharmacopeia is revising its monographs for four pharmaceutical excipients: propylene glycol, sorbitol solution, sorbitol sorbitan solution, and noncrystalllizing sorbitol solution.

This week, the US Pharmacopeial Convention and the Vietnamese Pharmacopoeia Commission signed a memorandum of understanding that will help ensure the safety of Vietnamese medicines.

Traditional Chinese Medicine is widely used, but questions persist regarding its regulatory status.

The author provides a history of the information chapter USP ‹1211› "Sterilization and Sterility Assurance of Compendial Articles," from the early 1900s to the current version.

The United States Pharmacopeial (USP) Convention signed a memorandum of understanding (MOU) with the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) last week in Moscow.

Standards data is helpful, but FDA needs to apply its information across the board. This article contains bonus online-exclusive material.

The US Pharmacopeial Convention (USP) and the National Institute for the Control of Pharmaceutical Biological Products (NICPBP), China's agency for overseeing the quality of large- and small-molecule drugs, signed a memorandum of understanding (MOU) to bolster the quality of medicines in China and in the countries that buy Chinese drug products, including the United States.

An updated book provides essential information for scientists who monitor microbial quality.

The US Pharmacopeial (USP) Convention has announced new standards for heparin and glycerin.

USP <231> Heavy Metals is transitioning toward the incorporation of modern quantitative technologies, but there is still much to be resolved.

After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region's short- and long-term role? This article contains bonus online-exclusive material.

US marshals seized 11 lots of heparin from Celsus Laboratories (Cincinnati, OH) at the request of the US Food and Drug Administration.

This position paper describes a model for the future that would provide appropriate standardization, facilitate drug registration and support regulatory agencies.

Attendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.

Scott Sutton discusses the current state of USP ‹1117› and USP's plans for future revisions.

This article summarizes the classification systems for topical liquid and semisolid dosage forms used for dermatological application and notes some differences between FDA and USP classification.

USP announced an interim revision to its monograph for levothyroxine sodium tablets, which will become official in USP 32-NF 27.

The US Pharmacopeial Conventional added to its international sites with the official opening of its facility in Sao Paulo, Brazil.

USP's guideline for pending monographs can speed up publication of monograhs and time to market.

The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.

The European Pharmacopoeia Commission adopted revised monographs for heparin calcium and heparin sodium to strengthen the level of testing required for quality control.

After a one-year delay in its implementation, the US Pharmacopeia Chapter 467 "Residual Solvents" is now official.

The US Pharmacopeia (USP) posted revised monographs for heparin sodium and heparin calcium on its website.