November 22, 2011

STANDARDS

Expert Committee Work Plans—USP's Council of Experts and its 21 Expert Committees provide the scientific foundation for USP's public health products and programs. Updated information on these standard setting bodies, including their focus areas, work plans, committee members, government liaisons, and USP staff contacts, is now available. USP contemplated this type of transparency as part of Resolution 2, Core Compendial Activities, and we are pleased to offer access to this information on our website.

Modernized Standards for Positron Emission Tomography (PET) Drugs—Revised standards for PET drugs will appear in the November 2011 USP 35-NF 30 and become official on May 1, 2012.  General Chapter <823> Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses covers radioactive drugs administered to patients when enhanced images of internal organs and tissues are needed. PET drugs contain a small amount of radioactive material and must be administered within a few hours of their production.  USP’s new chapter seeks to ensure the identity, strength, quality and purity of PET drugs during their entire life cycle.  

HEADQUARTERS

USP CEO Comments on U.S. Dietary Supplement Regulation—Dr. Roger Williams responded to a commentary on public health challenges associated with U.S. dietary supplement regulations in a Letter to the Editor published in a recent issue of the Journal of the American Medical Association.  Under current U.S. law, manufacturers who do not claim compliance with USP-NF dietary supplement standards are not required to meet these standards.  Dr. Williams discusses voluntary verification programs and actions that consumers can take to encourage manufacturers to embrace public quality standards.

Dr. Williams Focuses on OTCs in Pharmaceutical Executive Magazine—In a recent column, USP CEO Roger L. Williams, M.D., explains the complexity of setting quality standards for over-the-counter medicines in the U.S. USP, FDA, and the Consumer Healthcare Products Association (both USP Member organizations) are working with manufacturers to modernizie standards and develop new approaches to ensure patients and consumers are safe.

INTERNATIONAL

Ukrainian Administration Strengthens Commitment to Good Quality Medicines—USP has signed a memorandum of understanding (MOU) with the State Administration of Ukraine on Medicinal Products to work collaboratively on:

  • Increasing awareness, through advocacy and promotion, about the quality and safety of medicines,
  • Developing a long term strategy to ensure that medicines of assured quality and safety are available to the public, and
  • Fighting the presence of counterfeit and substandard medicines.

Russian Translation of USP-NF Updated—An update to the existing Russian translation of USP-NF was released by USP at a recent pharmaceutical conference in Moscow.  The new publication includes many monographs, chapters, and selected updates published since the earlier translation was completed. 

USP to Collaborate with Chilean Pharmacopeia—In its efforts to strengthen ties with other pharmacopeias throughout the world, USP and the Chilean Pharmacopoeia Foundation (CPF) signed an MOU that focuses on:

  • Developing reference materials to demonstrate compliance with pharmacopeial standards,
  • CPF adopting or adapting USP-NF for use in Chile, and
  • Sharing expertise through joint meetings and courses, visiting scientists, and publications.