New Publication Helps Compounding Practitioners Ensure the Quality of Customized Preparations

June 26, 2012

To help ensure the quality of compounded medicines, the U.S. Pharmacopeial Convention (USP) has launched USP on Compounding: A Guide for the Compounding Practitioner, an electronic publication that includes all the compounding-related general chapters from the United States Pharmacopeia and the National Formulary (USP-NF).

Rockville, MD (PRWEB) June 26, 2012

To help ensure the quality of compounded medicines, the U.S. Pharmacopeial Convention(USP) has launched USP on Compounding: A Guide for the Compounding Practitioner, an electronic publication that includes all the compounding-related general chapters from the United States Pharmacopeia and the National Formulary (USP-NF). Compounding is the special preparation of a prescribed medicine. While compounding has been a traditional way of delivering medicines to patients for centuries, the practice has reemerged and grown steadily over the past two decades. This results from a variety of factors including special patient needs for customized therapies (e.g., allergen-free medications, nonstandard doses, and individualized parenteral nutrition), the need to access drugs or dosage forms withdrawn from the market for reasons other than safety or efficacy, and drug shortages.

USP on Compounding will be available for purchase through the USP store. Additionally, USP has partnered with the International Academy of Compounding Pharmacists (IACP) to sell copies directly to IACP members through the organization’s website (http://www.iacprx.org). USP on Compounding is offered as a 12-month electronic subscription in PDF format and will be updated with the release of each new USP-NF edition and supplement. Compounding practitioners in the US should be familiar with Federal and State requirements regarding standards in USP-NF and—by extension, USP on Compounding—to assure compliance with applicable requirements.

“As the need for good quality compounded medications grows, it’s important for compounding practitioners to have easy access to the standards that best support their practice,” said Roger L. Williams, M.D., USP’s chief executive officer. “This new publication will provide compounding pharmacists with the information they need in one location, enabling them to work more efficiently. Additionally, we are pleased to be offering this resource through IACP, which will allow direct access to the publication through the organization most compounding pharmacists look to for information.”

“As the healthcare system recognizes the value and importance of customized medication therapies to meet unique patient needs, the ancient art of compounding has transformed into a sophisticated, science based practice,” said David G. Miller, R.Ph., IACP’s executive vice president and chief executive officer. “IACP is proud to be a partner with USP in the launch of this new resource that gives pharmacists the standards, guidelines, and tools they need to advance their patient care services.”

USP on Compounding includes five compounding-related General Chapters:

•795 Pharmaceutical Compounding—Nonsterile Preparations: Provides guidance on applying good compounding practices in the preparation of nonsterile compounded formulations for dispensing and/or administration to humans or animals.

•797 Pharmaceutical Compounding—Sterile Preparations: Provides practice and quality standards for compounding sterile preparations.

•1160 Pharmaceutical Calculations in Prescription Compounding: Provides general guidance and assistance to pharmacists in performing the necessary calculations when preparing or compounding any pharmaceutical drug.

•1163 Quality Assurance in Pharmaceutical Compounding: Describes a quality assurance program as a system of steps and actions that must be taken to ensure the maintenance of proper standards in compounded preparations.

•1176 Prescription Balances & Volumetric Apparatus: Provides information about acceptable balances and volumetric apparatus (e.g., burets, pipets, cylinders, conical graduates, medicine droppers) used to weigh or measure medicinal and other substances required in prescriptions or in other pharmaceutical compounding.

In addition, USP on Compounding contains 46 supporting General Chapters referenced in the compounding-related chapters.

For more information, please visit http://www.usp.org or email mediarelations (at) usp (dot) org.

USP—Advancing Public Health Since 1820

The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP’s standards are recognized and used worldwide. For more information about USP visithttp://www.usp.org.

For the original version on PRWeb visit: http://www.prweb.com/releases/prwebUSPonCompounding/MM/prweb9639081.htm

U.S. Marshals seized misbranded drugs in Maine

FDA NEWS RELEASE

 

For Immediate Release: June 6, 2012

Media Inquiries: Pat El-Hinnaway, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

U.S. Marshals seized misbranded drugs in MainePortland company promoted their products for disease diagnosis, treatment 

On May 31, 2012, at the request of the U.S. Food and Drug Administration, U.S. Marshals seized drug products from Global Biotechnologies, Inc., of Portland, Maine, pursuant to a warrant issued by the U.S. District Court for the District of Maine.

 

According to the complaint, the company has made claims on its website, in promotional materials, and on the products’ labels that its products can diagnose, cure, mitigate, treat or prevent human diseases. The company’s products, including Glucanol, Healthy Trac, Immunol, and Lactopril, meet the FDA definition of drugs because Global Biotechnologies promoted them to treat diseases. However, the company failed to provide adequate directions for use for its drug products, causing those products to be misbranded drugs in violation of the Federal Food, Drug and Cosmetic Act.

 

“The public relies on the FDA to keep companies from claiming that their products improve medical conditions or diseases,” said Armando Zamora, acting director, office of enforcement, in the Office of Regulatory Affairs. “Using these products in the mistaken belief that they will cure a disease – especially when they cannot do so – represents a danger to the public’s health.”

 

Earlier, the FDA sent a warning letter to Global Biotechnologies advising the company that making treatment claims on its labels, promotional materials and websites caused the products to be unapproved new drugs and misbranded drugs in violation of the Federal, Food, Drug and Cosmetic Act. At that time, the company committed to removing drug claims cited in the warning letter from its labeling. However, during a recent inspection, the FDA found that the company had continued to make illegal claims that cause their products to be misbranded drugs.

 

No illnesses have been associated to date with Global Biotechnologies’ products. Illnesses or adverse events related to use of these products should be reported to the FDA at caers@fda.hhs.gov or by calling 240-402-2405.

 

For more information:

• FDA Warning Letter, Feb. 8, 2006

 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.

CDER Sponsored Meetings, Conferences and Workshops

Meetings, Conferences, & Workshops (Drugs)

The following are meetings, conferences, and workshops sponsored or co-sponsored by the Center for Drug Evaluation and Research (CDER):

Upcoming 

• FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2012, June 19-20, 2012
• DIA/FDA: Revitalizing Productivity in Drug Development, October 23, 2012, 5151 Pooks Hill Road, Bethesda, MD. Meeting
• The Regulatory Convergence, October 26–30, 2012, Seattle, WA. 
• CDER Forum for International Drug Regulatory Authorities, November 5-9, 2012, College Park, MD. 
• PDA Pharmaceutical Quality Systems (ICHQ10) Conference, November 15-16, 2012
•  

For more information on these meetings, click here.