Revisions to USP–NF General Chapter '2750' on Manufacturing Practices for Dietary Supplements Proposed

Revisions intended to include botanicals

Rockville, Md., May 14, 2002—The United States Pharmacopeia (USP) has proposed in the March–April Pharmacopeial Forum 28(2) revisions to the General Chapter '2750' Manufacturing Practices for Nutritional Supplements in the United States Pharmacopeia 25 and the National Formulary 20 (USP 25–NF 20). The General Chapter pertains to manufacturing practices for dietary supplements. Of importance is changing the chapter’s title to Manufacturing Practices for Dietary Supplements as well as providing methods to be used in, and the facilities and controls to be used for, the manufacture of all dietary supplements. The intention of the proposed revisions to the General Chapter are to help ensure that all dietary supplements meet requirements for strength, quality and purity.

“We decided to change the chapter’s title to incorporate botanicals since the original chapter supported monographs only for multivitamins, mineral preparations, and other nonbotanicals,” said Dr. Gabriel Giancaspro, scientist at USP. “Since the Dietary Supplements Health and Education Act of 1994 (DSHEA) recognizes botanical preparations, we knew we needed to introduce provisions pertaining to botanical preparations within the General Chapter.”

The proposed revisions to the General Chapter pertain to organization and personnel functions; grounds, buildings and facilities; raw materials, product containers, and closures, and testing and approval or rejection in the manufacturing process for dietary supplements. Of particular interest in the chapter is a section that focuses on raw material usage in the dietary supplement manufacturing process. This section focuses on issues concerning raw materials and product containers and closures; production and process control; and sampling and testing. In addition, other revisions of importance in the General Chapter are labeling and packaging; shelf dating life, and quality control operations. The General Chapter also includes a glossary of terms that are commonly used in manufacturing practices for dietary supplements.

Comments on the revisions made to the General Chapter should be addressed and mailed by Oct. 15, 2002 to Dr. Gabriel Giancaspro at USP, 12601 Twinbrook Parkway, Rockville, MD 20852. Additional questions pertaining to manufacturing practices for dietary supplements can be e-mailed to [email protected].

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USP is a non-government organization that promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies. These standards are developed by a unique process of public involvement and are recognized worldwide. USP has three additional public health programs focusing on promoting optimal health care, including the Dietary Supplement Verification Program (DSVP), Health Care Information, and Patient Safety. USP is a not-for-profit organization that achieves its goals through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations.

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