GENERAL PROVISIONS

The aim of this chapter is to establish requirements that address the specific regulatory obligations of the dietary supplement industry and the additional requirements necessary to achieve compliance with the USP–NF quality specifications. The chapter covers the process, facilities, and controls to be used in the manufacturing, packaging, labeling, holding, and distributing of dietary supplements consistent with the FDA current good manufacturing practices (cGMP) regulations in title 21, part 111 of the Code of Federal Regulations in order to help dietary supplement manufacturers ensure that dietary supplements are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification according to USP standards.