Development of a Third Party Accredited Standards Process

The NHPCB (National Homeopathic Product Certification Board) has had regular contact with the Food and Drug Administration (FDA) and shared our draft work on standards with the agency.  The FDA’s Center for Drug Evaluation and Research has indicated that the agency would welcome the opportunity to participate in a third-party accredited standards development process and asked that we begin our certification process based on those future standards.

Working with the NSF

In response to the FDA, the NHPCB is contracting with NSF a nationally recognized standard-setting organization, to conduct an accredited standards development process. The process, which will be funded by the NHPCB, will start by seating a Joint Committee open to all stakeholders, which will convene on a regular basis to review, amend, and revise a set of voluntary consensus standards uniquely suited to the manufacturing and labeling of homeopathic drug products.  Having an existing set of model standards will serve to shorten the process (active link). The NSF has considerable experience in supporting joint committees and working to create nationally recognized and accredited consensus standards.

Convening the Joint Committee

We anticipate the process will take two years and will include approximately 30 voting members, in addition to many non-voting observers and subcommittee members.   The NSF will be opening up this process for application to anyone who wishes to participate.  An application is submitted to NSF and reviewed for appropriateness, conflicts of interest and balance in terms of committee composition.  Participation can be as a voting committee member, as an observer or participant on subject matter expert committees.

The process is designed to be public and transparent and represent the entire homeopathic community.  Everyone participating as a voting member will have an equal voice.

Participants on the Joint Committee will come from three separate categories which will be equally represented.  This includes the following:

  • Industry: A member who produces, assembles, distributes or sells materials, products, systems or services covered by the scope of the standard under the purview of this committee (Distributor, Industry Trade Association, Manufacturer of products or ingredients, Manufacturer of Processes);
  • Public Health/Regulatory: A member who is from a public agency (Academic or Educational Institution, Government, Military, Model Code Organization, Professional Public/Environmental Health/Safety Organization, Public Agency Having Regulatory Authority for Products);
  • User: A member who purchases or uses products covered by the scope of the standard (s) under the purview of the committee. A member who represents an organization that provides for-profit services covered by the scope of the standard(s) under the purview of this committee. (Auditor, Certification Organization or Test laboratory, Consultant, Consumer/User of Products, Retailer, Training Provider, User/Consumer Trade Organization).