New Finalized Manufacturing Guidance in HPUS

The HPUS contains a newly approved set of Guidelines for Manufacturing Homeopathic Medicines that will affect every manufacturer and marketer of homeopathic drug products in the USA. All companies should familiarize themselves with these changes before the final implementation date to ensure a smooth and trouble free transition.

The Guideline document is the result of 5 years of work by the Council on Pharmacy (CoP), and was posted for comment in Spring 2013. After a six month public comment, the CoP reviewed the comments received and made editorial and content changes in the draft document and recommended to the Board of Directors final adoption of this Guideline. The Board of Directors approved the recommendations at the January 2014 meeting and has posted this Guideline this April. In order to provide the industry with adequate time to review the new guidelines and implement any necessary changes, a final implementation date of 31 March 2017 applies to the new Guidelines, at which time they will officially replace the existing General Pharmacy Section.