Regulatory Compliance

Wise Men Healing Balm is a "homeoopathic" remedy made for minor pain relief manufactured by Neutripure Corporation in Saint Paul, Minnesota.   Neutripure complies with current drug Good Manufacturing Practices (cGMP)

Homeopathic remedies have been classified as “drugs” since their inclusion in the Federal Food, Drug, and Cosmetic Act in 1938 the HPUS and are recognized by the FDA, which regulates the manufacture, marketing and sales of all homeopathic medicines in the United States.

Homeopaths consider the body’s own defense mechanism to be the optimal healing system.  The properly selected homeopathic medicine stimulates these defenses to work more effectively.

The main topics covered by regulations are:  standard operation procedures, quality control testing for raw materials (including identification), calibration of all testing equipment, cleaning validations, manufacturing process validations, blend uniformity, stability studies, finish product testing, personnel training records, annual product reviews,  change controls, out of specifications, adverse reactions reporting, batch log reporting, corrective actions preventive actions, internal audits, etc.