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As the number of people using homeopathic medicines has increased, the FDA has appropriately paid more attention to its regulations for "Good Manufacturing Practices" and their enforcement. Internationally accepted guidelines for the manufacture of all drugs have always required that all manufacturers have adequate quality systems. Such systems are expensive and require rigorous ongoing documentation.

FDA’s regulatory standards have evolved with changes in pharmaceutical science and technology. Those standards are appropriate for conventional drug products. However, they can be problematic when applied to certain unique aspects of homeopathic drug manufacturing. In response, the Convention has expanded its efforts to harmonize with those standards of FDA which are appropriate, while continuing to preserve the uniqueness of homeopathy.

The Convention’s volunteers all have expertise in aspects related to homeopathic drug product manufacture and use. The above challenges have created a need for hiring outside consultants with other expertise to address our ongoing work with the FDA. However, this need coincides with a decrease in outside funding that previously supported such efforts.

The overall homeopathic industry has seen remarkable shifts in the makeup of firms actively engaged in producing homeopathic drug products, with a more than 50% change in companies during the last 5-7 years. More companies are marketing and fewer are manufacturing. One hidden result has been a loss of capacity in the manufacturing sector which impacts the consumer's access directly because it creates a lack of availability of some products. It affects the Convention due to a loss of firms subscribing to the HPUS. In addition, it results in a smaller pool of expertise within the industry that can provide meaningful information and ideas for issues affecting the Convention.