Ensuring quality for homeopathic products
The growing number of homeopathic products sold in the drug channel has captured the attention of many retailers and others. As the demand for less processed products in all categories likely is to continue and grow stronger, it is doubtful that the resurgence of this 200-year-old system of medicine known for its safety profile is merely a trend. Indeed, it may be a new beginning.
Those new to homeopathic drugs may ask, “What needs to be known to stay in regulatory compliance and stay out of trouble as demand and innovation in this niche push compliance past current boundaries and attract the attention of Food and Drug Administration?” Competition always has been viewed as good for innovation, yet progress needs to be built on a solid foundation. Newcomers do not have the decades of technical experience necessary to work with homeopathic medicine’s infinitesimal active ingredients, or the detailed knowledge of the regulatory requirements of this over-the-counter drug category.
In recent years, the FDA has issued warnings to retailers for private-label OTC drugs, as well as their manufacturer, so it is best if staff for both entities have a full understanding of requirements and limitations. Retailers and entrepreneurs would be wise to vet which contract manufacturers are familiar with the standards of the Homeopathic Pharmacopoeia of the United States, drug Good Manufacturing Practices and the FDA’s proposed homeopathic drug guidance that most likely will be approved soon.
As for contract manufacturers, FDA has said they are responsible for whatever goes out their doors. They need to make products as if their own name was on the label because, in the eyes of the law, it is. This is regardless of the retailer or entrepreneur creating the formula and designing the label, or whether the manufacturer advised that the product and package did not comply. In fact, FDA can hold these manufacturers responsible, even if their manufacturing contract terms place liability with the labeler.
To ensure retailers that manufacturers are best serving the public and their homeopathic products comply and are up to date with the latest regulations, the American Association of Homeopathic Pharmacists is hosting a one day educational event in Baltimore this summer. The AAHP Summit is of interest to manufacturers and retailers alike.
Retailer staff who review products for compliance and acceptance into their franchise will benefit from attending the AAHP’s Summit on Challenges & Solutions in Quality & Safety of Homeopathic Drug Products. Quality control and assurance staff, as well as toxicologists and pharmacovigilance staff, responsible for safety at retailers’ contract manufacturers should attend, as should those responsible for legal review and marketing claims.
An AAHP inaugural industry reception on June 27 will precede the June 28 educational summit. This special evening reception will include remarks from such thought leaders as Scott Emerson of the Emerson Group on the state of homeopathic products at the retail level and networking with senior executives from the industry.
Since 1923, AAHP has promoted excellence in the practice of homeopathic pharmacy, manufacturing, marketing and distribution by supporting the requirements, criteria and published guidelines in the HPUS and relevant federal statutes, as well as other industry regulations/compendia, all to help members provide safe, effective homeopathic medicines.
To register for the three-track safety, quality and regulatory summit or the industry reception being held in conjunction with the Joint American Homeopathic Conference, visit jahc2019.org/aahp-summit.html.
Mark Land is president of the American Association of Homeopathic Pharmacists and vice president of government and regulatory affairs for Boiron USA
Those new to homeopathic drugs may ask, “What needs to be known to stay in regulatory compliance and stay out of trouble as demand and innovation in this niche push compliance past current boundaries and attract the attention of Food and Drug Administration?” Competition always has been viewed as good for innovation, yet progress needs to be built on a solid foundation. Newcomers do not have the decades of technical experience necessary to work with homeopathic medicine’s infinitesimal active ingredients, or the detailed knowledge of the regulatory requirements of this over-the-counter drug category.
In recent years, the FDA has issued warnings to retailers for private-label OTC drugs, as well as their manufacturer, so it is best if staff for both entities have a full understanding of requirements and limitations. Retailers and entrepreneurs would be wise to vet which contract manufacturers are familiar with the standards of the Homeopathic Pharmacopoeia of the United States, drug Good Manufacturing Practices and the FDA’s proposed homeopathic drug guidance that most likely will be approved soon.
As for contract manufacturers, FDA has said they are responsible for whatever goes out their doors. They need to make products as if their own name was on the label because, in the eyes of the law, it is. This is regardless of the retailer or entrepreneur creating the formula and designing the label, or whether the manufacturer advised that the product and package did not comply. In fact, FDA can hold these manufacturers responsible, even if their manufacturing contract terms place liability with the labeler.
To ensure retailers that manufacturers are best serving the public and their homeopathic products comply and are up to date with the latest regulations, the American Association of Homeopathic Pharmacists is hosting a one day educational event in Baltimore this summer. The AAHP Summit is of interest to manufacturers and retailers alike.
Retailer staff who review products for compliance and acceptance into their franchise will benefit from attending the AAHP’s Summit on Challenges & Solutions in Quality & Safety of Homeopathic Drug Products. Quality control and assurance staff, as well as toxicologists and pharmacovigilance staff, responsible for safety at retailers’ contract manufacturers should attend, as should those responsible for legal review and marketing claims.
An AAHP inaugural industry reception on June 27 will precede the June 28 educational summit. This special evening reception will include remarks from such thought leaders as Scott Emerson of the Emerson Group on the state of homeopathic products at the retail level and networking with senior executives from the industry.
Since 1923, AAHP has promoted excellence in the practice of homeopathic pharmacy, manufacturing, marketing and distribution by supporting the requirements, criteria and published guidelines in the HPUS and relevant federal statutes, as well as other industry regulations/compendia, all to help members provide safe, effective homeopathic medicines.
To register for the three-track safety, quality and regulatory summit or the industry reception being held in conjunction with the Joint American Homeopathic Conference, visit jahc2019.org/aahp-summit.html.
Mark Land is president of the American Association of Homeopathic Pharmacists and vice president of government and regulatory affairs for Boiron USA