The FDA has proposed a Rule that would codify the existing 5 percent “minimum quantity” rule, which states that pharmacies can sell up to 5 percent of their total annual prescription drug sales volume to licensed professionals for office use. This means that pharmacies that sell drugs to entities other than licensed practitioners for office use will be considered wholesalers, regardless of whether sales fall below the 5 percent minimum quantity threshold. The State Board of Pharmacy is responsible for licensing all wholesalers, and it is up to the board's discretion to decide who is a wholesaler based on factors such as advertising, location, method of doing business, and sales representation. It is also a violation punishable by a fine not exceeding two hundred and fifty dollars to distribute free samples of any medication, other than a cosmetic not intended to be ingested, to any residential home without proof that it is administered directly to a person over 18 years of age.
The proposed Rule would apply to stakeholders beyond traditional wholesalers, such as pharmacies, drug manufacturers and other business partners of prescription drug products that maintain various types of licenses. Co-located pharmacies and wholesale distributors are subject to additional scrutiny, which may require additional documentation to demonstrate compliance with state and federal laws and the drug distributor accreditation criteria. The executive secretary of the board must be a pharmacist licensed in the state for at least five years. Virtual wholesale distributors are applicants who sell a prescription drug or device but never physically own the product.
Pharmacies that maintain pharmacy distribution centers may also be licensed as wholesalers and will be subject to the proposed rule.