Online pharmacies that ship medications and/or medical equipment to consumers are known as “mail order pharmacies”. Mail order pharmacies are regulated at both the state and federal level as the government has a compelling interest in protecting consumers from the potentially harmful effects of dispensing medications.
Although licensing requirements vary by state, the general rule is that a mail order pharmacy must obtain a license in each state in which it dispenses medication. In other words, the licensing rules and regulations in the state in which the consumer or patient is located governs, regardless of where the mail order pharmacy is physically located. For example, if a mail order pharmacy is physically located in and ships medication out of Mississippi, but dispenses to consumers in all 50 states, it must not only first obtain a “home state license” in Mississippi, but it also must obtain and abide by the licensing requirements in each of the 50 states where its consumers are located.
Each state varies with respect to how onerous (or not) obtaining a license is. Depending on the type of medication and/or supplies being dispensed, multiple licenses within one state may be required. For example, any pharmacy that dispenses controlled substances generally must also obtain a DEA registration in that state. This is typically an extension from the basic pharmacy license application. If the pharmacy solely dispenses medical equipment, a DME license, or pharmacy license, or both may be required, depending on a particular state’s rules and regulations. The process of obtaining these licenses can be cumbersome, but it is vital to the overall compliance and operations of a pharmacy. The penalties that can result from non-compliance are extreme. Failure to obtain, renew, or report a change of ownership associated with the appropriate license could subject the pharmacy to fines, revocation of a license, or denial of a future license. Failure to properly obtain DEA registration could subject the pharmacy to criminal prosecution. The attorneys at Florida Healthcare Law Firm offers full support through all stages of the licensing process. We make identifying, preparing and filing the applications easy and act as a liaison to the licensing authorities on the pharmacy’s behalf to assure the upmost compliance.
