The dispensing of prescription (legend) drugs and devices directly to patients pursuant to a prescription issued by a licensed practitioner with prescriptive authority is an activity which has been regulated by the legislature for many years. At this writing there are four professions authorized to conduct such activities - dentistry, medicine, pharmacy, and veterinary medicine - and each of those professions are regulated by their respective practice acts passed by the state legislature. With respect to pharmacy, the Pharmacy Practice Act requires any person or firm dispensing legend drugs or devices directly to patients pursuant to prescriptions to obtain a pharmacy permit from the Board prior to engaging in that activity.
The requirements for a pharmacy permit reflect concern for the presence of prescription drugs, including narcotics and other controlled substances; the minimum specifications include environmental integrity standards and security standards for the storage of drugs as well as staffing requirements for the presence of a pharmacist at all times the pharmacy is open for business. The Board has been made aware of a growing number of providers that elect to focus on the provision of legend devices to the exclusion of legend drugs. With the premise that firms electing to provide legend devices to the exclusion of legend drugs probably do not require the same level of standards applicable to firms providing legend drugs, the Board has been working on a new credential that could be developed and issued to providers who furnish legend devices to the exclusion of legend drugs. Once the Board could approve the new credential and the applicable standards of practice, it would then conduct the formal rulemaking process, which ordinarily requires four or five months to complete.
Recent actions by the federal Centers for Medicare and Medicaid Services (CMS) prompted the Board to recognize the urgent need for immediate action. During the Board's May 2, 2012 meeting, the Board issued a Declaration of Emergency that suggested the necessity of an Emergency Rule. The emergency rule is valid for a maximum of 120 days or until the formal rulemaking process is concluded, whichever shall first occur. The emergency rule creates the Durable Medical Equipment (DME) Permit, defines the scope of authority, identifies the standards of practice, and delineates the persons and firms exempted from the credentialing requirement. The declaration of emergency permits the Board to immediately begin accepting applications and issuing permits while the Board also begins the formal rulemaking process to permanently establish the credential and standards of practice.
We encourage those persons and firms with an interest in this topic to monitor the Board's progress in the formal rulemaking process by routinely visiting the Public Notices section of the Library on this website.
For the Board:
Malcolm J Broussard