Magazine article Drug Topics

Pharmacy Licensure

Magazine article Drug Topics

Pharmacy Licensure

Article excerpt

How compatible is your license with your business activity?

Increasingly, retail pharmacies are becoming involved with new business opportunities that go beyond the traditional dispensing of drugs to patients in a retail setting. As technology and professional innovation both evolve, the pharmacy profession is moving forward into areas of patient treatment that involve complex compounding methods, specialty pharmaceutical drugs and related supply-chain issues, and even new types of practitioneradministered medications, among other things.

One area of significant legal concern for any dispensing pharmacy engaged in activity that goes beyond its perceived licensure mandate is whether it possesses the requisite license for any expanded business activity in which it is engaged.

A simple ex- ample is the case of a retail phar- macy that seeks to act as a whole- sale distributor of drug product to another pharmacy or even a health- care practitioner (quite pos- sibly with no identifiable patient at the time of drug sale). Such a pharmacy very likely should possess an addi- tional wholesale distribution license separate and apart from its state-is- sued retail phar- macy license. Another more difficult example indudes whether a third-party lo- gistics provider is required to have a wholesale dis- tribution license when directing products for a manufacturer.

Because drug supply- chain dispensing/distribution activities are typically driven by state law, a state-specific legal analysis must be undertaken for the state in question, in order to determine the licensure require- ments for the business activity being practiced. If drug supply-chain activities are crossing state lines, the laws and regulations of each state in question should be analyzed to ensure Ml compliance with law is being achieved. In some cases, depending on the nature of the business activity, federal law should also be reviewed. …

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