New Law Curbs "Rogue" Internet Pharmacy Activity

Article excerpt

Teenager's death led to act of Congress

The Ryan Haight Online Pharmacy Consumer Protection Act, legislated and signed into federal law in 2008, is named for a teenager whose death resulted in part from the ease with which he acquired a narcotic drug over the Internet without a valid prescription. Haight was able to sign onto an Internet site posing as a legitimate pharmacy. He purchased a narcotic drug, which was delivered to his house, where he consumed the drug and died.

The act amended the Controlled Substances Aa (part of 1970's Comprehensive Drug Abuse Prevention and Control Act) to prohibit delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription. The amendments included a definition of "online pharmacy" as well as registration, reporting, and Web site disclosure requirements for online pharmacies.

Of particular importance is the requirement that each online pharmacy obtain from the Drug Enforcement Administration (DEA) a modification of its DEA pharmacy registration expressly authorizing the operation of an online pharmacy.

On April 6, 2009, the DEA issued an interim final rule implementing the act and requested public comment on the rule in the Federal Register. According to the DEA rule, the modified registration requirement took effect on April 13,2009.

The art and rule set forth a broad definition of an online pharmacy, as well as nine exceptions that exclude certain categories of pharmacies from this definition. "Online pharmacy" is defined as "a person, entity or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, dispenses, or offers, or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet."

On the basis of this broadly drafted definition, most pharmacies (including name-brand pharmacies) providing Internet access to customers are likely to be deemed online pharmacies, subject to the modified registration and related requirements of act and rule, unless they can satisfy one or more exceptions to this definition. The definition also raises the question of the act's crossborder jurisdictional reach in countries with no reciprocity with the United States.

Thankfully, act and rule include multiple exceptions to the definition of an online pharmacy. For example, pharmacies for which Internet dispensing of controlled substances is related to refilling Classes m, IV, and V controlled substances are exempt from the DEA's registration modification requirements. …