Ned Milenkovich, PharmD, JD

The act amended the Controlled Substances Act (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.

The act 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 cross-border 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 III, IV, and V controlled substances are exempt from the DEA's registration modification requirements.

In particular, the act and rule provide that the term, online pharmacy, does not include a pharmacy registered under Section 303(f) of the Controlled Substances Act when its dispensing of controlled substances over the Internet consists solely of refilling prescriptions for controlled substances in Schedule III, IV, or V.

To satisfy this exception, the dispensing must be in accordance with refill instructions issued by a practitioner as part of a valid prescription that satisfies the Controlled Substances Act and regulations, and it must not include issuance of a new prescription for a controlled substance that was previously prescribed for the individual.

Other exceptions abound. The rule also provides that in order for a prescription to be considered valid, the prescription must be issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least one in-person medical evaluation of the patient, or by a covering physician. DEA has interpreted this narrowly, however, and has stated that one visit to a physician over a protracted time frame is not likely to satisfy this requirement. Nevertheless, the manner in which the rule is drafted makes such a requirement unclear and open to debate.

Very few pharmacies have rushed to modify their DEA registration based on their Internet activities, and the overwhelming majority of pharmacies should properly fall within one of the enumerated exceptions set forth in the act and rule.

Nevertheless, the adage "an ounce of prevention is worth a pound of cure" applies squarely in this case. Pharmacies participating in Internet drug activity should take steps to inquire whether they are compliant with the new DEA obligations.

Pharmacies should also check with state boards of pharmacy to ensure that they have proper licensure and permits when engaging in the dispensing and shipping of drugs over the Internet.

Ned Milenkovich is a member at McDonald Hopkins LLC, where he chairs the Drug & Pharmacy Group. He is also a member of the Illinois State Board of Pharmacy. He can be reached at 312-642-1480 or by e-mail at nmilenkovich@mcdonaldhopkins.com
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