Congress Passes Legislation To Regulate Controlled Substance Dispensing Over the InternetOctober 15, 2008
In an effort to eliminate rogue pharmacies from dispensing controlled substances over the Internet, Congress passed legislation amending the Controlled Substances Act (“CSA”). The Ryan Haight Act (H.R. 6353), which honors a teenager who died of an overdose of controlled drugs obtained over the Internet, awaits President Bush’s signature. The legislation follows the recent Drug Enforcement Administration (“DEA”) crackdown on Internet pharmacies and distribution of controlled substances to those pharmacies.
The Act would permit DEA to register only certain pharmacies meeting specific criteria to dispense controlled substances over the Internet. In summary, the Act would prohibit dispensing controlled substances by means of the Internet unless:
1. The patient has a “valid prescription;”
2. DEA has modified the pharmacy’s current DEA registration to dispense via the Internet. (It is unclear whether the Act would require Internet pharmacies to first register and then obtain a modification to their registration or if “online pharmacy” will be a separate category of registrant on the registration application.);
3. The pharmacy reports to DEA the quantity dispensed over the Internet if it dispenses 100 prescriptions or 500 or more dosage units in a month;
4. The pharmacy notifies DEA 30 days prior to offering to sell, deliver, distribute or dispense controlled substances over the Internet; and
5. The pharmacy certifies that it complies with the Act and posts its name, address, telephone number and pharmacist in charge on its homepage.
The Act would also enhance penalties for the illegal distribution of schedule III-V controlled substances and provide state Attorneys General with the ability to bring civil action in federal district court to enjoin Internet pharmacies.
The Act prohibits controlled substances from being “delivered, distributed or dispensed by means of the Internet without a valid prescription.” The Act defines “valid prescription” as “a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by . . . a practitioner who has conducted at least 1 in-person medical evaluation of the patient . . . or a covering practitioner.” An “in-person medical evaluation” is a “medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.” A “covering practitioner” is “a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who . . . has conducted at least 1 in-person medical evaluation of the patient or an evaluation through the practice of telemedicine, within the previous 24 months . . . and is temporarily unavailable to conduct the evaluation of the patient.”
To “deliver, distribute, or dispense by means of the Internet refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet.”
An “on-line” pharmacy is an entity or Internet site that “knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet” but does not include registered manufacturers or distributors who do not dispense to unregistered individuals or entities; registered nonpharmacy practitioners; hospitals or medical facilities operated by U.S. agencies; “mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance;” or a registered pharmacy “whose dispensing controlled substances via the Internet consists solely of” filling or refilling schedule III-V prescriptions.
The Act contains a lengthy section discussing the new requirements for telemedicine and provides the U.S. Attorney General with the authority to issue registrations to practitioners who practice telemedicine.
There are several aspects of the Act that will need to be clarified. For example, pharmacies do not “distribute” controlled substances pursuant to a prescription so it is unclear why the Act prohibits distributing, along with delivery and dispensing, without a valid prescription. “Distribute” means “to deliver (other than by administering or dispensing) a controlled substance or listed chemical.” 21 U.S.C. § 802(11). Controlled substances are “dispensed,” not “distributed,” pursuant to a prescription. “Dispensing” is the delivery of “a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner.” 21 U.S.C. § 802(10). By prohibiting distribution without a valid prescription the Act prohibits something that should not occur.
Also, the Act would define a “valid prescription,” although historically DEA has deferred to local medical standards on these issues. Including this definition raises a number of issues. A “valid prescription” is defined as one “issued for a legitimate medical purpose in the usual course of professional practice by . . .a practitioner who has conducted at least 1 in-person medical evaluation of the patient . . . or a covering practitioner.” The regulations have long required that for controlled substance prescriptions “to be effective,” they must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. 21 C.F.R. § 1306.04(a). DEA has addressed the issue of Internet pharmacies and opined that a bona fide physician/patient relationship must exist for a doctor to issue a prescriptions in the usual course of professional practice and that the doctor must have conducted a physical examination to establish such a relationship. The Act requires an “in-person medical evaluation.” Is “an in-person medical evaluation” the same as a “physical examination?” We surmise that an “in-person medical evaluation” appears close to a “physical examination.” But conducting an “in-person medical evaluation” may involve diagnosing a patient without physically examining them, while a physical examination seems to include, at the very least, looking at the patient, listening to their heartbeat and taking their blood pressure. DEA needs to further clarify what qualifies as “in-person medical evaluation.” Secondly, the definition of “covering practitioner” appears to indicate that “an evaluation of the patient through the practice of telemedicine” is an adequate substitute for an “in person medical evaluation.”
Interestingly, a valid prescription has no time constraints during which a prescribing practitioner had to have conducted at least one in-person medical evaluation, but requires a practitioner for whom a prescriber is covering, to have conducted an evaluation within the past 24 months.
There is also no information on the type of endorsement or registration DEA will provide to pharmacies so they can dispense via the Internet. And while endorsement requests will assist DEA in determining the legitimate pharmacies, how will DEA keep those lacking endorsements from dispensing over the Internet, especially if they lack a permanent physical address? The endorsement and notification requirements will help ensure a pharmacy’s legitimacy by providing DEA with a physical address, but in order for the Act to be effective, DEA must prevent patients from ordering from pharmacies that have not met the Act’s requirements.
By John A. Gilbert and Larry K. Houck