New Rules Implement Ryan Haight Act

Sixty-day public comment period for new regulations designed to make prescriptions filled online safer began Monday.

by / April 15, 2009

Photo: Ryan Haight died at 18 of a drug overdose in 2001 after he procured Vicodin over the Internet.

New Drug Enforcement Administration (DEA) regulations implementing the Ryan Haight Act went into effect on April 13th. The Interim Final Rule was published in the Federal Register this week, and the public has 60 days from its publication to submit comments to the DEA.

The Ryan Haight Act was named for an 18-year-old who died after overdosing on a prescription painkiller he obtained on the Internet from a medical doctor he never saw. After his death, Haight's story became a rallying point for relatives of others who had died from prescription drug overdoses to encourage the passage of the legislation that bears his name.

Like Haight, nearly one in five teenagers has used a prescription medication to get high, according to the 2008 Partnership Attitude Tracking Survey (PATS) conducted by the Partnership for a Drug-Free America. The same survey found that two in five teens believe the fallacy that prescription medicines obtained without a prescription are "much safer" to use than illegal drugs. The 2008 Monitoring the Future survey sponsored by the National Institute on Drug Abuse found that 7 of the top 10 drugs abused by high school seniors are prescription or over-the-counter medications. Prescription drugs are now as common as marijuana as the gateway to recreational drug use and abuse by teenagers.

Unscrupulous or "rogue" Internet pharmacies exist to profit from the sale of controlled prescription medicines to buyers who have not seen a doctor and don't have a prescription from a registered physician. The pharmacies lack quality assurance and accountability, and their products pose a danger to buyers. They pretend to be authentic by operating websites that advertise powerful drugs with the "approval" of a "doctor" working for the drug trafficking network. Prescription medications are powerful drugs that, while lifesaving under some circumstances, can be harmful or even lethal under others, and registered physicians and pharmacists exist to advise consumers on the difference. DEA maintains a hotline for reporting suspicious Internet pharmacies.

"Now that this law has been put into force it will be harder for cyber-criminals to supply controlled substances over the Internet and easier for us to prosecute them," said DEA Acting Administrator Michele M. Leonhart. "These regulations add important new provisions to prevent the illegal distribution of controlled substances through the Internet. Its implementation will increase Internet safety and help prevent tragedies like Ryan Haight's death from happening again."

The statute amends the Controlled Substances Act (CSA) by adding several new provisions to prevent the illegal distribution of controlled substances by means of the Internet. The rules would require at least one face-to-face medical evaluation before a patient could receive a prescription for a controlled substance over the Internet.

The new rules also place tougher restrictions on online pharmacies. The rules create new definitions of what classifies as an online pharmacy and what it means to deliver, distribute or dispense meds by means of the Internet.

Rather than try to block all online pharmaceutical sales, the rules called for by the Ryan Haight Act put online pharmaceutical sales on an equal regulatory footing with sales made through a brick-and-mortar facility. The rules require an endorsement of an existing registration to allow existing pharmacies to sell controlled substances online. This means law enforcement will be able to carefully scrutinize all applications for such registration and be able to easily separate legitimate and illegitimate Internet operations. The rules also set prescription reporting requirements for online pharmacies.

Consistent with the CSA itself, the Ryan Haight Act relates solely to controlled substances. Controlled substances are those psychoactive drugs and other substances - including narcotics, stimulants, depressants, hallucinogens, and anabolic steroids -- that are placed in one of the five schedules of the CSA due to their potential for abuse and likelihood that they may cause psychological or physical dependence when abused. Controlled substances constitute only a small percentage of all pharmaceutical drugs. Approximately 10 percent of all drug prescriptions written in the United States are for controlled substances, with the remaining approximately 90 percent of prescriptions being written for non-controlled substances. The amendments to the CSA made by the Ryan Haight Act, as well as the regulations being issued here, do not apply to non-controlled substances.