Pharmacy Law CE Column

By Laura Carpenter, RPh, JD, attorney and pharmacist, founder Carpenter Law Firm, PLLC

Pseudoephedrine sale & reporting laws

Methamphetamine is a highly addictive, synthetically produced central nervous system stimulant with effects similar to cocaine. According to the U.S. Drug Enforcement Administration, meth is the most prevalent synthetic drug manufactured in the United States because it is easily produced in clandestine laboratories using such common products as pseudoephedrine, ephedrine, camping fuel, iodine, rock salt, battery acid, pool acid and such common kitchen items as plastic bags, glass cookware and funnels.

Methamphetamine addiction typically occurs when a person begins to use the drug as a stimulant, for its powerful enhancing effects on sex, mood and energy, alertness and ability to concentrate, and weight loss and appetite suppression, among its other psychological and physical effects. Over time, tolerance develops, and users have greater difficulty functioning and experiencing pleasure than they did before, which persists indefinitely due to neurotoxicity produced by methamphetamine in long-term recovered addicts. Nicknames for methamphetamine are numerous and vary significantly from region to region---some common nicknames for methamphetamine include "speed", "jib", "crank", "meth", "ice", "crystal", "glass" and "chalk."

Until a few years ago, pseudoephedrine was an over the counter drug. However, because of the common practice of using pseudoephedrine to manufacture meth ¹, there has been a push to regulate pseudoephedrine more thoroughly. Beginning with the Combat Methamphetamine Epidemic Act of 2005 (Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005, P.L. 109-177),² Congress changed pseudoephedrine and ephedrine's status from over-the-counter to that of a scheduled listed chemical product.

If you have worked in community pharmacy since 2006, you should be very familiar with these changes because the Act requires every seller of pseudoephedrine products to train all of its employees.³ Still, a refresher is always in order. In brief, the Act requires:

1. All pseudoephedrine-containing products must be kept behind the counter or in a locked cabinet.
2. Individuals may not purchase more than 3.6 grams of pseudoephedrine in one day.
3. Individuals may not purchase more than 9.0 grams of pseudoephedrine in any 30-day period (or, if purchased from a mail order pharmacy or a "mobile vendor," no more than 7.5 grams in any 30-day period).
4. The purchaser must present a state or federal government issued photo identification card at the time of purchase.
5. Either a written or electronic logbook of all pseudoephedrine transactions must be kept by the pharmacy for a period not less than two years from the date of purchase.
6. For each sale, information including the name and address of the purchaser, the name of the product, the quantity purchased, and the date and time of the transaction must be collected and entered into the logbook.
7. Products packaged for individual sale that contain less than 60 milligrams of pseudoephedrine are exempt from the logbook requirements but must also be kept behind the counter.
8. The person selling the pseudoephedrine must confirm the information provided by the purchaser matches that provided on the identification card.
9. The purchaser must provide a signature verifying the information provided is correct.

In addition to the federal law, nearly all the states have passed or are pursuing legislation. State laws vary considerably. Some parts of a state law may be less stringent than the federal requirements; other parts may be more stringent. The Combat Meth Epidemic Act does not preempt those requirements under state laws that are more stringent than the Act's requirements. Therefore, you must comply with the most stringent requirements.

Oregon is currently the only state that requires a prescription for pseudoephedrine products. Other states classify it as a Schedule V controlled substance, which must be kept behind the pharmacy counter and sold by a pharmacist.

Some of these differences are listed below (this list is not all-inclusive, it is important to know the requirements in the state in which you practice):

1. California - Makes possession of pseudoephedrine with the intent to manufacture meth illegal; limits amount that can be purchased legally;
2. Florida - Requires sellers of pseudoephedrine to keep product behind a counter; limits amount that can be purchased legally;
3. Georgia - Requires sellers of pseudoephedrine to keep product behind a counter; limits amount that can be purchased legally; requires that product be sold in blister packaging;
4. Illinois - Requires purchasers to show valid ID and sign log;
5. Louisiana - Enacted a new law establishing a real-time pseudoephedrine reporting system once a federal grant is secured;
6. Michigan - Requires product to be kept behind counter or in locked case, requires purchasers to provide ID and sign log;
7. New Jersey - Limits amount that can be purchased legally;
8. Ohio - Restricts amount of pseudoephedrine that can be purchased legally; bans sale to minors;
9. Oklahoma - Classifies pseudoephedrine as a Schedule V drug under state law, requires purchasers to present ID and sign log; limits amount which can be purchased legally;
10. Oregon - Classifies pseudoephedrine as a Schedule III drug under state law, makes possession of more than 300 tablets a crime;
11. Texas - Encourages voluntary action by retailers to reduce illegal sales, such as by limiting quantity that can be purchased or taking measures to prevent theft of pseudoephedrine;
12. Virginia - Requires product to be kept behind counter or in locked case, requires purchasers to provide ID and sign log; limits amount that can be purchased legally.

States have begun to require electronic reporting of pseudoephedrine products. In addition to letting the pharmacist know whether a customer may purchase pseudoephedrine, these electronic databases are extremely helpful to law enforcement officers. States that have instituted electronic reporting systems have been shown to dramatically reduce the rate of illicit manufacture of meth.

Taking it one step further, Kentucky and Indiana have announced in March 2009 that they are entering into a pilot partnership to expand Kentucky's MethCheck electronic pseudoephedrine monitoring system to deter individuals from crossing state lines to purchase the main ingredient in meth.⁴ State and local law enforcement agencies will work with border counties to adopt local ordinances requiring the sale of pseudoephedrine be handled by a pharmacist and allow these counties to participate in the MethCheck program free of charge for one year. This pilot program marks the first time that the two states have shared electronic pseudoephedrine purchase information on a real-time basis.

It is likely that states will continue to change the requirements for pseudoephedrine sales reporting. As the laws continue to unfold, pharmacists should keep abreast of developments and seize all opportunities to help patients achieve their self-care goals. Contact your state pharmacy association or board of pharmacy to learn the specifics of methamphetamine control measures in your state. It is also important to follow any company specific policies and procedures regarding pseudoephedrine sales.

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