October 11, 2006
BAN ON OVER—THE—COUNTER SALES OF DRUG PRODUCTS CONTAINING PSEUDOEPHEDRINE
By: John Kasprak, Senior Attorney
You asked for information on a recent federal law that bans the over-the-counter sale of drug products that contain ingredients that can be used to make methamphetamine.
The Combat Methamphetamine Epidemic Act of 2005 was incorporated into the Patriot Act signed by President Bush on March 9, 2006. The act bans the over-the-counter sales of cold medicines that contain pseudoephedrine, ephedrine, and phenylpropanolamine. These ingredients are commonly used to make methamphetamine.
Beginning September 30, 2006, the act limits the sale of drug products containing these ingredients to behind the counter. It also limits the amount of medicine containing these ingredients that an individual can buy each month and requires purchasers to present photo identification in order to purchase it. Also, stores must keep personal information about purchasers for at least two years.
FEDERAL LAW REQUIREMENTS
The new federal law, which took effect September 30, 2006, calls for a comprehensive system of controls regarding the distribution and sale of drug products that can be used in the illicit production of methamphetamine. The federal Drug Enforcement Agency (DEA) enforces the act. The act bans over-the-counter (OTC) sales of cold medicines that contain the ingredients pseudoephedrine, ephedrine, and phenylpropanolamine.
Pseudoephedrine is a drug found in both prescription and OTC products used to relieve nasal or sinus congestion caused by the common cold, sinusitis, hay fever, and other respiratory allergies. Ephedrine is similar in structure to the synthetic derivatives amphetamine and methamphetamine. It is commonly used as a stimulant, appetite suppressant, concentration aid, and decongestant. Phenylpropanolamine is an ingredient used in prescription and OTC drug products as a nasal decongestant and in OTC weight control drug products.
Methamphetamine is a powerful, highly addictive stimulant that is manufactured in covert, illegal laboratories throughout the United States. It can be ingested by swallowing, inhaling, injecting, or smoking. A methamphetamine fact sheet from the DEA is available at http://www.usdoj.gov/dea/pubs/pressrel/methfact01.html.
Legal Sale of Products Containing Pseudoephedrine
The federal law allows for the sale of pseudoephedrine only from locked cabinets or behind the counter. Specifically, the law:
1. limits the monthly amount any individual can purchase in a 30- day period,
2. requires individuals to present photo identification to purchase the medications, and
3. requires retailers to keep personal information about these customers for at least two years after the purchase of these medicines.
The new law, as noted above, limits the amount of ephedrine, pseudoephedrine, or phenylpropanolamine that can be bought in a 30-day period. As there are many dosages and formulations of these products, the federal Food and Drug Administration (FDA) recommends asking the pharmacist how much of the specific product in question you will be allowed to purchase over a 30-day period.
The seller of these products must maintain a written or electronic logbook that identifies the products by name, quantity sold, names and addresses of the purchaser, and the dates and times of the sales. The act exempts the requirement of a logbook to any purchase by an individual of a single sales package that contains not more than 60 milligrams (1-2 pills) of pseudoephedrine. But these single dose packages have to remain behind the counter.
Training of Personnel Selling These Products
Retail staff must be trained about the federal law. Companies selling products containing pseudoephedrine must self-certify to the U.S. Attorney General that their sales personnel have been trained on the new law as required by regulations (which have yet to be promulgated).