Combat Methamphetamine Epidemic Act (March 2017)
Pseudoephedrine is an over-the-counter (OTC) drug used to relieve nasal or sinus congestion caused by the common cold, sinusitis, and respiratory allergies. It can also be used illegally to produce methamphetamine - a powerful, highly addictive stimulant. FDA Drug Info Rounds pharmacists focus on the legal requirements for the sale of OTC drug products that contain pseudoephedrine.
Host: Captain Catherine Chew
Pharmacist: Dr. Renu Lal
CAPT Chew: Administered by the Drug Enforcement Administration, the Combat Methamphetamine Epidemic Act of 2005, also known as the CMEA, sets legal requirements for the sale and purchase of certain nonprescription drug products. Today, we’ll focus on the legal requirements for drug products that contain pseudoephedrine.
Hi, I’m Captain Catherine Chew, and this is Drug Info Rounds, brought to you by the pharmacists in FDA’s Division of Drug Information.
Pseudoephedrine is an over-the-counter drug used to relieve nasal or sinus congestion caused by the common cold, sinusitis, and respiratory allergies. It can also be used illegally to produce methamphetamine - a powerful, highly addictive stimulant. I’m joined by Dr. Renu Lal who will review some of the legal requirements of the CMEA.
Dr. Lal: The CMEA sets the daily sales limit and the 30-day purchase limit for pseudoephedrine products. The daily sales limit is 3.6 grams of pseudoephedrine. The 30-day purchase limit is 9 grams of pseudoephedrine. The limits apply to each customer.
These products must be sold from locked cabinets or behind the counter, and at the time of purchase, customers are required to present photo identification. Stores are generally required to maintain a logbook, which must be signed by the purchaser and must include:
- the product name
- quantity sold
- name and address of purchaser
- and the date and time of the sale.
This information must be kept for at least two years after the purchase.
Some states may have additional restrictions that apply to the sale and purchase of pseudoephedrine, such as requiring sellers to be pharmacists or pharmacy technicians. State Boards of Pharmacy may be able to provide information regarding what the individual requirements are in your state on the sale and purchase of pseudoephedrine-containing products. You can locate your State Board of Pharmacy’s contact information online.
Some states use a real-time electronic logging system called the National Precursor Log Exchange, or NPLEx. The NPLEx system allows pharmacies and law enforcement to track sales of over-the-counter cold and allergy medications that contain pseudoephedrine. To learn if NPLEx is used by your state, please visit www.nplexservice.com.
CAPT Chew: The CMEA was enacted in an effort to combat illicit methamphetamine production while still permitting continued patient access to pseudoephedrine for legitimate medical purposes.
If you have questions about the sale and purchase of pseudoephedrine-containing products, call or email FDA’s Division of Drug Information.