Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine
The Combat Methamphetamine Epidemic Act of 2005 has been incorporated into the Patriot Act signed by President Bush on March 9, 2006. The act bans over-the-counter sales of cold medicines that contain the ingredient pseudoephedrine, which is commonly used to make methamphetamine. The sale of cold medicine containing pseudoephedrine is limited to behind the counter. The amount of pseudoephedrine that an individual can purchase each month is limited and individuals are required to present photo identification to purchase products containing pseudoephedrine. In addition, stores are required to keep personal information about purchasers for at least two years.
What is FDA announcing today?
The FDA is announcing new legal requirements for the legal sale and purchase of drug products containing pseudoephedrine, ephedrine, and phenylpropanolamine required by the Combat Methamphetamine Epidemic Act of 2005. This new law 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.
What is The Combat Methamphetamine Epidemic Act of 2005?
The Combat Methamphetamine Epidemic Act of 2005 has been included in the Patriot Bill signed by the President on March 9, 2006. The Act would ban over-the-counter sales of cold medicines that contain ingredients that are commonly used to make methamphetamine such as pseudoephedrine.
Who has responsibility for enforcement of the Act?
The Drug Enforcement Administration (DEA).
What is pseudoephedrine?
Pseudoephedrine is a drug found in both prescription and over-the-counter products used to relieve nasal or sinus congestion caused by the common cold, sinusitis, hay fever, and other respiratory allergies. It can also be used illegally to produce methamphetamine.
What is methamphetamine?
Methamphetamine is a powerful, highly addictive stimulant. It is manufactured in covert, illegal laboratories throughout the United States. Methamphetamine can be ingested by swallowing, inhaling, injecting or smoking. The side effects, which arise from the use and abuse of methamphetamine, include irritability, nervousness, insomnia, nausea, depression, and brain damage.
Does this mean I need a prescription from my doctor to buy pseudoephedrine?
No. The Act allows for the sale of pseudoephedrine only from locked cabinets or behind the counter. The law:
- limits the monthly amount any individual could purchase
- requires individuals to present photo identification to purchase such medications
- requires retailers to keep personal information about these customers for at least two years after the purchase of these medicines.
When will this law take effect?
This law becomes effective September 30, 2006.
Does the requirements of this law affect combination products, or just products that contain pure pseudoephedrine?
The requirements of this law will affect all products that contain ingredients pseudoephedrine, phenylpropanolamine, and ephedrine.
I still see Sudafed PE on the shelves. Is this different from regular Sudafed?
Yes, Sudafed PE is different from Sudafed. Sudafed contains the active ingredient Pseudoephedrine, while the active ingredient in Sudafed PE is Phenylephrine. In response to the issue of misuse of pseudoephedrine-containing products, many companies are voluntarily re-formulating their products to exclude phenylpropanolamine, ephedrine, and pseudoephedrine.
What are all the products that include the ingredients affected by this new law?
The FDA recommends that consumers read the labels of OTC drug products to determine if the product contains pseudoephedrine, ephedrine, or phenylpropanolamine. FDA believes this to be the most accurate method for determining the contents of OTC products rather than providing an incomplete or out-of-date list of products that may have already been reformulated and no longer contain these ingredients.
Products containing pseudoephedrine are already considered prescription controlled substances in my state. Does this new law change that status?
In response to the misuse of methamphetamine, many state governments have issued regulations controlling the sale of these products. This should not effect the restrictions already placed in your state.
I have chronic sinus problems. Will I be limited from getting the amount of pseudoephedrine I need?
Yes, with this new law there will be limits on the number of tablets of ephedrine, pseudoephedrine, or phenylpropanolamine that can be purchased in a 30-day period. As there are many different dosages and formulations of these products, you should ask your pharmacist how much you will be allowed to purchase over a 30-day period for specific product you use.
How will this change the way pseudoephedrine is sold?
The Act requires that each regulated seller ensure that:
- Customers do not have direct access to the product before the sale is made.
- A written or electronic “logbook” listing sales is kept that identifies the products by name, quantity sold, names and addresses of purchasers, and the dates and times of the sales.
- There is a limit on the amount that can be purchased in a single day and in a month.
What does “behind-the-counter” mean?
The Act defines “behind-the-counter” as placement of the product to ensure that customers do not have direct access to the product before the sale is made. In other words, placement may be in a secure location in the pharmacy prescription-filling area or in a locked cabinet that is located in the area of the facility to which customers do not have direct access. In all cases, the seller will deliver the product directly into the custody of the buyer.
Will training be required for personnel responsible for selling pseudoephedrine ?
Companies selling products containing pseudoephedrine are required to submit to the Attorney General a statement regarding self-certification and training on the new law.
What about a sample size package containing only 1-2 pills of pseudoephedrine like those often sold at gas stations or grocery stores?
The Act exempts the requirements of a “logbook” to any purchase by an individual of a single sales package if that package contains not more than 60 milligrams of pseudoephedrine. These single dose packages have to remain behind the counter.
What will be required to purchase pseudoephedrine?
In order to purchase pseudoephedrine
- Present a photo identification card issued by the State or the Federal Government or a document that is considered acceptable by the seller
- Enter into the logbook their information such as name, address, date and time of sale, and signature
- Verify the logbook entries, and enter in the name of the product and quantity sold
What if I have other questions about pseudoephedrine or this new law?
If you have further questions regarding pseudoephedrine, phenylpropanolamine, ephedrine, or any medications, please contact the Division of Drug Information in the FDA’s Center for Drug Evaluation and Research (CDER) at: 888-INFOFDA (888-463-6332), or email us at: email@example.com