Courtesy of Erik Lieberman, National Grocers Association
On September 30, 2006 the second phase of the Combat Methamphetamine Epidemic Act (CMEA) goes into effect and will require all pseudoephedrine (PSE)-containing products** regardless of form—including liquid, liquid-filled gel capsules and pediatrics—to be pulled from the shelves and placed behind a counter or in a locked display case.
Also on September 30th, retailers will be required to maintain a paper or electronic log of each transaction involving over-the-counter (OTC) sales of PSE products. Retailers intending to sell PSE products are required by CMEA to submit a “self-certification” to the Drug Enforcement Administration (DEA). The self-certification will include a statement by the retailer that it understands and agrees to abide by the requirements of CMEA and ensures that employees selling PSE products to consumers have been trained accordingly. A self-certification must be filed by each individual retailer location selling PSE products. CMEA mandates that self-certifications be filed by September 30, 2006; however, as of the date of this Action Alert, DEA has yet to establish such a system. DEA has stated that a system will be in place on-line within the next couple of weeks whereby retailers may submit the self-certifications.
As a reminder, CMEA is phased-in in two steps.
The first phase impacting retail sales went into effect on April 8, 2006 and contains only two restrictions —
- retailers are prohibited from selling a consumer more than 3.6 grams of PSE base in a given day; and
- consumers are prohibited from purchasing more than 9 grams of PSE base per 30 day period.
The second phase requires:
- all PSE products be placed behind the counter or in a locked display case;
- a log to be kept of each transaction; and
- a self-certification to be filed with DEA for each individual retail location selling PSE products.
State laws exceeding the federal restrictions are not preempted by CMEA (e.g. Schedule V); however, state and local laws that are less restrictive than CMEA are preempted (e.g. liquid and liquid-filled gel capsule exemptions).
**All of the restrictions apply to ephedrine (EPH)-containing products (e.g. Primatene® Tablets) as well. Phenylpropanolamine (PPA)-containing products are also restricted by CMEA but were deemed unsafe for human use by FDA in 2000. PPA is not found in U.S. OTC products. Phenylpropanolamine is still found in veterinary prescription drugs (Proin™, Cystolamine®) sold in the U.S. **
The Combat Methamphetamine Epidemic Act of 2006
The Combat Methamphetamine Epidemic Act of 2006 (CMEA), an amendment to the US Patriot Act, was made law on March 9, 2006. The new law assigned the description of scheduled listed chemical product (SLCP) to any non-prescription medication that contains ephedrine, pseudoephedrine (PSE) or phenylpropanolamine. The law limits the quantity of all forms of product (as base) sold at retail and may not exceed for any purchaser a total of 3.6 grams dailyor 9 grams during a thirty day period. No more than 7.5 grams of product, as base, may be imported by means of shipping via private or commercial carrier or the USPS as a part of that 30 day maximum. These limits are intended for the consumer and not for the retailer to enforce.
However, a retailer – pharmacy or other retailer - may not act recklessly in selling these products. All non-liquid products must be sold in blister packs, not to contain more than 2 dosage units per package. These purchase limits went into effect on April 8, 2006. All other provisions of the law will become effective September 30, 2006.
All SLCPs offered for retail sale must not available for direct access by the consumer before the sale. The law recommends a behind-the-counter placement of these products which also includes circumstances in which the products may be stored in a locked cabinet in the facility; again, preventing direct customer access.
All sellers are to maintain a written or electronic list of sales of SLCPs. The law refers to this list as a logbook. This logbook is to be used to record each sale and the following information is required to be documented: identity of each product sold, by name; the quantity sold; the name and address of each purchaser, and; the date and time of the sale. Every prospective purchaser must present a valid identification card with photo, or an acceptable document issued by a State or Federal Government, and sign the log book. Any misrepresentation by thePurchaser will be subject to criminal penalties under the Act; a misrepresentation notice, including penalties, must be in the logbook available for review by the purchaser at the time of sale. The logbook must be maintained for not fewer than 2 years. These requirements do not apply to any purchase of a single sales package that contains not more that 60 mg of PSE.
The specific criteria for the logbook will be forthcoming from the Drug Enforcement Administration (DEA), Department of Justice.
Each seller must provide to the DEA a self-certification that all individuals delivering products to purchasers or obtaining payments from purchasers have undergone training that ensures that the requirements of this Act are understood. The seller must maintain records of such training at each place of business where such products are sold. A separate certification is required for each place of business. The DEA is planning to develop an Internet-based certification program for all regulated sellers. Once the DEA has received notice of certification from the seller, the information will be passed on to the appropriate State and local officials.
In addition, a regulated seller may take reasonable measures to guard against employing individuals who present a risk to theft and diversion of SLCP, which may included asking employment applicants whether they have been convicted of any crime involving or related to such products or controlled substances.
Information contained in the logbooks is private and it will only be disclosed as appropriate to the DEA or in good faith to State and local law enforcement agencies. A violation of the law will occur for any seller who refuses to provide sales logbook information to law enforcement authorities. The DEA will develop additional regulations to ensure that the information in the logbook is not used for any other purposes, but to ensure compliance with this law or to facilitatea product recall for the purpose of public health and safety.
Mail order retailers are not immune to the law. The DEA will establish procedures through regulations for sellers to confirm the identity of the purchaser prior to the shipping of the product.
As mentioned earlier, there will be a 30 day limit of 7.5 grams of SLCP base that can be sold to a customer by the mail order seller.
The DEA also has the authority to exempt a chemical from the scheduled list of chemical products through regulation if it can be determined that the product cannot be used in the illicit manufacture of methamphetamine.
The penalties for violation of the law include a civil penalty of up to $25,000; and, if committed knowingly, imprisonment of up to one year in addition to a fine to be determined by existing federal crime laws; or, if committed after a prior conviction for a violation of the Controlled Substances Act, then imprisonment of up to two years in addition to a fine to be determined by existing federal criminal laws. In addition, if a regulated seller or distributor sells at retail a SLCP in violation of this Act, or knowingly and recklessly sells a product in violation, or discloses information from the logbook in violation of the Act, the DEA may by order prohibit such seller or distributor from selling any SLCP.