Regulatory Compliance Management Information
Table of Contents
I. In a Nutshell: What is the Combat Methamphetamine Epidemic Act of 2005?
II. Why does the Combat Methamphetamine Act of 2005 exist?
III. The Details: Combat Methamphetamine Epidemic Act of 2005 Requirements & Compliance
IV: How does the Combat Methamphetamine Epidemic Act of 2005 affect your business?
V: Combat Methamphetamine Epidemic Act of 2005 Information Resources
The Combat Methamphetamine Epidemic Act of 2005, or CMEA for short, details the federal regulation of the retail of chemicals that are used to make methamphetamine. The act went into effect on March 9, 2006 as part of Title VII of the USA Patriot Improvement and Reauthorization Act of 2005 (i.e., the Patriot Act). CMEA is also commonly referred to as the Methamphetamine Epidemic Elimination Act.
Methamphetamine, or meth for short, arguably is the biggest source of drug-related issues in this country. It is a powerful stimulant, and as Schedule II controlled substance, it is illegal to sell or consume meth except under a narrow window of accepted medical purposes. A recent National Association of Counties Survey found that law enforcement officials reported meth is the biggest drug problem in their counties, more so than any other drug, such as cocaine or heroin.
Methamphetamine has an incredibly high potential for abuse and addiction – in 2011 alone, 102,961 emergency room visits were methamphetamine-related.
In addition, methamphetamine production is quite harmful to the environment and can be extremely dangerous to the surrounding community: highly flammable and explosive materials and chemicals are needed to produce meth, with 5-7 pounds of toxic waste byproduct created for every 1 pound of meth produced.
In order to produce meth, at least one of the following compounds is needed: ephedrine, pseudoephedrine, or phenylpropanolamine. These compounds are considered ‘precursors’ to meth – to put it very simply, when chemically combined with other compounds, these compounds produce meth.
*Note: The FDA has ordered the removal of phenylpropanolamine from all drugs in the United States, and as such, it is no longer available for retail or consumption due to its side effect of increasing the risk of stroke in younger women*
Ephedrine and pseudoephedrine are compounds commonly used as active ingredients in cough, cold, and allergy medicines and products, which is why they are available for retail and consumption, even without a prescription, despite their propensity to be used in the manufacture of meth.
The rationale is that if you regulate the sale of these products, the manufacture of methamphetamine can be prevented, or at least, greatly decreased.
The CMEA covers the following:
Under the CMEA, a ‘scheduled listed chemical product’ is one that:
The salts, optical isomers, and salts of optical isomers of ephedrine, pseudoephedrine, and phenylpropanolamine are all considered a ‘scheduled listed chemical product’ under CMEA regulations.
Although products with ephedrine and pseudoephedrine are regulated, it does not mean a customer needs a prescription to purchase such products. Rather than requiring a prescription for all products containing those compounds, CMEA regulations restrict the public’s accessibility of these products prior to the point-of-sale. To be clear, there are indeed some products with either ephedrine or pseudoephedrine that require a prescription.
CMEA compliance requires that scheduled listed chemical products need to either be:
The following is an overview of the steps a seller needs to take at the point-of-sale of a scheduled listed chemical product.
Anytime a non-prescription sale of more than 60mg of ephedrine/pseudoephedrine occurs, an entry in either a written or electronic logbook needs to be made, detailing the sale. These entries need to include:
The logbook is required to give notice to buyers that providing false or misleading information for the logbook can subject the buyer criminal penalties that carry a maximum fine of $250,000 and a maximum 5-year term of imprisonment.
Once the entry has been made, the seller needs to verify the buyer’s proof of identity by matching the name entered in the logbook to the name on the proof of identity. Under CMEA regulations, an acceptable proof of identity is a photographic identification card issued by the State or the Federal government.
Purchases via mail-order are subjected to the same proof of identity requirements before shipping the products to the buyer.
If a customer has a prescription for a product that contains ephedrine/pseudoephedrine, no logbook entry needs to be made, even if the product contains more than 60mg of ephedrine/pseudoephedrine.
Regardless of purchase amount, any suspicious transaction needs to be entered into the logbook in the event law enforcement needs the details of a transaction in question.
In addition, a report to the Attorney General needs to be given any time:
The following is an overview of the quantitative CMEA regulations.
If a scheduled listed chemical product is a non-liquid, it can only be sold in a 2-unit dose blister pack
CMEA regulations affect any entity or person whose activities as a distributor relating to the above-mentioned scheduled listed chemical products are limited almost exclusively to sales for personal use, both in number of sales and volume of sales. For example, a grocery store that sells the scheduled listed chemical products needs to comply with CMEA regulations in the same way that a pharmacy needs to.
In other words, if your business has nothing to do with the sale of products that contain ephedrine or pseudoephedrine - at least for personal use – then you do not need to worry about complying with CMEA regulations as they don’t pertain to your business.
To make sure that all employees of the entity know CMEA regulation compliance procedures, such as the logbook requirements and customer purchase limits, every entity is required to provide training for and self-certify each employee about CMEA regulations.
Training and self-compliance is to be done and reported online via the CMEA Required Training & Self-Certification program, which is run by the Department of Justice (USDOJ) and the Drug Enforcement Administration (DEA).
Although the vast majority of CMEA rules and compliance procedures have been discussed here, there are CMEA details that are too nuanced to effectively cover here.
Any business that sells or is planning on selling products with ephedrine or pseudoephedrine needs to make sure that their employees are trained and have reported self-compliance to the Department of Justice (USDOJ) and the Drug Enforcement Administration (DEA) before selling such products.
Businesses can find training materials for their employees and report self-compliance by clicking here.
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