When preparing for a pharmacy inspection, most facilities focus on controlled substance records, DEA documentation, inventory counts, and prescription files. However, one compliance item that is frequently overlooked is the Combat Methamphetamine Epidemic Act (CMEA) self-certification.
Although it may not receive the same attention as DEA registration, an expired or missing CMEA certificate can quickly become a finding during an inspection. Taking a few minutes to verify that your certification is current can help prevent unnecessary compliance issues.
What Is the CMEA?
The Combat Methamphetamine Epidemic Act of 2005 (CMEA) was enacted to reduce the diversion of over-the-counter products containing pseudoephedrine, ephedrine, and phenylpropanolamine for the illicit manufacture of methamphetamine.
https://www.deadiversion.usdoj.gov/meth/combat-methamphetamine-epidemic-act.html
Retail sellers, including pharmacies, that sell these scheduled listed chemical products must comply with federal requirements governing:
- Employee training
- Self-certification with the DEA
- Product placement and security
- Customer purchase limits
- Identification verification
- Sales logbook requirements
The DEA Self-Certification Requirement
Before selling scheduled listed chemical products, retailers must complete DEA self-certification. This certification confirms that the business has trained employees and has procedures in place to comply with the CMEA requirements.
The certificate should be maintained with your compliance records and be readily available if requested during an inspection.
One of the most common issues identified during inspections is that the pharmacy completed self-certification years ago but failed to renew it.
Veterinary practices are effectively exempt from the CMEA self-certification requirement.
Renewal
DEA self-certification must be renewed annually. Renewal is completed electronically through the DEA Diversion Control Division’s website.
Even if nothing has changed at your pharmacy, the certification does not remain valid indefinitely. Allowing it to expire can place your pharmacy out of compliance.
Many pharmacies find it helpful to add the renewal date to their compliance calendar so it is reviewed each year alongside DEA registration renewals and other regulatory deadlines.
Don’t Forget Employee Training
Federal regulations also require that employees involved in the sale of scheduled listed chemical products receive appropriate training regarding the CMEA requirements.
Training should cover topics such as:
- Daily and 30-day purchase limits
- Identification verification requirements
- Proper completion of sales logbooks
- Recognizing prohibited sales
- Record retention requirements
Training should be documented and retained as part of your compliance program. If it isn’t documented, it never happened.
Record-Keeping
Pharmacies selling pseudoephedrine and other scheduled listed chemical products must also comply with federal record-keeping requirements. Depending on the product and method of sale, requirements may include:
- Electronic or written sales logbooks
- Purchaser identification information
- Purchaser signatures (when applicable under current requirements)
- Documentation demonstrating compliance with daily and monthly purchase limits
- Retention of required records for the applicable federal retention period
Many pharmacies rely on electronic systems to manage these requirements, but it remains the pharmacy’s responsibility to ensure records are complete and readily retrievable during an inspection.
A Simple Compliance Check
During your next internal compliance review, ask yourself:
Is our DEA CMEA self-certification current?
Can we quickly locate our certificate?
Have employees received documented CMEA training?
Are our pseudoephedrine sales records complete and readily available?
Are we following the current federal purchase limit and identification requirements?
The CMEA certificate is a relatively simple compliance requirement, but because it is only renewed once each year, it is easy to overlook. Unfortunately, inspectors often do not overlook it.
Taking a few minutes to verify that your self-certification is current, your staff training is documented, and your records are complete can help ensure your pharmacy remains compliant and inspection-ready.
Like many areas of regulatory compliance, success often comes from paying attention to the small details before an inspector has to point them out.