Tuesday, December 2, 2014

Kentucky Board of Pharmacy Provides Suggestions on Compliance

Compliance Corner: Are You in Compliance?
Submitted by Phil Losch, RPh, Pharmacy and Drug Inspector
of the Board
Is your Drug Enforcement Administration (DEA) Combat Methamphetamine
Epidemic Act of 2005 (CMEA) Self-Certification of
Regulated Sellers of Scheduled Listed Chemical Products (SLCPs)
up to date?
As part of the requirements for CMEA, an annual self-certification
is required for all regulated sellers of SLCPs (ie, ephedrine,
pseudoephedrine, and phenylpropanolamine). A regulated seller
must not sell SLCPs unless he or she has self-certified with DEA.
In self-certifying, the regulated seller is confirming:
♦ Employees have been trained,
♦ Records of the training are being maintained,
♦ Sales limits are being enforced,
♦ Products are being stored behind the counter or in a locked
cabinet, and
♦ A written or electronic logbook is being maintained.
The only way to self-certify (recertify) is through the Internet on
the Diversion Control Program website located at www.deadiversion
.usdoj.gov. Once you are on the website, click on “CMEA (Combat
Meth Epidemic Act),” and then click on “Self-Certification” under
the CMEA Required Training & Self-Certification section. Once
certified, you will be able to print your certificate of compliance
that can be posted in your pharmacy. Remember, this is an annual
requirement, not a one-time event.
It has been noticed recently during routine inspections of retail
pharmacies that many certificates that are posted have expired.
It is essential that if you are a retail seller of pseudoephedrine or
ephedrine, you have an active CMEA certificate for your pharmacy
that is up to date.

quoted from Kentucky Board of Pharmacy 2014 Newsletter

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