Federal law now requires any retailer selling ephedrine or pseudoephedrine
products to meet standard guidelines. The following information is
from the Drug Enforcement Agency's website to help managers understand
what they need to do and how to self-certify in order to legally sell
these products.
Compliance for Regulated Sellers
Q. As a retailer, what must I do in order
to continue to sell products containing ephedrine, pseudoephedrine, or
phenylpropanolamine?
A. On and after September 30, 2006,
retailers, or regulated sellers, must be "self-certified" before selling
these products and must comply with all provisions of the CMEA relating
to employee training, product placement, photo identification of
customers, sales logbooks, and other procedures listed in the law. DEA
has provided detailed training instructions for use in explaining your
obligations on its
website.
Q. What is a regulated seller?
A. A regulated seller is a retail
distributor or mobile retail vendor. The term "retail distributor" means
a grocery store, general merchandise store, drug store, or other entity
or person whose activities as a distributor relating to drug products
containing pseudoephedrine or phenylpropanolamine are limited almost
exclusively to sales for personal use, both in number of sales and
volume of sales, either directly to walk-in customers or in face-to-face
transactions by direct sales. Also for the purposes of this paragraph, a
grocery store is an entity within Standard Industrial Classification
(SIC) code 5411, a general merchandise store is an entity within SIC
codes 5300 through 5399 and 5499, and a drug store is an entity within
SIC code 5912.
The term "mobile retail vendor" means is a person or entity that makes
sales at retail from a stand that is intended to be temporary, or is
capable of being moved from one location to another, whether the stand
is located within or on the premises of a fixed facility (such as a
kiosk at a shopping center or an airport) or whether the stand is
located on unimproved real estate (such as a lot or field leased for
retail purposes).
Self-Certification and Employee Training
Q. How can I self-certify?
A. Businesses wishing to self-certify
can do so
online. The process is simple and requires providing the following
information:
1. DEA
Number (if applicable)
2. Tax
ID Business name
3. Address
Line1
4. Address
Line 2
5. City
6. State
7. Zip
Code
8. Point
of Contact (POC) Last Name
9. POC
First Name
10. POC Middle Initial
11. POC Email Address
12. POC Telephone Number
13. Number of employees trained
14. Total number of employees at
location
15. Type of establishment (e.g.
pharmacy)
16. Products handled
a. ephedrine
b. pseudoephedrine
c. phenylpropanolamine
Procedures are also available for
chains to register multiple locations in a single process. Information
regarding the chain self-certification process may be obtained by
contacting the DEA Registration Unit at 800-882-9539.
Q. Is there a fee for
self-certification?
A. At this time, DEA is not charging a
fee for self-certification of regulated sellers. DEA will be publishing
a Notice of Proposed Rulemaking regarding the charging of fees for
self-certification in the near future. At that time, DEA will seek
comment on this issue.
Q. CMEA requires me to train my employees
regarding the requirements of CMEA. Where do I find these training
materials?
A. DEA has developed training materials
for both retail vendors and mobile retail vendors which are available on
the
Diversion Control Program web site. You must use the content
of these training materials in the training of your employees who sell
scheduled listed chemical products. You may utilize additional content
in your training program, but DEA's posted material must be included.
Q. As part of self-certification, I am
required to train my employees on the requirements of CMEA. After my
employees are trained, is each employee required to self-certify?
A. No. Self-certification is
location-specific, not employee-specific. You are required to maintain
records regarding the training of your employees, but self-certification
is per location.
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