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NEW
FEDERAL METHAMPHETAMINE LAW RESTRICTING RETAIL
SALES
OF PSE BEGINS ON APRIL 8, 2006.
On
March 9, President Bush signed into law the USA Patriot Act Reauthorization, which places significant restrictions on the sales of
over-the-counter remedies containing pseudoephedrine (PSE).
The first phase of the federal restrictions goes into effect
April 8 of this year.
Contained
within the USA Patriot ACT is the Combat Methamphetamine Epidemic
Elimination Act (CMEEA),
which places significant restrictions on retail sales of
over-the-counter pseudoephedrine (PSE) products.
CMEEA allows retailers without pharmacies to continue selling
products containing PSE if they are sold from behind a service counter
or locked display case subject to the additional restrictions outlined
in this document. This
legislation does not impact wholesalers; it only restricts retail sales
of PSE containing products.
CMEEA
restrictions apply to all products containing PSE regardless of the form
– liquid, liquid-filled gel capsules and pediatrics are all
restricted. Alabama law
exempts liquid and liquid-filled gel capsule formulations, but the
federal does not.
Please
note that this does not preempt Alabama State Law, which was effective
July 1, 2005. In Alabama,
you still must do the following:
1.
All sole active ingredient products with ephedrine or
pseudoephedrine must be kept behind the counter or in locked case.
2.
When purchasing this product a person must sign a log, show a
photo ID or two forms of government issues ID and be 18 years of age.
3.
Over the counter sales are limited to two purchases or 3.6 grams
(beginning under federal law April 8, 2006).
4.
Combination products must be kept behind the counter or in a
locked case or under video surveillance with 30-day restriction.
5.
Liquid and gel-caps that were once preempted under Alabama law
are now enforced under federal law.
All
ephedrine (EPH) products are restricted in the manner as PSE products
under this law. EPH
products are less common and are typically sold as bronchodilators.
A well-known EPH product is Primatene in tablet form.
CMEEA
is phased-in two steps. The steps are explained below:
PSE
Restrictions Effective April 8, 2006
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Daily
Quantity Limit
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Retailers
may not sell to any consumer more than 3.6 grams of PSE
base in a single day. Current
Alabama law is 6.0 grams.
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30 Day
Quantity Limit
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Retailers
may not sell to any consumer more than 9 grams of PSE base
in a 30-day period. This
limit is in addition to the 3.6-gram daily limit, which remains in
effect.
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PSE
Restrictions Effective September 30, 2006
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Product
Placement
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All products
containing PSE must be placed and sold from behind a service
counter or from a locked display case.
The service counter must be an area inaccessible to
consumers. The
display case may be on the store floor.
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Photo ID
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In
conjunction with the logbook requirement, retailers will be
required to ask for photo identification, issued by either a State
or Federal Government or other appropriate identification.
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Logbook
Requirement
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A written or
electronic log of the transaction is required to be maintained.
The log must identify:
1.
Name of Product
2.
Quantity Sold
3.
Name and address of purchaser
4.
Signature of purchaser – may be written or electronic
5.
Date and time of sale
**A log is
not required to be kept for transactions involving a single sales
package of a PSE product, if that package contains not more than
60 milligrams (One 4-6 hour adult dose). **
6.
Logbook entries must be maintained for 2 years.
7.
Logbook must include a notice to purchasers that entering
false statements or misrepresentations in the logbook may subject
the purchasers to criminal penalties under section 1001 of title
18, United States Code. Notice
must specify the maximum fine and term of imprisonment under each
section.
8.
Retailers must maintain logbooks in a secure fashion.
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Mail
Order
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As of April
7, 2006, mail order sales of PSE products will be limited to 7.5
grams PSE per customer during a 30-day period.
Prior to shipping, the seller must verify the identity of
the purchaser in accordance with regulations to be issued by the
Department of Justice. Mail
orders that must be reported to the Attorney General are not
subject to the logbook, training or certification requirements.
Retail distributors who are otherwise exempt from the
current AG reporting requirement must, however, report
transactions related to PSE products.
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Training/DEA
Certification
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Retailers
must train all individuals who deliver PSE products to purchasers
and cashiers who receive payments for PSE products to ensure that
these persons understand the requirements that apply.
DEA will issue regulations on the training criteria.
Retailers must insure the following:
1.
Retailers must certify that all retail store employees who
conduct PSE sales transactions have been trained.
2.
Retailers must maintain certifications and records to
confirm employee training.
3.
Certifications must state that the retailer understands the
legal requirements and agrees to comply with them.
4.
Separate certifications are required for each place of
business.
5.
DEA will establish certification criteria through the
regulatory process, but must provide for self-certifications.
6.
State and local officials will have access to
certifications.
Retailers
will be able to submit self-certifications over an internet
website to be established by DEA and receive an acknowledgement of
that submission.
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Privacy
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DEA will
issue regulations governing the release of logbook information.
The regulations must provide for the following:
Information may be disclosed to federal, state and local
law enforcement agencies; Logbook information only permitted to
ensure compliance with this title or to facilitate a product
recall to protect public health or safety.
A retailer releases logbook information in good faith to
federal, state or local law enforcement authorities is immune from
civil liability.
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Diversion
Prevention
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Retailers
may take reasonable measures to guard against employing
individuals that may present a risk with respect to theft and
diversion, which may include, notwithstanding state law, asking
applicants for employment whether they have been convicted of any
crime involving or related to such products or controlled
substances.
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Duty of
Care
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Daily Limit:
Retailer is subject to civil and criminal penalties if
retailer sells products in violation of the daily 3.6 gram per
customer limit knowing at the time of the transaction involved
(independent of consulting the logbook) that the transaction is a
violation.
30-Day
Limit: Retailer is
subject to civil and criminal penalties if retailer knowingly or
recklessly sells products at retail in violation of the 9 gram per
customer 30-day period limit.
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The
following packaging guidelines represent the most common formats for PSE
products. Product packages
may vary from the specifications on this chart, so please be aware.
PSE Quantity
Guidelines
| Dosage
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PSE
Quantity
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Typical
Delivery
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Typical
Package Size/Total Quantity of PSE in Package
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Number
of Packages Within Daily 3.6 gram Limit
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Number
of Packages Within Monthly 9 gram Limit
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Infant
4-6 Hours
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15 mg
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1.6 ml
liquid or
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.5 fl
oz. (15 ml)
.14g
PSE per bottle
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25
bottles
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64
bottles
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2.5 ml
liquid
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1 fl.
oz (30 ml)
.18g
PSE per bottle
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20
bottles
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50
bottles
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Child
4-6 Hours
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30 mg
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10 ml
liquid or
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4 fl
oz. (118 ml)
.354g
PSE per bottle
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10
bottles
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25
bottles
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Two 15
mg tablets
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18
tablets
.27g
PSE per box
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13
boxes
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33
boxes
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Adult
4-6 Hours
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60 mg
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10 ml
liquid or
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4 fl.
oz (118 ml)
.708g
PSE per bottle
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5
bottles
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12
bottles
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Two 30
mg tablets
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24
tablets
.720g
PSE per box
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5 boxes
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12
boxes
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Adult
12 Hours
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120 mg
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Single
tablet
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10
tablets
1.2g
PSE per box
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3 boxes
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7
boxes
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20
tablets
2.4g
PSE per box
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1 box
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3
boxes
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Adult
24 Hours
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240 mg
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Single
tablet
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5
tablets
1.2g
PSE per box
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3 boxes
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7
boxes
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10
tablets
2.4g
PSE per box
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1 box
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3
boxes
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