Title VII of Public Law
109-177 > The Combat Meth Act of 2005
General Information Regarding
The Combat Methamphetamine Epidemic Act of 2005
[Title VII of Public Law 109-177]
Drug Enforcement Administration
May 2006
The Combat Methamphetamine Epidemic Act of 2005 (Title
VII of the USA PATRIOT Improvement and Reauthorization Act of
2005, P.L. 109-177) was signed into law March 9, 2006. All
changes go into effect on March 9, 2006, (date the legislation
was signed) unless a later effective date is specifically
stated. This document discusses those changes made by the Combat
Methamphetamine Epidemic Act which primarily affect persons
selling products containing the List I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine. Other actions taken by
the Combat Methamphetamine Epidemic Act are not discussed here.
Effective March 9, 2006
The Act makes definitional changes to add "scheduled
listed chemical product," "regulated seller,"
"mobile retail vendor," "at retail," and to
modify the existing definition of "retail
distributor." Definitions are as follows:
"The term scheduled listed chemical product means,…a
product that—
(i) contains ephedrine, pseudoephedrine, or
phenylpropanolamine; and
(ii) may be marketed or distributed lawfully in the United
States under the Federal, Food, Drug, and Cosmetic Act as a
nonprescription drug.
Each reference in clause (i) to ephedrine, pseudoephedrine,
or phenylpropanolamine includes each of the salts, optical
isomers, and salts of optical isomers of such chemical."
"The term regulated seller means a retail
distributor (including a pharmacy or a mobile retail vendor),
except that such term does not include an employee or agent of
such distributor."
"The term mobile retail vendor means 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)."
"The term at retail, with respect to the sale or
purchase of a scheduled listed chemical product, means a sale or
purchase for personal use, respectively."
"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
pseudoephedrine or phenylpropanolamine products 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."
Effective April 8, 2006
a. The change to 21
U.S.C. § 830 that adds a new subsection (d) SCHEDULED
LISTED CHEMICALS; RESTRICTIONS ON SALES QUANTITY; REQUIREMENTS
REGARDING NONLIQUID FORMS:
i. This sets the daily sales limit of ephedrine base,
pseudoephedrine base, or phenylpropanolamine base at 3.6 grams
per purchaser, regardless of the number of transactions.
ii. Affects regulated sellers and persons required to
submit mail order reports under 21 U.S.C. 830(b)(3).
iii. Requires all nonliquid forms (including gel caps) to
be in 2-unit blister packs (with exception when blister pack
is not technically feasible, the product may be in unit dosage
packets or pouches).
b. The change to 21 U.S.C. § 830 that adds (2) MAIL-ORDER
REPORTING; VERIFICATION OF IDENTITY OF PURCHASER; 30-DAY
RESTRICTION ON QUANTITIES FOR INDIVIDUAL PURCHASES:
i. This requires the mail-order seller to confirm the
identity of the purchaser prior to shipping the product.
ii. Limits such sales to 7.5 grams per customer during a
30-day period.
c. The change to 21
U.S.C. § 844(a) entitled RESTRICTIONS ON QUANTITY PURCHASED
DURING 30-DAY PERIOD:
i. This makes it unlawful for any person to knowingly or
intentionally purchase at retail more than 9 grams during a 30
day period (of which no more than 7.5 grams can be imported by
private or commercial carrier or the Postal Service).
Effective September 30, 2006
Sales limits
a. A mobile retail vendor may not sell more than 7.5 grams of
product per customer during a 30-day period.
Product Placement
b. Regulated seller must place product such that customers do
not have direct access before the sale is made ("behind the
counter" placement) or in a locked cabinet that is located
in an area of the facility to which customers do have direct
access. Regulated seller must deliver product directly into the
custody of the purchaser.
c. A mobile retail vendor must place product in a locked
cabinet.
Logbook Provisions
d. Seller maintains written or electronic list (logbook) of
sales that identifies:
(1) Products by name;
(2) Quantity sold;
(3) Names and addresses of purchasers; and,
(4) Date and time of the sales.
The logbook requirement does not apply to any purchase by an
individual of a single sales package that contains not more than
60 mg. of pseudoephedrine.
e. Seller may not sell the product unless prospective
purchaser presents a photographic identification card issued by
a State or the Federal Government, or a document considered
acceptable for purposes of 8 CFR § 274a.2(b)(1)(v)(A) or (B).
f. Purchaser must sign the logbook and enter his or her name,
address, and date and time of sale.
g. Seller must determine that the name entered into the
logbook corresponds to the name provided on such identification
and that the date and time entered are correct.
h. Seller must enter into the logbook the name of the product
and the quantity sold.
i. The logbook must contain a notice to purchasers that
entering false statements or misrepresentations in the logbook
may subject the purchaser to criminal penalties under 18 U.S.C.
§ 1001 and such notice must specify the maximum fine
($250,000.00) and term of imprisonment (5 years).
j. Seller must maintain each entry in the logbook for not
fewer than two years after the date on which the entry is made.
k. The Attorney General will issue regulations establishing
restrictions on disclosure of information in logbooks.
Disclosure to the Attorney General and to State and local law
enforcement agencies will be authorized. Accessing, using, or
sharing the logbook information for any purpose other than to
comply with the Controlled Substances Act or to facilitate a
product recall to protect public health and safety will be
prohibited.
l. Regulated seller who in good faith releases logbook
information to Federal, State or local law enforcement
authorities is immune from civil liability for such release
unless the release constitutes gross negligence or intentional,
wanton, or willful misconduct.
Self-Certification and Training
m. Self-certification and training.
(1) Seller must self-certify to the Attorney General that
each individual who is responsible for delivering such
products into the custody of purchasers, or who deals directly
with purchasers by obtaining payment for the products, has
undergone training provided by the seller to ensure that the
individual understands the requirements that apply to the sale
of these products.
(2) Regulated seller may not sell any scheduled listed
chemical product at retail unless the self-certification has
been submitted to the Attorney General.
(3) Seller must maintain a copy of such self-certification
and records demonstrating that individuals have undergone such
training.
(4) The certification is not effective unless, in addition
to provisions regarding the training of individuals, the
certification includes a statement that the seller understands
each of the requirements regarding transactional limits,
blister-packs, "behind the counter" placement, photo
identification, and logbook also apply and agrees to comply
with the requirements.
(5) The Attorney General will issue regulations to
establish the criteria for self-certifications and employee
training. Separate certification is required for each place of
business at which a regulated seller sells such products at
retail.
(6) The Attorney General will establish a program that
will:
(a) be carried out through an Internet site of the
Department of Justice;
(b) inform regulated sellers that 18 U.S.C. § 1001
applies to such certifications;
(c) make available to sellers the criteria for
certification and training;
(d) be designed to permit submission of certifications
through the Internet site; and
(e) be designed to automatically provide the explanation
of the criteria for certification and training and an
acknowledgment that the Department of Justice has received a
certification, without requiring direct interaction of
regulated sellers with staff of the Department of Justice.
(7) Copies of certifications shall be made available to
appropriate State and local officials.
Equivalency Charts
The following is not found within DEA law or regulations; DEA
provides this for informational purposes only:
A. Effective April 8, 2006, the daily sales limit of
ephedrine base, pseudoephedrine base, or phenylpropanolamine
base is 3.6 grams per purchaser, regardless of number of
transactions.
Ingredient |
Number of Tablets [as base] |
25 mg Ephedrine HCl |
175 |
25 mg Ephedrine Sulfate |
186 |
30 mg Pseudoephedrine HCl |
146 |
60 mg Pseudoephedrine HCl |
73 |
120 mg Pseudoephedrine HCl |
36 |
30 mg Pseudoephedrine Sulfate |
155 |
60 mg Pseudoephedrine Sulfate |
77 |
120 mg Pseudoephedrine Sulfate |
38 |
Phenylpropanolamine |
The Food and Drug Administration issued a voluntary
recall of this ingredient as being unsafe for human
consumption. Veterinary use is by prescription only. |
Ingredient |
Number of Milliliters (ml) [as base] |
6.25 mg/5 ml Ephedrine HCl |
3515 |
15 mg/1.6 ml Pseudoephedrine HCl |
468 |
7.5 mg/5 ml Pseudoephedrine HCl |
2929 |
15 mg/5 ml Pseudoephedrine HCl |
1464 |
15 mg/2.5 ml Pseudoephedrine HCl |
732 |
30 mg/5 ml Pseudoephedrine HCl |
732 |
30 mg/2.5 ml Pseudoephedrine HCl |
366 |
60 mg/5 ml Pseudoephedrine HCl |
366 |
Phenylpropanolamine |
The Food and Drug Administration issued a voluntary
recall of this ingredient as being unsafe for human
consumption. Veterinary use is by prescription only. |
B. Effective April 8, 2006, for mail-order sellers, sales
are limited to 7.5 grams per customer during a 30-day period.
Ingredient |
Number of tablets [as base] |
25 mg Ephedrine HCl |
366 |
25 mg Ephedrine Sulfate |
389 |
30 mg Pseudoephedrine HCl |
305 |
60 mg Pseudoephedrine HCl |
152 |
120 mg Pseudoephedrine HCl |
76 |
30 mg Pseudoephedrine Sulfate |
324 |
60 mg Pseudoephedrine Sulfate |
162 |
120 mg Pseudoephedrine Sulfate |
81 |
Phenylpropanolamine |
The Food and Drug Administration issued a voluntary
recall of this ingredient as being unsafe for human
consumption. Veterinary use is by prescription only. |
Ingredient |
Number of Milliliters (ml) [as base] |
6.25 mg/5 ml Ephedrine HCl |
7323 |
15 mg/1.6 ml Pseudoephedrine HCl |
976 |
7.5 mg/5 ml Pseudoephedrine HCl |
6103 |
15 mg/5 ml Pseudoephedrine HCl |
3051 |
15 mg/2.5 ml Pseudoephedrine HCl |
1525 |
30 mg/5 ml Pseudoephedrine HCl |
1525 |
30 mg/2.5 ml Pseudoephedrine HCl |
762 |
60 mg/5 ml Pseudoephedrine HCl |
762 |
Phenylpropanolamine |
The Food and Drug Administration issued a voluntary
recall of this ingredient as being unsafe for human
consumption. Veterinary use is by prescription only. |
C. Effective April 8, 2006, it is unlawful for any person to
knowingly or intentionally purchase at retail more than 9 grams
during a 30-day period (of which no more than 7.5 grams can be
imported by private or commercial carrier or the Postal
Service).
Ingredient |
Number of tablets
(7.5 gm) [as base] |
Number of tablets
(9 gm) [as base] |
25 mg Ephedrine HCl |
366 |
439 |
25 mg Ephedrine Sulfate |
389 |
466 |
30 mg Pseudoephedrine HCl |
305 |
366 |
60 mg Pseudoephedrine HCl |
152 |
183 |
120 mg Pseudoephedrine HCl |
76 |
91 |
30 mg Pseudoephedrine Sulfate |
324 |
389 |
60 mg Pseudoephedrine Sulfate |
162 |
194 |
120 mg Pseudoephedrine Sulfate |
81 |
97 |
Phenylpropanolamine |
The Food and Drug Administration issued a voluntary
recall of this ingredient as being unsafe for human
consumption. Veterinary use is by prescription only. |
Ingredient |
Number of milliliters
(ml) (7.5 gm) [as base] |
Number of milliliters
(9 gm) [as base] |
6.25 mg/5 ml Ephedrine HCl |
7323 |
8788 |
15 mg/1.6 ml Pseudoephedrine HCl |
976 |
1171 |
7.5 mg/5 ml Pseudoephedrine HCl |
6103 |
7323 |
15 mg/5 ml Pseudoephedrine HCl |
3051 |
3661 |
15 mg/2.5 ml Pseudoephedrine HCl |
1525 |
1830 |
30 mg/5 ml Pseudoephedrine HCl |
1525 |
1830 |
30 mg/2.5 ml Pseudoephedrine HCl |
762 |
915 |
60 mg/5 ml Pseudoephedrine HCl |
762 |
915 |
Phenylpropanolamine |
The Food and Drug Administration issued a voluntary
recall of this ingredient as being unsafe for human
consumption. Veterinary use is by prescription only. |
D. Effective September 30, 2006, for mobile retail vendors,
sales are limited to 7.5 grams per customer during a 30-day
period.
Ingredient |
Number of tablets [as base] |
25 mg Ephedrine HCl |
366 |
25 mg Ephedrine Sulfate |
389 |
30 mg Pseudoephedrine HCl |
305 |
60 mg Pseudoephedrine HCl |
152 |
120 mg Pseudoephedrine HCl |
76 |
30 mg Pseudoephedrine Sulfate |
324 |
60 mg Pseudoephedrine Sulfate |
162 |
120 mg Pseudoephedrine Sulfate |
81 |
Phenylpropanolamine |
The Food and Drug Administration issued a voluntary
recall of this ingredient as being unsafe for human
consumption. Veterinary use is by prescription only. |
Ingredient |
Number of Milliliters (ml) [as base] |
6.25 mg/5 ml Ephedrine HCl |
7323 |
15 mg/1.6 ml Pseudoephedrine HCl |
976 |
7.5 mg/5 ml Pseudoephedrine HCl |
6103 |
15 mg/5 ml Pseudoephedrine HCl |
3051 |
15 mg/2.5 ml Pseudoephedrine HCl |
1525 |
30 mg/5 ml Pseudoephedrine HCl |
1525 |
30 mg/2.5 ml Pseudoephedrine HCl |
762 |
60 mg/5 ml Pseudoephedrine HCl |
762 |
Phenylpropanolamine |
The Food and Drug Administration issued a voluntary
recall of this ingredient as being unsafe for human
consumption. Veterinary use is by prescription only. |
General Information Regarding
The Combat Methamphetamine Epidemic Act of 2005
[Title VII of Public Law 109-177]
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