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Regulations &
Codified CSA > CFR > Section 1314
> Subpart B - Sales by Regulated Sellers
Section 1314 - Retail Sale of Scheduled Listed Chemical Products - Subpart B--Sales by Regulated Sellers
Sec. 1314.20 Restrictions on sales quantity.
(a) Without regard to the number of transactions, a regulated seller
(including a mobile retail vendor) may not in a single calendar day sell any
purchaser more than 3.6 grams of ephedrine base, 3.6 grams of pseudoephedrine
base, or 3.6 grams of phenylpropanolamine base in scheduled listed chemical
products.
(b) A mobile retail vendor may not in any 30-day period sell an
individual purchaser more than 7.5 grams of ephedrine base, 7.5 grams of
pseudoephedrine base, or 7.5 grams of phenylpropanolamine base in scheduled
listed chemical products.
Sec. 1314.25 Requirements for retail transactions.
(a) Each regulated seller must ensure that sales of a scheduled listed
chemical product at retail are made in accordance with this section and Sec.
1314.20.
(b) The regulated seller must place the product so that customers do
not have direct access to the product before the sale is made (in this
paragraph referred to as "behind-the-counter'' placement). For purposes of
this paragraph, a behind-the-counter placement of a product includes
circumstances in which the product is stored in a locked cabinet that is
located in an area of the facility where customers do have direct access.
Mobile retail vendors must place the product in a locked cabinet.
(c) The
regulated seller must deliver the product directly into the custody of the
purchaser.
Sec. 1314.30 Recordkeeping for retail transactions.
(a)(1) Except for purchase by an individual of a single sales package
containing not more than 60 milligrams of pseudoephedrine, the regulated
seller must maintain, in accordance with criteria issued by the Administrator,
a written or electronic list of each scheduled listed chemical product sale
that identifies the products by name, the quantity sold, the names and
addresses of the purchasers, and the dates and times of the sales (referred to
as the "logbook''). The logbook may be maintained on paper or in electronic
form.
(2) Effective November 27, 2006, if a logbook is maintained on paper, it
must be created and maintained in a bound record book.
(b) The regulated
seller must not sell a scheduled listed chemical product at retail unless the
purchaser does the following:
- Presents an identification card that
provides a photograph and is issued by a State or the Federal Government, or a
document that, with respect to identification, is considered acceptable for
purposes of 8 CFR 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B).
- Signs the
logbook and enters in the logbook his or her name, address, and the date and
time of the sale.
(c) For records created electronically, the regulated seller
may use an electronic signature system to capture the signature and may have
the computer automatically enter the date and time of the sale. The regulated
seller may ask the purchaser for their name and address and enter information
if it is not feasible for the purchaser to enter the information
electronically.
(d) The regulated seller must determine that the name entered
in the logbook corresponds to the name provided on identification presented
and that the date and time entered are correct.
(e) The regulated seller must
enter in the logbook the name of the product and the quantity sold. Examples
of methods of recording the quantity sold include the weight of the product
per package and number of packages of each chemical, the cumulative weight of
the product for each chemical, or quantity of product by Universal Product
Code. These examples do not exclude other methods of displaying the quantity
sold. For electronic records, the regulated seller may use a point-of-sale and
bar code reader. Such electronic records must be provided pursuant to
paragraph (i) of this section in a human readable form such that the
requirements of paragraph (a)(1) of this section are satisfied.
(f) The
regulated seller must include in the logbook or display by the logbook, the
following notice:
Warning: Section 1001 of Title 18, United States Code, states that whoever,
with respect to the logbook, knowingly and willfully falsifies, conceals, or
covers up by any trick, scheme, or device a material fact, or makes any
materially false, fictitious, or fraudulent statement or representation, or
makes or uses any false writing or document knowing the same to contain any
materially false, fictitious, or fraudulent statement or entry, shall be fined
not more than $250,000 if an individual or $500,000 if an organization, imprisoned not more than five
years, or both.
(g) The regulated seller must maintain each entry in the logbook for not
fewer than 2 years after the date on which the entry is made.
(h) A record
under this section must be kept at the regulated seller's place of business
where the transaction occurred, except that records may be kept at a single,
central location of the regulated seller if the regulated seller has notified
the Administration of the intention to do so. Written notification must be
submitted by registered or certified mail, return receipt requested, to the
Special Agent in Charge of the DEA Divisional Office for the area in which the
records are required to be kept.
(i) The records required to be kept under
this section must be readily retrievable and available for inspection and
copying by authorized employees of the Administration under the provisions of
21 U.S.C. 880.
(j) A record developed and maintained to comply with a State
law may be used to meet the requirements of this section if the record
includes the information specified in this section.
Sec. 1314.35 Training of sales personnel.
Each regulated seller must ensure that its sales of a scheduled listed
chemical product at retail are made in accordance with the following:
(a) In
the case of individuals who are responsible for delivering the products into
the custody of purchasers or who deal directly with purchasers by obtaining
payments for the products, the regulated seller has submitted to the
Administration a self-certification that all such individuals have, in
accordance with criteria issued by the Administration, undergone training
provided by the regulated seller to ensure that the individuals understand the
requirements that apply under this part.
(b) The regulated seller maintains a
copy of each self- certification and all records demonstrating that
individuals referred to in paragraph (a) of this section have undergone the
training.
Sec. 1314.40 Self-certification.
(a) A regulated seller must submit to the Administration the self-
certification referred to in Sec. 1314.35(a) in order to sell any scheduled
listed chemical product. The certification is not effective for purposes of
this section unless, in addition to provisions regarding the training of
individuals referred to in Sec. 1314.35(a), the certification includes a
statement that the regulated seller understands each of the requirements that
apply under this part and agrees to comply with the requirements.
(b) When a
regulated seller files the initial self-certification, the Administration will
assign the regulated seller to one of twelve groups. The expiration date of
the self-certification for all regulated sellers in any group will be the last
day of the month designated for that group. In assigning a regulated seller to
a group, the Administration may select a group with an expiration date that is
not less than 12 months or more than 23 months from the date of the self-
certification. After the initial certification period, the regulated seller
must update the self-certifications annually.
(c) The regulated seller must
provide a separate certification for each place of business at which the
regulated seller sells scheduled listed chemical products at retail.
Sec. 1314.42 Self-certification fee; time and method of
fee payment.
(a) A regulated seller must pay a fee for each
self-certification. For each initial application to
self-certify, and for the renewal of each existing
self-certification, a regulated seller shall pay a fee of $21.
(b) The fee for self-certification shall be waived for any
person holding a current, DEA registration in good standing as
a pharmacy to dispense controlled substances.
(c) A regulated seller shall pay the fee at the time of
self- certification.
(d) Payment shall be made by credit card.
(e) The self-certification fee is not refundable.
Sec. 1314.45 Privacy protections.
To protect the privacy of individuals who purchase scheduled listed
chemical products, the disclosure of information in logbooks under Sec.
1314.15 is restricted as follows:
(a) The information shall be disclosed as
appropriate to the Administration and to State and local law enforcement
agencies.
(b) The information in the logbooks shall not be accessed, used, or
shared for any purpose other than to ensure compliance with this title or to
facilitate a product recall to protect public health and safety.
(c) A
regulated seller who in good faith releases information in a logbook to
Federal, State, or local law enforcement authorities is immune from civil
liability for the release unless the release constitutes gross negligence or
intentional, wanton, or willful misconduct.
Sec. 1314.50 Employment measures.
A regulated seller may take reasonable measures to guard against employing
individuals who may present a risk with respect to the theft and diversion of
scheduled listed chemical products, 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.
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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