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Regulations &
Codified CSA > CFR > Section 1314
> Subpart C - Mail Order Sales
Section 1314 - Retail Sale of Scheduled Listed Chemical Products - Subpart
C - Mail Order Sales
Subpart C--Mail-Order Sales
Sec. 1314.100 Sales limits for mail-order sales.
(a) Each regulated person who makes a sale at retail of a scheduled listed
chemical product and is required under Sec. 1310.03(c) of this chapter to
submit a report of the sales transaction to the Administration may not in a
single calendar day sell to 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) Each regulated person who
makes a sale at retail of a scheduled listed chemical product and is required
under Sec. 1310.03(c) of this chapter to submit a report of the sales
transaction to the Administration may not in any 30-day period sell to 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. 1314.105 Verification of identity for mail-order sales.
(a) Each regulated person who makes a sale at retail of a scheduled listed
chemical product and is required under Sec. 1310.03(c) of this chapter to
submit a report of the sales transaction to the Administration must, prior to
shipping the product, receive from the purchaser a copy of 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).
Prior to shipping the product, the regulated person must determine that the
name and address on the identification correspond to the name and address
provided by the purchaser as part of the sales transaction. If the regulated
person cannot verify the identities of both the purchaser and the recipient,
the person may not ship the scheduled listed chemical product.
(b) If the
product is being shipped to a third party, the regulated person must comply
with the requirements of paragraph (a) to verify that both the purchaser and
the person to whom the product is being shipped live at the addresses
provided. If the regulated person cannot verify the identities of both the
purchaser and the recipient, the person may not ship the scheduled listed
chemical product.
Sec. 1314.110 Reports for mail-order sales.
(a) Each regulated person required to report under Sec. 1310.03(c) of this
chapter must either:
- Submit a written report, containing the information
set forth in paragraph (b) of this section, on or before the 15th day of each
month following the month in which the distributions took place. The report
must be submitted under company letterhead, signed by the person authorized to sign on behalf of the
regulated seller, to the Drug and Chemical Evaluation Section, Office of
Diversion Control, Drug Enforcement Administration, Washington, DC 20537; or
- Upon request to and approval by the Administration, submit the report in
electronic form, either via computer disk or direct electronic data
transmission, in such form as the Administration shall direct. Requests to
submit reports in electronic form should be submitted to the Drug and Chemical
Evaluation Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, ATTN: Electronic Reporting.
(b) Each
monthly report must provide the following information for each distribution:
- Supplier name and registration number;
- Purchaser's name and address;
- Name/address shipped to (if different from purchaser's name/ address);
- Method used to verify the identity of the purchaser and, where applicable,
person to whom product is shipped;
- Name of the chemical contained in the
scheduled listed chemical product and total quantity shipped (e.g.
pseudoephedrine, 3 grams);
- Date of shipment;
- Product name;
- Dosage
form (e.g., tablet, liquid);
- Dosage strength (e.g., 30mg, 60mg, per dose
etc.);
- Number of dosage units (e.g., 100 doses per package);
- Package
type (blister pack, etc.);
- Number of packages;
- Lot number.
Sec. 1314.115 Distributions not subject to reporting requirements.
(a) The following distributions to nonregulated persons are not subject to
the reporting requirements in Sec. 1314.110:
- Distributions of sample
packages when those packages contain not more than two solid dosage units or
the equivalent of two dosage units in liquid form, not to exceed 10
milliliters of liquid per package, and not more than one package is
distributed to an individual or residential address in any 30-day period.
- Distributions by retail distributors that may not include face- to-face
transactions to the extent that such distributions are consistent with the
activities authorized for a retail distributor as specified in Sec.
1300.02(b)(29) of this chapter, except that this paragraph (a)(2) does not
apply to sales of scheduled listed chemical products at retail.
- Distributions to a resident of a long term care facility or distributions to a
long term care facility for dispensing to or for use by a resident of that
facility.
- Distributions in accordance with a valid prescription.
(b) The
Administrator may revoke any or all of the exemptions listed in paragraph (a)
of this section for an individual regulated person if the Administrator finds
that drug products distributed by the regulated person are being used in
violation of the regulations in this chapter or the Controlled Substances Act.
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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