[Federal Register: January 22, 2004 (Volume 69, Number 14)]
[CORRECTIONS]
[Page 3198-3199]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ja04-128]
[[Page 3198]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1309, 1310
[Docket No. DEA-239T]
Clarification of the Exemption of Sales by Retail Distributors of
Pseudoephedrine and Phenylpropanolamine Products
Correction
In rule document 04-722 beginning on page 2062 in the issue of
Wednesday, January 14, 2004, make the following correction:
On page 2065, the table is corrected to read as follows:
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Qualifications and Requirements for the Exemption of Sales of ``Ordinary
Over-the-Counter Pseudoephedrine or Phenylpropanolamine Regulated
Products'' (``Safe Harbor Products'') by Retail Distributors
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Seller must first meet the definition of retail distributor relating to
regulated pseudoephedrine, phenylpropanolamine, or ephedrine products
listed below:
1. 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--
2. Limited to sales almost exclusively for personal use, both in the
number of sales and volume of sales [regardless of the packaging of the
products].
Sale for personal use means the sale of below-threshold quantities in a
single transaction to an individual for legitimate medical use.
AND
3. Sales are made either directly to walk-in customers or face-to-face
by direct sales. (21 U.S.C. 802(46) & 21 CFR 1300.02(b)(29))
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Requirements and conditions if Requirements and conditions if
retail distributor qualifies for retail distributor does not
the exemption qualify for the exemption
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DEA registration as a distributor Seller must register with DEA as a
of List I chemicals is waived. (21 distributor of List I chemicals.
CFR 1309.23(e)). (21 CFR 1309)
As a regulated person whose Distributor must meet security
registration has been waived, a requirements for List I chemicals
retail distributor must meet in 21 CFR 1309.71-1309.73.
security requirements for List I
chemicals found in 1309.71-
1309.73. (21 CFR 1309.24(k)).
As a regulated person whose Distributor is subject to the
registration has been waived, a reporting requirements for listed
retail distributor is subject to chemicals in 21 CFR 1310.
the to the reporting requirements
for regulated transactions
requirements of listed chemicals
in 21 CFR 1310.05. (21 CFR
1309.24(k)).
No records are required for sales No records are required for sales
of regulated pseudoephedrine or of regulated pseudoephedrine or
phenylpropanolamine products below phenylpropanolamine products below
threshold quantities in a single threshold quantities in a single
transaction regardless of transaction regardless of
packaging (not a regulated packaging (not a regulated
transaction). transaction).
Records must be retained for all Records must be retained for all
sales of threshold and above transactions of threshold or above
quantities of pseudoephedrine and quantities regardless of type of
phenylpropanolamine regulated packaging (regulated
products not in blister packs transactions). (21 CFR 1310)
(such as bottles), which are
regulated transactions, as set
forth in 21 CFR 1310.
If sales of pseudoephedrine or For all transactions at or above
phenylpropanolamine regulated threshold amounts (regulated
products exceed ``almost transactions), distributor must
exclusively below-threshold'' meet proof of identity
amounts either in number of sales requirements for customers. (21
or volume of sales--regardless of CFR 1310.07)
the kind of packaging, then seller
must register with DEA as a
distributor of List I chemicals.
(See the other side of this table--
Requirements and Conditions If
Retail Distributor Does Not
Qualify for the Exemption.).
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[[Page 3199]]
[FR Doc. C4-722 Filed 1-21-04; 8:45 am]
BILLING CODE 1505-01-D