[Federal Register Volume 69, Number 14 (Thursday, January 22, 2004)]
[Corrections]
[Pages 3198-3199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: C4-722]



  Federal Register / Vol. 69, No. 14 / Thursday, January 22, 2004 / 
CORRECTIONS  

[[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:

------------------------------------------------------------------------
 
------------------------------------------------------------------------
Qualifications and Requirements for the Exemption of Sales of ``Ordinary
    Over-the-Counter Pseudoephedrine or Phenylpropanolamine Regulated
      Products'' (``Safe Harbor Products'') by Retail Distributors
------------------------------------------------------------------------
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))
------------------------------------------------------------------------
Requirements and conditions if       Requirements and conditions if
 retail distributor qualifies for     retail distributor does not
 the exemption                        qualify for the exemption
------------------------------------------------------------------------
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.).
------------------------------------------------------------------------



[[Page 3199]]

[FR Doc. C4-722 Filed 1-21-04; 8:45 am]
BILLING CODE 1505-01-D