Office of Diversion Control, US Department of Justice, Drug Enforcement Administration

RESOURCES > Federal Register Notices > Rules - 2004 > Clarification of the Exemption of Sales by Retail Distributors of  Pseudoephedrine and Phenylpropanolamine Products; Correction

Rules - 2004

FR Doc C4-722
[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:

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 retail distributor qualifies for the exemption Requirements and conditions if retail distributor does not qualify for the exemption
DEA registration as a distributor of List I chemicals is waived. (21 CFR 1309.23(e)).
Seller must register with DEA as a distributor of List I chemicals. (21 CFR 1309)
As a regulated person whose registration has been waived, a retail distributor must meet security requirements for List I  chemicals found in 1309.71-1309.73. (21 CFR 1309.24(k)).
Distributor must meet security requirements for List I chemicals in 21 CFR 1309.71-1309.73.
As a regulated person whose registration has been waived, a retail distributor is subject to the to the reporting requirements for regulated transactions requirements of listed chemicals in 21 CFR 1310.05. (21 CFR 1309.24(k)).
Distributor is subject to the reporting requirements for listed chemicals in 21 CFR 1310.
No records are required for sales of regulated pseudoephedrine or phenylpropanolamine products below threshold quantities in a single transaction regardless of packaging (not a regulated transaction).
No records are required for sales of regulated pseudoephedrine or phenylpropanolamine products below threshold quantities in a single transaction regardless of packaging (not a regulated transaction).
Records must be retained for all sales of threshold and above quantities of pseudoephedrine and phenylpropanolamine regulated products not in blister packs (such as bottles), which are regulated transactions, as set forth in 21 CFR 1310.
Records must be retained for all transactions of threshold or above quantities regardless of type of packaging (regulated transactions). (21 CFR 1310)
If sales of pseudoephedrine or phenylpropanolamine regulated products exceed "almost  exclusively below-threshold" amounts either in number of sales or volume of sales--regardless of 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.). For all transactions at or above threshold amounts (regulated transactions), distributor must meet proof of identity requirements for customers. (21 CFR 1310.07)

[[Page 3199]]

[FR Doc. C4-722 Filed 1-21-04; 8:45 am]

BILLING CODE 1505-01-D

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).

Emergency Disaster Relief
Got Drugs? Turn in your unused or expired medication for safe disposal here.
Alert! Extortion Scam

U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Office of Diversion Control  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539