21 Code For Federal Regulation Parts 1305, 1311 Page 11
ADVERTISEMENT
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67Tracking number. Several commenters stated that the format of the unique tracking
number that a registrant assigns to an order was incorrect, that the last two digits of the year
should come first. DEA agrees and has corrected the rule.
Order contents. Commenters suggested several changes to the requirements for order
contents. DEA agrees that the complete address of the supplier could be provided by either the
purchaser or the supplier and has changed the rule. Similarly, DEA agrees that the order could
include either the National Drug Code (NDC) number or the drug name. DEA emphasizes that
the system used to view the orders must provide the drug description if the NDC code is used in
the order.
Linked records. Commenters objected to the use of the phrase “electronically linked”
records because they think that links could be electronic or manual. In technical discussions with
DEA, industry clarified that their concern was that DEA might interpret “electronically linked”
to require active rather than passive links, where all order data are linked automatically. Passive
links would allow the data to be stored in separate databases linked by one or more data elements
common to all records.
DEA emphasizes that it is not requiring any specific type of link; DEA’s only concern is
that if it requests copies of orders (e.g., for a particular customer or substance), the registrant
must be able to produce the requested records (i.e., both the electronic orders and the linked
distribution records) upon request in a format that an agent can read and understand. DEA has
revised the rule to clarify that “readable format” means that a person, not a computer, can easily
read the documents.
Corrections. Several commenters identified changes needed to correct regulatory
language. In § 1305.22(c)(1), DEA proposed that suppliers should verify the signature and order
11
ADVERTISEMENT
0 votes
Related Articles
Related forms
Core Ct Coding For Leave Of Absence Under The Federal Family And Medical Leave Act (fmla) - State Of Connecticut Human Resources
Business
Standard Form 8 - Unemployment Compensation For Federal Employees (ucfe) Program Notice To Federal Employee About Unemployment Insurance
Legal
Form St-r-21 - Application For Sale/use Tax Exemption Certificate For An Incorporated Hospital
Legal
Form As 2645.1 - Application For Tax Exemption Under Section 1101.01 Of The Internal Revenue Code For A New Puerto Rico
Financial
Related Categories
Parent category: Legal