ID.
COVERED CONDUCT
A.
The "Covered Conduct" shall mean the following alleged conduct that occurred
between January
1,
2018 and the Effective Date
of
this Settlement Agreement, with respect
to
McKesson RxPak
's
D
EA
registration numbers RM0539734 and RR0276837.
1.
McKesson RxPak failed to maintain a complete and accurate record
of
each
controlled substance manufactured, imported, received, sold, delivered,
exported, or otherwise disposed
of
as required by 21 C.F.R. § 1304.2l(a) and
21
U.S.C.
§
827(a)(3), including failure to take an initial inventory
of
all stocks
of
controlled substances as required by
21
C.F.R. § 1304.1 l(b) and
21
U.S.C.
§
827(a)(l). Thus, an accountability audit in December
of
2018 revealed
overages in eight controlled substance
s.
2.
McKesson RxPak failed
to
maintain and execute DEA-222 forms for Schedule
II controlled substances as required by the CSA and its regulations. Examples
of
the alleged deficiencies include:
1.
Failure to maintain an undetermined number
of
Copy 3
of
DEA-222
fo
rms for purchases
of
Schedule II controlled substances;
11.
Failure to maintain at least one Copy 1
of
DEA-222 form for a sale
of
Schedule II controlled substances;
111.
Failure to correctly identify the supplier
's
DEA registration number
on Copies 1 and 2
of
DEA-222 forms on numerous occasions,
including instances where the custome
r'
s DEA registration number
was used in place
of
the supplier's
DEA
registration number;
iv.
Failure to timely submit Copy 2 DEA-222 forms to DEA on
numerous occasions; and
v.
Failure to maintain complete and accurate DEA-222 forms on
multiple occasions, resulting
in
inconsistencies between McKesson
RxPak
's
records and the information reported in ARCOS, including
discrepancies in ARCOS between McKesson RxPak's reported
sales and customers' reported purchases
of
controlled substances.
3.
McKesson RxPak failed to maintain separate records for each independent
activity for which they were registered, as required by
21
C.F.R.
§
l304.21(c)
and 21 U.S.C.
§
827(b)(2)(a).
For
instance, during the period August 7, 2018
through December 13, 2018, RxPak transferred 13,349 containers
of
Schedule
II controlled substances for three different drugs without maintaining Copy 1
of
DEA-222, and 36,313 containers
of
Schedule III-V controlled substances,
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