Title II Licensure of Wholesale Distributors and 3PL’s
Title II ¨C Licensure of Wholesale
Distributors and 3PL¡¯s:
Where does FDA stand, where do states stand, what about
VAWD, and what can you do about it?
Elizabeth A. Gallenagh, Senior Vice President, Government Affairs and General
Counsel, Healthcare Distribution Management Association
Lori F. Hirsch, Managing Counsel, Merck & Co., Inc.
Moderated by Karla L. Palmer, Director, Hyman, Phelps & McNamara, PC and
Planning Committee Chair, Drug Quality and Security Act Conference
Title II ¨C DSCSA Licensure
? How and why did Title II address licensure?
? How are trading partners defined?
? Impact on manufacturers, wholesalers and 3PLs
? Current status and snapshot of state activity
2013 HDMA Map of State Pedigree
Legislation/Regulations
As of November 1, 2013
WA
ME
ND
MT
MN
OR
ID
NH
WI
SD
WY
IA
NE
NV
UT
CA
AZ
PA
IL
CO
KS
OK
NM
NY
MI
MO
AR
VA
NC
TN
GA
LA
HI
FL
AK
20
No Legislation
or Regulations
1
Proposed
Legislation
8
Enacted
Legislation
3
Enacted
Legislation,
Rules In
Development
18
RI
NJ
DE
MD
SC
AL
MA
CT
WV
KY
MS
TX
IN
OH
VT
Final Rules Adopted
DSCSA Licensure Overview
? Establishment of uniform national licensing standards for wholesale distributors
and 3PLs
? FDA is tasked with issuing regulations to further define those standards. States
will continue to license wholesale distributors and 3PLs, but they will be required
to do so utilizing the federal standards established.
? DSCSA provides that in the absence of a state licensing program that satisfies the
federal requirements, a federal licensing program will be established to license
wholesale distributors and 3PLs in those states.
Role of the States
? The Act prohibits any state or local government from
establishing or continuing any standards, requirements, or
regulations with respect to the licensing of wholesale
prescription drug distributors or third-party logistics
providers that are inconsistent with, less stringent, directly
related to, or covered by standards and requirements
applicable under section 503(e) (as amended by such Act) or
section 584 (for 3PLs).
? In other words, states cannot alter the standards established
by the Act, but they may continue to regulate wholesale
distributors and 3PLs in areas that are not covered by and not
directly related to the licensing standards in the Act.
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