Presented by: Sandra Stovall, J.D.,C.P.

A
STOVALL CONSULTING, LLC
  History

 State & Federal activity & requirements

◦ When a pedigree is required
Effective date
Type of transaction (drop shipment, outside normal distribution, returns)
Type of drug (human / vet)

◦ Who initiates it and what transactions are required

◦ What form may the pedigree take

Paper / electronic
Contents

◦ Authentication

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 HISTORY

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 States with pedigree laws / rules on January 1, 2007 (15)
States with pending pedigree legislation for 2007

WA

MT
ND VT ME
OR MN
WI NH
ID NY MA
SD
MI
WY
CT RI
IA PA
NE NJ
NV IL OH
UT IN
CO DE *
WV
KS MO KY VA MD
CA

TN NC
AZ
NM OK AR SC

GA
MS
TX AL
HI
LA
GA
AK
FL

States passing pedigree legislation in 2007 (7 - 1)

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 FLORIDA
EFFECTIVE JULY 1, 2006, a wholesaler is required to provide a
pedigree for all wholesale distributions to the recipient.

• Required for all Rx drugs (except Veterinary Legend

Drugs and Medical Gases)

“Rx Only” & convenience kits with Rx drug

components

• WHOLESALER TO WHOLESALER TO END USER

(pharmacy, hospital, practitioner)

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 FLORIDA
FLORIDA

DIRECT PURCHASE PEDIGREE STATEMENT

Purchased and received from the manufacturer

Distributed to end user / chain pharmacy warehouse

Statement (as opposed to document):

“This wholesale distributor purchased the specific unit of the
prescription drug directly from the manufacturer.”

S?
U LE
R

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 FLORIDA
FLORIDA

DROP SHIPMENT PEDIGREE STATEMENT

Manufacturer delivers directly to end user /
chain pharmacy warehouse

Wholesaler’s invoice must cross reference the manufacturer’s shipping

document
Sworn statement on invoice:
“This wholesale distributor purchased the specific unit of the prescription
drug listed on the invoice directly from the manufacturer, and the specific
unit of prescription drug was shipped by the manufacturer directly to a
person authorized by law to administer or dispense the legend drug, as
defined in s. 465.003, Florida Statutes, or a member of an affiliated group,
as described in s. 499.0121(6)(h), Florida Statutes, with the exception of a
repackager.”

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 FLORIDA
FLORIDA

FULL PEDIGREE
Document – paper or electronic

History or all distributions back to the manufacturer

Data elements identifying the drug, each party to the distribution(s),

and documentation for each distribution.

Wholesalers receiving a full pedigree are required to authenticate all

prior distributions.

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 Information
about this
particular sale.
FLORIDA

Information
about all the
previous
p Ph distributions.
shi ys
ner ic
a
w lm
/ o ov
les em
Sa en
t

Certification

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Informatio
n about the
repackager
’s sale

Information
about all
previous
distribution
s

Repackage
r’s
certificatio
n
 Verifying each transaction reflected on the
pedigree

v v
MANUFACTURER WHOLESALER WHOLESALER WHOLESALER

P P

Timing – on receipt /
prior to wholesale END USERS
distribution

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 CALIFORNIA

Similar to Florida’s full pedigree except the manufacturer will

be required to initiate the pedigree (implementation 2009)

Required for change in ownership – record shipping

information, including the name and address of each person
certifying delivery or receipt

MUST be electronic – “interoperable electronic system,

ensuring compatibility throughout all stages of distribution”
aka electronic track and trace system with unique identification
number

Return documented on same (receiving) pedigree

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 NEVADA
 Pedigree required to be provided to wholesaler customer if the
wholesaler :
• is not ADR for drug’s manufacturer
OR
• purchased the drug from a source other than the manufacturer

EPP (Electronic Pedigree Program) – beginning February 15, 2007

and monthly thereafter must transmit electronically pedigree
information to the Board
•Out-of-state wholesalers selling to Nevada customers where
pedigree was required
•In-state wholesalers who have engaged in any transaction for
which it must have received or provided a pedigree

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 OTHER STATE
APPROACHES
OUTSIDE NORMAL DISTRIBUTION CHANNEL

If outside normal distribution channel: full pedigree

PRE 2007 LEGISLATION

STATES: Arizona; Colorado; Indiana; Nebraska; Mississippi;

Oklahoma; Oregon; Texas; Virginia;
New Mexico(Rules)

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 OTHER STATE
APPROACHES
OUTSIDE NORMAL DISTRIBUTION CHANNEL
PRE 2007 LEGISLATION

What constitutes the “normal channel” varies –

3PL; exclusive distributor; specialty wholesale distributor; on
ADR list
Mfgr → W → end user
Mfgr → W → chain ph warehouse → affiliated ph end user
Mfgr → chain ph warehouse → affiliated ph end user
Mfgr /Colicensee → 3PL → W → end user
Mfgr → 3PL → W → chain ph warehouse → affiliated ph end user
Mfgr→3PL→ Excl Distrib→W→chain ph warehouse→affiliated ph end
user
Mfgr → W(ADR) → W(ADR) →chain ph warehouse→affiliated ph end user
Etc.

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 OTHER STATE
APPROACHES
PRE 2007 LEGISLATION

SUSCEPTIBLE DRUG LIST

New Jersey – list of high risk drugs

STUDY / WORKGROUP
Kansas - legislation died in 2007 session – carried over to 2008
Vermont- report recommended no pedigree legislation at this time
Connecticut – adjourned 6/6/2007 – no legislation

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 OTHER STATE
APPROACHES
PRE 2007 LEGISLATION

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  IDAHO (SB 1184) eff. 7/1/2007 (rules and form)
 MARYLAND (HB 1030) eff. 7/1/2007 (1/1/2008 rules)
 SOUTH DAKOTA (HB 1155) eff. 7/1/2007
 WYOMING (CH0211) eff. 7/1/2007 (rulemaking – 1/1/2009)

 GEORGIA (SB 205) eff 7/1/2007

 NORTH DAKOTA (HB 1444) eff. 8/1/2007
 MONTANA (HB 536) eff. 10/1/2007 (vetoed )

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 OTHER STATE
APPROACHES
OUTSIDE NORMAL DISTRIBUTION CHANNEL
2007 LEGISLATION – more uniformity

What constitutes the “normal channel” more consistent

Colicensee; 3PL; exclusive distributor;
Generally must be on ADR list

Directly or by drop shipment:

FROM TO
Mfgr → Pharmacy (end user)
Mfgr → Colicensee W → Pharmacy (end user)
Mfgr → 3PL W → Chain ph warehouse → affiliated ph end user
Mfgr→ Excl Distrib→ Chain ph warehouse → affiliated ph end user

Maryland & Georgia:

ADR → ADR → Office-based health care practitioner
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 OTHER STATE
APPROACHES
2007 LEGISLATION

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 OTHER STATE
APPROACHES
2007 LEGISLATION

Florida requires authentication to

occur upon receipt of the pedigree
and the prescription drug.

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  California requires returns to be reflected in
pedigree
 Florida – not required to be disclosed if returned
due to mistake in ordering or shipment
 New 2007 legislation –
Returns or exchanges of prescription drugs, saleable or
otherwise, including any redistribution by a receiving
wholesaler, are not subject to the pedigree requirements of …
if they are exempt from the pedigree requirements of the U.S.
Food and Drug Administration’s currently applicable
Prescription Drug Marketing Act Guidelines.
 PDMA – ADR’s do not have to provide pedigrees

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 FEDERAL PDMA
INJUNCTION

IMPLEMENTATION DATE

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 FEDERAL PDMA
 Complete pedigree rules not
implemented on December 1, 2006
◦ Back to manufacturer (now ADR or mfgr)
◦ Elements on pedigree not enforceable
(lot number, dosage, container size, and
quantity)
◦ Record retention still required
◦ ADR ongoing relationship defined –
written agreement
◦ Manufacturer must maintain ADR lists &
make available

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 FEDERAL PDMA

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  When a pedigree is required
◦ Resident state & state distributing to
◦ Effective date
◦ Type of transaction (drop shipment, outside normal distribution, returns)
◦ Type of drug

 Who initiates it and what transactions are

required
 What form may the pedigree take
◦ Paper / electronic
◦ Contents

 Authentication & retention requirements

STOVALL CONSULTING, LLC

 Determine whether you need to receive a
pedigree with your purchase of a
prescription drug.
If so, what do you need to do?

Inventory management

Determine whether you need to provide a

pedigree with your sale / distribution of
a prescription drug.
If so, what do you need to do?

STOVALL CONSULTING, LLC

  
Stovall Consulting, LLC
Sandra R. Stovall, J.D., C.P.A.
 
 
1769 Riverbirch Hollow
Tallahassee, Florida 32308
Office: 850-877-4357
Cell: 850-570-5230
srstovall@comcast.net

STOVALL CONSULTING, LLC