Pedigree Laws

Camber Hayman, J.D.

Director – Pharmacy Sourcing Services
Broadlane, Inc.
 What is a Counterfeit Drug?
• Look-alike drug that either has reduced, hazardous, or
no active ingredient
• Expired drugs that have been relabeled
• Fake drugs
• Drugs rejected by the manufacturer
• Drugs that have been adulterated, repackaged, or
imported unlawfully
 What Are Pedigree Laws?
• Prescription Drug Marketing Act was enacted in 1987 (“PDMA”),
creating prescription drug pedigrees -enforcement delayed by FDA
– Purpose to prevent diversion (re-sale)/counterfeiting of drugs
– Patient Safety
– Protection of supply of medicine
– Strong chain of custody requirements from manufacturer to pharmacy,
including strong data and licensure requirements for distributors
– American-manufactured prescription drugs for human consumption
cannot be re-imported
– Regulates distribution of drug samples
– Regulates wholesale distributors
– Requires pedigree from unauthorized (secondary) wholesalers
• States may enforce stricter standards
• California and Florida laws apply to ALL wholesalers

• Federal Rules take effect in December, 2006

 Federal Pedigree Requirements
• Requirements
– Each prior transaction must be documented
– Proprietary Name of Drug
– Established (known) name of drug
– Number of containers in order
– Container size
– Strength
– Lot number of batch
– Business name
– Business address
– Date of transaction
Status of Pedigree
Laws by State
WA MT ND

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

O TN NC
AZ NM K AR

M SC
S
AL GA
TX LA

AK AK FL

HI
H
I
Florida and California Leading the Way
• Florida law effective July 1, 2006
– Written or electronic form
– Applies to any wholesaler or re-packager until final sale to pharmacy
– Wholesaler 100% responsible for certification of pedigree
– Pharmacists must maintain records for three years
• California law effective January 1, 2007
– Electronic form only
– Pharmacy required to provide pedigree at time of sale or transfer
– March 2006 CA Bd. Of Pharmacy – may delay until 2009
• Florida and California purchase majority of pharmaceuticals in
nation
• Wholesalers must be able to meet the varying requirements of each
state that has enacted laws
• Criminal penalties for counterfeiting or forgery of chain of custody
documents in some states
• FDA enforcement of PDMA in December, 2006
Manufacturer

Pedigree by Wholesaler [Federal or State]

Wholesaler

Pedigree by Wholesaler or Pharmacy

[Federal or State]

Pharmacy To Avoid Counterfeit

 Issues
• Development and industry adoption of new technology
– High Frequency vs. Ultra-High Frequency radio tags (RFID)
– Bar-coding insufficient
– Effect of radio frequencies on biological drugs unknown
– More difficult to tag individual items vs. bulk
– Ensuring uniformity with varying technologies
• Breaking the chain of protection
– Secondary wholesalers break down bulk and resell in smaller
units
– Potential for fraud or record-keeping failure
• Possible drug shortages if drop shipments are delayed or prevented
– wholesalers are responsible for authenticating the pedigree and
cannot authenticate on drop shipments, because they don’t
handle the product
• Variations in state laws
 What does this mean to pharmacists and
buyers?
• Possible last stage of certification of pedigree
• Review the laws in your state to determine the impact on your
supply chain practices such as
– drop shipments
– returns
– valid certification by you but error in pedigree chain beyond your control
• Check with your reverse distributors to see how this may affect your
returns
• Tighter inventory control and planning in case of delay in delivery or
shortages
• Possible confusion and resulting delay for wholesalers that meet the
requirements of one state but not another
• If the hospital is involved in the final certification, is your hospital
equipped with technology to integrate with the various available
technologies?
THE END

Have a good day!