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Prescription Drug Importation Public Meeting April 14, 2004 PowerPoint Presentation
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Prescription Drug Importation Public Meeting April 14, 2004. Jim Rittenburg Authentix 610 861 6965 Drug Importation. Drug counterfeiting is a recognized global problem Incidence of fake drugs in US has been low due to FDA oversight

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Prescription Drug Importation

Public Meeting

April 14, 2004

Jim Rittenburg


610 861 6965

drug importation
Drug Importation
  • Drug counterfeiting is a recognized global problem
  • Incidence of fake drugs in US has been low due to FDA oversight
  • Even with FDA oversight, drug counterfeiting in US is increasing
  • Drug importation will bypass FDA and reduce safety
    • True origin of the drugs will become questionable
    • Drug storage and handling conditions will become questionable
  • The internet already represents a loosely controlled border
  • We do not believe that allowing drug importation is in the best interest
  • of the general population since it will put the drug supply at risk
ensuring drug safety
Ensuring Drug Safety
  • Even the current US drug supply chain requires more vigilance
  • Proven technologies exist today for protecting pharmaceuticals
  • Low impact technologies exist for packaging and dosage form
    • Readily integrated into manufacturing process
    • Relatively low cost
  • Overt and covert technologies will enable inspection by:
    • Consumers, Pharmacists, Healthcare Professionals
    • Pharma Manufacturers and Contracted Inspection Services
    • FDA, Customs, Other Government agencies
  • We believe as part of Good Manufacturing Practice all drug products
  • should be designed to minimize the opportunity for adulterated or
  • counterfeit product to reach the patient.
field audit programs
Field Audit Programs
  • We protect currency with layered security technologies
  • The same approach can work for pharmaceuticals
  • Presence of layered security features enable inspection
    • Overt Covert Forensic
    • Point of care Pharmacy Wholesaler Manufacturer
  • RFID technology and electronic pedigree’s
    • Will eventually complement authentication technologies
    • Unit level tag technology is still many years away
    • Comprehensive domestic and global infrastructure many years away
  • A low level ongoing field audit program will provide an
  • early warning system for flagging counterfeit product
overt and covert layers
Overt and Covert Layers


Depth of Security

Inspection levels

Color Shifting Ink


Field Visual


Field Disposable

Pen revealable marker


Field Instrument

Laser Authentication


Field Instrument

Spectral Fingerprint A


Spectral Fingerprint B

Laboratory Analysis


Laboratory Analysis

Field Disposable


Molecular Markers

- stable isotope

- binding pair

overt technologies
Overt Technologies
  • Polychromatic – Color Shifting - Security Inks
  • Holograms

Can be used independently or with other technologies such as tamper evident seals and strips

Combined with covert and forensic technologies, Holograms can provide a high level of protection.

covert technologies
Covert Technologies
  • Phosphors (up/down)
    • Invisible to Visible
    • Invisible to Invisible
  • Pen Revealable Covert Inks

Phosphors collect and store light, then release it only when exposed to light of specific wavelengths. Very high levels of security can be engineered into products using this technology.

Chemically reactive markers within the ink are revealed using appropriate developing reagents. Fixed or variable information can be applied using conventional printing equipment.


Authenticatingthe dosage form

  • Markers
  • Listed in CDER inactive ingredient guide
  • Simple organic GRAS compounds
  • Used in CDER approved products
  • Used at trace levels (ppm to ppb)
  • Inserted via coatings, inks, excipients,

or API

  • Marker Detection
  • Add tablet to liquid in vial
  • Shake briefly
  • Add several drops to test device
  • Read results:
    • 1 line is authentic
    • 2 lines is counterfeit

Inactive ingredients

become high security taggants

Field Test Kit