# Presentation: 621198

## Prescription Drug Importation

***Prescription Drug Importation***
***Public Meeting****** ***
***April 14,  2004***

***Jim Rittenburg***
***Authentix ***
***610 861 6965***
***www.authentix.com***

## 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

**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

**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 ****  ***

## Protecting the product

## Overt and Covert Layers

**Covert          ****	**

**Covert          ****	**

**Forensic   ****	**

**Covert          ****	**

**Color Shifting Ink**
**Holograms**

**Pen revealable marker**

**Laser Authentication**

**Spectral Fingerprint A**

**Spectral Fingerprint B**

**Forensic   ****	**

**Molecular Markers**
** ****- stable isotope**
** ****- binding pair**

**Field Visual**

**Field Disposable**

**Field Instrument**

**Field Instrument**

**Laboratory Analysis**

**Laboratory Analysis **
**Field Disposable**

**Depth of Security**

**Technologies**

**Inspection levels **

## Overt Technologies

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

- Polychromatic – Color Shifting - Security Inks

- Holograms

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

## Covert Technologies

**Pen Revealable Covert Inks**

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

**Phosphors (up/down)**
- Invisible to Visible
- Invisible to Invisible

***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.***

## Authenticating the dosage form

- Authenticating the 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***