category 1 banner

Category 1 Abuse Deterrent Studies

From study design to data submission, we offer rigorous research for safer products.

Studies for Category 1 drugs help protect human health by investigating the many ways a product’s formulation can be defeated or compromised. Studies explore how prescription medications may commonly be abused, along with the more advanced methods reported on drug abuse websites and forums. We’ve performed studies for a wide variety of AD (abuse-deterrent) drug formulations and non-AD comparator formulations, including opioids, stimulants and other medications that may be abused.

Today DRUGSCAN is a leader in conducting in vitro manipulation and extraction studies to satisfy Category 1 in the FDA’s guidance for innovator and generic formulations. Working with major abuse-deterrent product developers around the world, we’ve submitted more Category 1 drug study data to the FDA than any other standalone laboratory in the U.S. 

DRUGSCAN’s Category 1 study services include:

  • Design and execution in accordance with the FDA innovator and generic guidance
  • Extensive investigation into known or expected routes of abuse, relevant to the product
  • Physical and chemical manipulations using household tools or experienced abusers’ techniques: crushing, chewing, extractability, syringe-ability, smoke-ability, purification of active ingredients, nasal insufflation and dose-dumping
  • Skilled scientists with experience, proper training and regular competency verifications
  • Detailed protocols and standard operating procedures, along with independent quality assurance reviews to meet regulatory requirements
  • Adherence to tight timelines and requirements for robust label claims 
  • Controlled environments, state-of-the-art technologies and stringent reporting methods for data submission

About Our Lab

History and leadership

  • DRUGSCAN established in 1985
  • lab at DRUGSCAN’s Horsham, PA, location
  • 1,000 sq. ft. of access-controlled laboratories
  • More than six years of studies experience
  • Additional 9,000 sq. ft. of pharmaceutical lab space
  • Leadership team with decades of pharma experience

Quality assurance

  • CAP-accredited and SAMHSA-certified
  • CLIA and numerous state certifications
  • Independent quality assurance unit
  • CII-safe and DEA-certified to prevent substance diversion
  • Established SOPs, data management and reporting resources

Staffing & Technologies

  • 24/7 staffing, including two principal scientists
  • Dedicated air handling and analytical instruments
  • 23 LC-MS/MS instruments onsite
  • HLPC-UV, CAD and GC-MS instruments onsite
  • ERWEKA DRTTM chewing machine 

Choose DRUGSCAN for studies

For more information about our capabilities, contact us today.

Contact Us Today