Legend Drug & Controlled Substance Sampling Compliance Modules

This module provides comprehensive state-specific laws and regulations governing pharmaceutical sampling to physicians. 

Updated quarterly, this PCM sets forth all means of compliant distribution, addressing both representative sample distribution and common carrier programs. 

It is a handy, practical and easy-to-use reference guide for sales operations professionals, compliance personnel and in-house counsel.

Distribution: Trade and Sample

The Distribution: Trade and Sample module provides comprehensive state-specific laws and regulations governing wholesale distribution of prescription drugs in all 50 states and Washington, D.C. 

Updated quarterly, this PCM contains seven distinct easy-to-use components addressing every major aspect of wholesale distribution compliance. 

It is an interactive reference guide for sales operations professionals, compliance personnel and in-house counsel.

The Module details the following aspects of wholesale distribution regulation:

• Written policies and procedures
• Record keeping requirements
• Application requirements
• Licensing requirements
• Storage and handling
• Violations
• Pedigree / Authorized distributor

Pedigree Requirements

Our Pedigree Requirements Module focuses on enacted laws, regulations and pending pedigree legislation in each state. The module provides specific information on all requirements, such as: 

• Quantity, strength and dosage of prescription drugs
• Drug types subject to legislation
• Exemptions
• Manufacturer information
• Wholesaler(s) information
• Chain of custody
• Authentication
• Electronic or paper requirement

Mid-level Practitioner Sampling Authority

The Mid-level Practitioner Sampling Authority Compliance Module provides comprehensive state-specific laws and regulations governing the sampling of legend and controlled substances to eleven distinct classifications of mid-level practitioners. 

This PCM sets forth the prescribing authority of mid-level practitioners in all 50 states and Washington, DC. 

It is a handy, practical and easy-to-use reference guide for sales operations professionals, compliance personnel and in-house counsel.

The standard Module addresses the following eleven distinct classifications of practitioners, but can be customized to include any or all other classes of mid-levels:

• Midwives and Certified Midwives
• Certified Registered Nurse Anesthetists
• Clinical Nurse Specialists
• Dentists
• Nurse Practitioners
• Physician Assistants
• Psychologists
• Podiatrists
• Optometrists
• Veterinarians

Transparency and Limitations

The Transparency and Limitations Module provides an overview of laws, regulations and pending legislation pertaining to industry interactions with healthcare practitioners and consumers. Module includes a summary of state and federal requirements and restrictions related to marketing and sales, prescriber data, drug pricing, PBMs, clinical trials and advertising.