Compliance
Regulatory Matters
Both federal and state laws govern the QuiqMedsTM business model for physicians to fulfill prescriptions for their patients. A recent survey indicated that physicians can prescribe and fulfill prescriptions for their patients in 45 states.
The Company's fulfillment system, including hardware, software and peripheral equipment used in the physician's offices, is not considered a medical device. Therefore, the regulations that are applicable to QuiqMeds involve regulations for physicians to fulfill prescriptions and regulations for supplying and distributing pharmaceuticals including storage, labeling and handling of the drugs.
The Federal Food Drug and Cosmetic Act as well as various state regulations set forth the measures by which QuiqMeds must operate in conjunction with their physician clients in prescribing and fulfilling prescriptions for their patients.
QuiqMeds is considered a wholesaler of pharmaceuticals and has obtained a license under the Pennsylvania Wholesale Prescription Drug Distributors License Act. It has set up policies and procedures for the distribution, storage, handling and labeling of prescription drugs. Further, QuiqMeds has set up a compliance program in which all policies are compliant with applicable federal, state and local regulations.
