Compliance, Regulatory & Quality Consultants

While the FDA regulates and preempts the filed regarding the manufacturing and distribution of drugs and other healthcare products within the US stream of commerce; some US states have also decided to regulate the distribution within its state borders in a complementary approach to the FDA. 

In most instances, the “states” have a “State Board”, frequently as a pharmacy board that includes medical devices, that sets standards for state-level licensure, permits, and enforcement. Further, the State Board conducts business, sets policy, and holds disciplinary hearings for pharmacists and pharmacies. These meetings are open to the public except when the Board Members are in closed session deliberating a decision for disciplinary action.

A Board Staff is employed to maintain permits and licenses, inspect pharmacies, and investigate situations that may be violations of the state Pharmacy Practice Act or laws governing the distribution of drugs.

 

CFR Compliance LLC™ assists companies and pharmacies with state-level requirements. Some of our services:

​

• New License Applications (all US 50 states and territories)

• Change of Designated Representative

• License Type and Addition of Controlled Substances

• Change of Ownership or Facility Address

• Notice of New Disciplinary Action/Status to all Boards

• Notice of past, previously undisclosed disciplinary actions to all Boards

• Withdrawal of any license or permit

• Coordination of the VAWD accreditation application process

• Verification of Licensure Project

• Yearly Reporting to FDA under DQSA, per facility

• Authentication of vendors, Ship-to Locations

 

​