Compliance, Regulatory & Quality Professionals

While the FDA regulates and oversees the manufacturing and distribution of drugs and other healthcare products within the U.S. stream of commerce, some states have established their own regulations to complement federal oversight.

Typically, states have a "State Board," often a pharmacy board, that sets standards for state-level licensure, permits, and enforcement related to medical devices and pharmaceuticals. This board conducts business, sets policy, and holds disciplinary hearings for pharmacists and pharmacies. These meetings are generally open to the public, except during closed sessions for deliberating disciplinary actions.

The Board Staff is responsible for maintaining permits and licenses, inspecting pharmacies, and investigating potential violations of the state Pharmacy Practice Act or laws governing drug distribution.

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

 

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