Stricter Standards for Compounding Facilities Take Effect

On Oct. 1, a new and stricter law relating to Florida’s compounding industry took effect. The law adds restrictions for compounding pharmacies and outsourcing facilities that ship medications to Florida. It also provides Florida’s Board of Pharmacy and Department of Health with additional oversight and power to penalize these companies, including the authority to inspect a pharmacy or sterile compounding facility.

The stricter rules also allow the Board of Pharmacy to discipline a nonresident pharmacy for conduct that causes, or could cause serious injury, without having to wait 180 days for the resident state to act. The Board is also authorized to discipline nonresident pharmacies and sterile compounding facilities for specified acts of noncompliance.

The stricter standards (Rule 64B16-27.797) follow a nationwide outbreak two years ago of fungal meningitis that was linked to contaminated drugs made by a compounding pharmacy in Massachusetts. About 17,000 vials of steroid injections were linked to the pharmacy causing more than 700 people to become ill and 64 to die.

That incident highlighted the potential vulnerabilities of the existing system and the need for more enforcement. The new law is designed to help Florida regulators better track incoming compounded medications.

The bill requires an out-of-state compounding pharmacy or an outsourcing facility to obtain a nonresident sterile compounding permit before being permitted to ship products to Florida. Non-resident pharmacies that are currently registered must be permitted by Feb. 28, 2015. However, all compounded sterile products shipped, mailed, delivered, or dispensed into Florida must meet state standards for sterile compounding.

These standards are intended to apply to all sterile pharmaceuticals, notwithstanding the location of the patient (e.g., home, hospital, nursing home, hospice, doctor’s office, or ambulatory infusion center).

Click here to read the new law.

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The Health Law Offices of Anthony C. Vitale