compounded medications | The Health Law Firm Blog

New Requirements Released for Physician Medical Records Related to Compounded Medications

By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On September 5, 2013, the Florida Board of Medicine and the Florida Board of Osteopathic Medicine published new requirements for medical record documentation related to compounded medications administered to patients in an office setting. These standards become effective September 9, 2013. The standards are contained in Florida Administrative Code Rules adopted by each board.

We believe the updated requirements are a result of the recent recalls of tainted compounded medications that have spread across the country and […]

By The Health Law Firm|2024-03-14T10:00:52-04:00June 1, 2018|Administrative law, Board of Medicine, In the Know, The Health Law Firm Blog|

New Permit Law for Florida Pharmacies that Compound Sterile Products

Lance O. Leider, J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Board of Pharmacy announced a new law which will be required for pharmacies that compound sterile products. Effective September 23, 2013, Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires most pharmacies that engage in the preparation of sterile compounded products in Florida to obtain a Special Sterile Compounding Permit. Pharmacies compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014.

Click here […]

By The Health Law Firm|2024-03-14T10:01:15-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Pharmacy, Pharmacy Law|

Out-of-State Compounding Pharmacies May Need a Permit To Do Business in Florida

By Lance O. Leider, J.D., The Health Law Firm

Beginning on October 1, 2014, out-of-state compounding pharmacies may be required to hold a compounded sterile product permit. That’s because the Regulated Industries Committee of the Florida Senate voted on March 13, 2014, to approve a bill increasing the restrictions on out-of-state compounding pharmacies that ship medications into Florida. These increased regulations would apply to around 300 compounding pharmacies shipping medicine to Florida.

The bill was introduced to increase standards for compounding pharmacies that create medications that are tailored to the needs of individual patients. Currently the bill is out for reference review. Considering that this is a hot issue in Florida […]

By The Health Law Firm|2024-03-14T10:01:16-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Pharmacy, Pharmacy Law|

Florida Toughens Up Drug Compounding Law for Out-of-State Pharmacies

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A new, stricter law on Florida’s compounding pharmacy industry took effect October 1, 2014.
The new law increases the restrictions for out-of-state compounding pharmacies and outsourcing facilities that ship medications into Florida. The law also gives the Florida Board of Pharmacy and Florida Department of Health (DOH) more power to oversee and penalize these companies. Click here to read the new law.

The law was enacted to increase the standards for compounding pharmacies that create medications that are supposed to be tailored to the needs of individual patients. In an effort to prevent […]

By The Health Law Firm|2024-03-14T10:01:18-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Florida Legislature|