article thumbnail

The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law Blog

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. See 21 U.S.C. Section II at 2.

article thumbnail

From Surgeries To Keeping Company: The Place Of Robots In Healthcare

The Medical Futurist

Assisting surgeries, disinfecting rooms, dispensing medication, keeping company: believe it or not these are the tasks medical robots will soon undertake in hospitals, pharmacies, or your nearest doctor’s office. Instead of a human, however, they used a mannequin designed for medical training.

article thumbnail

Hospital-at-Home: Bruce Leff and Tacara Soones

GeriPal

And we then did a bunch of work to develop medical criteria, to choose the right patients for hospital-at-home. And now, that has been expanded even further, as programs get more competent, and have better ability to keep eyes on the patient, and know what’s going on, and coordinate the logistics and supply chain to support the model.

Hospital 115