Clinic Manufacturing Provider Supply Chain 
The Medical Futurist
JUNE 17, 2025
Artificial intelligence Already, dentists employ software to get insights into clinical decision-making, but AI is changing the face of dentistry, just like it is in many other fields. Smart toothbrush While AI helps dental professionals provide better treatments, smart toothbrushes enable all of us to take better care of our teeth.
FDA Law Blog
JULY 5, 2023
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.
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My Green Doctor
MAY 3, 2025
The breadth of services provided by modern day medicine is profound. Dilating and anesthetic eye drops are used routinely to treat patients in most ophthalmology clinics. The standard of care worldwide in clinics is to use multidose eyedrop bottles — meaning there is enough medicine one bottle to treat many patients.
FDA Law Blog
OCTOBER 12, 2022
Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. Because naloxone is a prescription drug, its distribution is subject to the requirements of the Drug Supply Chain Security Act (DSCSA).
FDA Law Blog
MARCH 1, 2023
FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).
FDA Law Blog
APRIL 8, 2024
Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.
FDA Law Blog
SEPTEMBER 13, 2021
A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.
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