Thursday, June 29, 2023

 

 

A healthcare fraud of nearly $2 billion was traced back to one company's leadership team

Story by Ananya Bhattacharya • 8h ago

Tuesday, June 27, 2023

 

Compounding SIG Meeting

5 days ago — Agenda. Discussion of Semaglutide; Discussion of new compounding regulations ... Pharmacy-Based Immunization Administration by Pharmacy Technicians ...

 

Jenks man admits guilt in illegal compounding pharmacy ...

53 minutes ago — ... to induce doctors to steer patients to buy expensive compounding drugs from pharmacies controlled by him and another man, according to court records.

 

Chapter 3, Article 5 3.5.24, Handling of National Institute for ...

4 days ago — Sterile hazardous drugs shall only be compounded by pharmacies with appropriate licensure from the California State Board of Pharmacy. (b) Purpose.

 

The Health Lawyer - June 2023

1 day ago — Compounded drugs are not Food and Drug Administration (FDA)-approved. Accordingly, the FDA does not verify an individual compounded drug's safety and ...

 

Prohibition on Wholesaling Under Section 503B of the ...

9 hours ago — entity other than the outsourcing facility that compounded such drug. ... drugs compounded in compliance with section 503B of the FD&C Act are not exempt ..

 

Understanding and responding to the FDA's draft guidance ...

6 days ago — In October 2021, the Food and Drug Administration (FDA) issued new draft guidance for compounding drugs in hospitals and health systems.

FDA Announces Draft Guidance on Prohibitions of Compounded Drug Wholesaling

 

FDA Announces Draft Guidance on Prohibitions of Compounded Drug Wholesaling 


Today, FDA announced the availability of a draft guidance, 
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Actthat, if finalized, will describe how FDA intends to apply section 503B’s wholesaling provision to outsourcing facilities that compound drugs. The statutory prohibition on wholesaling helps to ensure that compounding is based on patient need, which, in turn, reduces the overall risk of patient harm and helps to preserve the integrity of the U.S. drug approval process and of the U.S. drug supply chain.   

One condition for an outsourcing facility to compound a drug under section 503B is that the drug will not be sold or transferred by an entity other than the outsourcing facility that compounded the drug. However, this wholesaling provision does not prohibit administration of a drug in a health care setting or dispensing a drug to a patient with a valid prescription. This prohibition preserves important distinctions between outsourcing facilities, which are intended to compound drugs for patients whose medical needs cannot be met by approved drugs, from conventional manufacturers, which generally engage in mass manufacturing of FDA-approved drug products.  

Compounded drugs are not FDA-approved and have not been reviewed by the agency for safety, effectiveness, or quality before they are marketed.  


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Thursday, June 22, 2023

 

What Lizzie's Law Means for Your Veterinary Practice

Jun 2, 2023 — In 2018, California passed a new pet medication compliance law known as Lizzie's Law, and the law could have far-reaching effects on veterinary practices ...

 

Rx soon needed for more antimicrobial veterinary drugs

May 25, 2023 — The change from OTC to Rx status isn't mandated by the government but was agreed to by drugmakers. The FDA has been working since 2012 to tighten oversight of ...

 

FDA Roundup: June 13, 2023

Jun 12, 2023 — As a result, all products affected by GFI #263 that enter the marketplace will now have prescription labels. Animal owners and caretakers will still have ...

 

FDA Guidance for Industry No. 263: Impact on Over-the ...

May 31, 2023 — Beginning June 11, 2023, medically important antibiotics that are currently available over the counter (OTC) will require a veterinarian's prescription.