Wednesday, March 29, 2023

Footnote in FTC order address compounded medications used in racehorses-has to be compliant with Animal Medicinal Drug Use Clarification Act (AMDUCA) and the FDA Guidance for Industry (GFI) #256

Anti-Doping and Medication Control (ADMC) Program became effective March 27, 2023.

https://www.federalregister.gov/documents/2023/01/26/2023-00957/hisa-anti-doping-and-medication-control-rule


8 Proposed Rule 4111 (“S0 Non-approved Substances”) states: “Any pharmacological substance that (i) is not addressed by Rules 4112 through 4117 [other categories of banned substances], (ii) has no current approval by any governmental regulatory health authority for veterinary or human use, and (iii) is not universally recognized by veterinary regulatory authorities as a valid veterinary use, is prohibited at all times. For the avoidance of doubt, compounded products compliant with the Animal Medicinal Drug Use Clarification Act (AMDUCA) and the FDA Guidance for Industry (GFI) #256 (also known as Compounding Animal Drugs from Bulk Drug Substances) are not prohibited under this section S0.” Notice, 88 Fed. Reg. at 5122

 

Connecticut Compounding Conference

4 days ago — USP 795 Update: What's New with Non-Sterile Compounding? Richard Kiley, PharmD, Supervisor, Dispensing Operations, Outpatient Pharmacy Services, Yale New Haven ...

 

FDA Issues Compounding Guidance to Ease Hospital ...

6 days ago — In light of record high demand and ongoing supply challenges for pediatric fever-reducing medications, the FDA has issued immediate guidance on compounding ...

 

April 13, 2023Individuals may participate via WebEx. WebEx information will be provided on meeting agenda once released.   
March 23, 2023
Webcast Part 1

March 23, 2023
Webcast Part 2

Individuals may participate in person or via WebEx.

In person participation:

California State Board of Pharmacy
1625 N. Market Blvd.
1st Floor Hearing Room
Sacramento, CA 95834

Remote participation:

WebEx information is provided on the meeting agenda.

3/23/23 Agenda

3/23/23 Meeting Materials

3/23/23 Additional Meeting Materials 1

3/23/23 Additional Meeting Materials 2

3/23/23 Additional Meeting Materials 3

3/23/23 Additional Meeting Materials 4

3/23/23 Additional Meeting Materials 5

3/23/23 Additional Meeting Materials 6

 
February 15, 2023
Webcast
Individuals may participate in person or via WebEx.

In person participation:

California State Board of Pharmacy
1625 N. Market Blvd.
1st Floor Hearing Room
Sacramento, CA 95834

Remote participation:

WebEx information is provided on the meeting agenda.

2/15/23 Agenda2/15/23 Meeting Materials
Updated 2/17/23

2/15/23 Additional Meeting Materials 1

2/15/23 Additional Meeting Materials 2

2/15/23 Additional Meeting Materials 3

2/15/23 Additional Meeting Materials 4

2/15/23 Additional Meeting Materials 5

2/15/23 Additional Meeting Materials 6

 
January 23, 2023
Webcast
Individuals may participate via WebEx. WebEx information will be provided on meeting agenda once released.1/23/23 Agenda1/23/23 Meeting Materials

Additional Meeting Materials

Updated Enforcement Stats

1/23/23 Minute

Kudos to California Board of Pharmacy for disciplinary and enforcement action: See The Script January 2023

 January 2023 The Script (ca.gov)

California Board of Pharmacy 

 

March 23, 2023

7 days ago — RE: Proposed Changes to Regulations Related to Pharmaceutical Compounding of. Sterile Preparations. Dear Ms. Serpa: The American Pharmacists Association's ..