New CA Law - SB 294 Requires A Special License For Sterile Compounders

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Updated June 26, 2023:

The original link broke.

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Sterile Compounding/Nonresident Sterile Compounding/Hospital In-Patient Sterile Compounding Pharmacy/Hospital Satellite Compounding Pharmacy License - California State Board of Pharmacy

---  the original post follows below  ---

Governor Jerry Brown signed Senate Bill 294 into law. SB 294 will go into effect in July of 2014.

Highland News > Archives > News > Bill Increasing Oversight Of Sterile Compounding Pharmacies Signed Into Law:

"Specifically, SB 294 requires both in-state and out-of-state pharmacies that compound sterile drug products for California patients that will be inhaled, injected, or administered into the eye to apply for a special, additional license from the California State Board of Pharmacy. Under this new law, the board is required to inspect these facilities annually to provide consistent oversight and ensure compliance with pharmacy law."

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FDA Summary - 2013 Compounding Pharmacy Inspections

• California Board of Pharmacy Designated Representative Training Courses by SkillsPlus International Inc.  |  Board Approved  |  for wholesalers, 3PL, reverse distributors.  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

Updated Aug 28, 2020:

You might also be interested in this FDA webpage:  Human Drug Compounding - FDA.gov

or

this recent headline story:  Cardinal Health sued over alleged fraudulently obtained contracts - SeekingAlpha.com

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Pharmacy Compounding > Summary: 2013 FDA Pharmacy Inspection Assignment:

"The agency is currently evaluating the information obtained during the inspections and where applicable, will apply its existing legal authority to protect the public health. For the firms that are operating outside the bounds of traditional pharmacy compounding and who had significant sterile production issues, FDA plans to take aggressive action, including through enforcement actions, as appropriate."

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• California Board of Pharmacy Designated Representative Training Courses by SkillsPlus International Inc.  |  Board Approved  |  for wholesalers, 3PL, reverse distributors.  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

"The Politic" Interviews Margaret Hamburg (FDA)

• Respected FDA CGMP online training courses offered by SkillsPlus International Inc.

The Woman in Charge: Margaret Hamburg | The Politic:

". . . The Politic: Let’s move on to the recent meningitis outbreak. Was the FDA in this case supposed to have prevented the outbreak, or was the role of the FDA more in the response portion?

Sadly, the current regulatory framework for these so-called compounding pharmacies is inadequate and ambiguous as to the state role and the federal role, and we need to address that concern. I hope we can work with Congress to craft new legislation that will strengthen and clarify existing law. Within the existing legal framework, we are in a much more reactive posture rather than a preventive one.

As a public health official and the head of the FDA, I would really like to be able to see a system that could help us prevent this type of tragedy going forward. As we've seen the industry and healthcare system evolve, I think what has always been a concern about a lack of clarity between state and federal responsibilities has gotten more pronounced and more dangerous. More and more health care systems are relying on sort of hybrid  compounding pharmacy/manufacturer in order to produce products they need. These facilities are in a gray area in between state and FDA regulations. . . . "

'via Blog this'

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

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• CA Designated Representative Reverse Distributor Training  
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     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
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New CA Board of Pharmacy Compounding Laws - Effective April 1, 2013

Updated November 13, 2020

The link in the original post broke.

You might also be interested in:

Compounded Drug Preparations - Title 16, California Code of Regulations

Sections 1735.1, 1735.2, 1735.6, 1751.1, 1751.4 - Effective Date of Regulation: January 30, 2019 - Order of Adoption (Approved Regulation Text) (PDF)

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From the California Board of Pharmacy:

The board's rulemaking to amend Sections 1735.1, 1735.2, 1735.3 and 1751.2 related to compounding has been approved by the Office of Administrative Law. The regulation goes into effect on April 1, 2013. 

To view the regulation go to:
CA Board of Pharmacy - Regulations Approved in 2013 - Compounding Drug Products - for all related proceedings and documents

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

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ASHP's Sterile Compounding Checklist

Updated December 6, 2025

You might also be interested in:

• ASHP STERILE COMPOUNDING COMPETENCY LIBRARY
• Compounding Quality Center of Excellence On-demand Training - FDA.gov

= = =
Updated September 2, 2019

The link in the original post below is broken.  You might also be interested in:

• ASHP - Sterile Compounding Resource Center
• ASHP Guidelines on Outsourcing Sterile Compounding Services (2015 PDF)

= = = original post below = = =

The American Society of Health-System Pharmacists (ASHP) just published this document:
     Eight Critical Steps Related to Sterile Compounding Services - Member Action Check List

In the checklist, ASHP says:

"ASHP strongly encourages you to review this list, even if your pharmacy department does not have a contract with an external compounding facility. This is important because off-site clinics or affiliated entities within your health system may have developed independent contracts that the pharmacy department was not involved in securing."

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute