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Food and Drug Branch (FDB)

 FDB Home Page

 Contact

Main Telephone:

(800) 495-3232

 

Email:

FDBMedDevice@cdph.ca.gov

 

Address (Courier Delivery):

California Department of Public Health - Food and Drug Branch

1500 Capitol Ave, MS 7602

Sacramento, CA 95814

 

Address (Non-Courier Delivery):

California Department of Public Health - Food and Drug Branch

P.O. Box 997435, MS 7602

Sacramento, CA 95899

Drug Safety Program

The Drug Safety Program’s mission is to promote and improve the health and well-being of all California residents and to facilitate the growth and vitality of California drug, cosmetic, and other consumer product industries. This mission is accomplished by an integrated regulatory and science based program that utilizes education, investigation, and enforcement to assure that products are not adulterated, misbranded or falsely advertised.

The vision is to be recognized worldwide as a dynamic, scientifically based, accountable organization in partnership with all who seek the betterment of public health, by promoting the highest standards of safety, quality and technology for drugs, cosmetics, and related products.

 News and Updates

Drug Recalls

FDA Warning: FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks​

FDA Warning: FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection​

FDA Warning: Risk of Invasive Disease in Preterm Infants Given Probiotics Formulated to Contain Live Bacteria or Yeast​

FDA clarifies results of recent advisory committee meeting on oral phenylephrine​

FDA Opiod Update: Exemption and Exclusion FromCertain Requirements of the Drug Supply Chain Security Act for the Distributionof FDA-Approved Naloxone Products During the Opioid Public Health Emergency (PDF)

Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply 

Notice of Termination of the Temporary Registration for the Manufacturing of Alcohol Based Hand Sanitizer (PDF)

FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers

FDA Provides Policyfor Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, IncludingDuring COVID-19 Public Health Emergency - Drug Information Update

Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicine

Governor Newsom Signs Executive Order on Actions in Response to COVID-19 6.5.20

Executive Order N-68-20 (PDF)

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compound

 Certificates and Licenses

Drug License Fees (Effective July 1, 2022) (PDF)

Drug Manufacturing License Application: New Applicant, Ownership Change, Renewal, and Relocation  CDPH 8595 (DocuSign)

  • Please note:  For DocuSign applications, after fully completed, please print and remit with payment to the address on the instructions page of the application. We do not accept these electronically.

Human Prescription Drug Manufacture-Disclosure Statement: (CDPH 53) (PDF)

FDB License / Registration Verification Request Form: (CDPH 8707) (PDF)

 Covid-19 Updates

​​Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States (2023-2024)​

Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

FDA Authorizes NewMonoclonal Antibody for Treatment of COVID-19 that Retains Activity AgainstOmicron Variant (PDF)

Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults

Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19

Health Alert - FDA Warns that Getting Alcohol-Based Hand Sanitizer in the Eyes Can Cause Serious Injury

FDA Approves First Covid-19 Vaccine

Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (PDF)

Janssen COVID-19 Vaccine Emergency Use Authorization (EUA) of the Janssen COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 18 Years of Age and Older (PDF)

FDA Moderna COVID-19 Vaccine Fact Sheet for Recipients, Caregivers, and Healthcare Providers Administering Vaccine in Various Langauges

FDA Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers in Various Languages

CDC Health Advisory on Serious Adverse Health Events Associated with Methanol-based Hand Sanitizers (PDF)

FDA Warns Consumers of Risk of Methanol Contamination in Certain Hand Sanitizers

Coronavirus (COVID-19) Update: FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem

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