California Healthcare and Pharmaceutical Licensing

Pharmacy License Application

$750

Minimum 45 days

• The board will ONLY discuss the status of this application with the person identified as the contact person and any person who has signed the application as an officer, partner, member, and/or owner of the applicant business.
• Any application not completed within 60 days after being notified by the board of deficiencies may be deemed to have been abandoned, and the applicant may be required to file a new application and meet all the requirements which are in effect at the time of application. Fees applied to the application are not transferable and are not refundable.
• The Board may request additional documentation to confirm or substantiate the information in the application.
• This license requires different attachments, depending on the type of ownership. See specific guidelines for these classifications on the application form:
  • C1 Individually Owned
  • C2 Partnership
  • C3 Corporation (Not Publicly Traded)
  • C4 Publicly Traded Corporation
  • C5 Limited Liability Company
  • C6 Trust
  • C7 Government Owned (state, city, or county)
  • C8 Correctional Facilities (city or county-owned jail facilities)
  • C9 Native American Tribe
  • C10 Non-Native American Operating on Tribal Lands
• California Business and Professions Code section 4035 specifies “person" includes, but is not limited to, a firm, association, partnership, corporation, limited liability company, state governmental agency, trust, or political subdivision.
  • California Business and Professions Code section 4201(a) requires that “… the application shall state the information as to each person beneficially interested therein or any person with management or control over the license.”
  • The application must provide information to identify the ownership of the applicant's business. This may include multiple levels of ownership. The Board may require additional documentation to confirm or substantiate the reported ownership structure.

• Organizational Chart
  • Include a business ownership organizational chart that clearly documents the applicant’s business ownership structure. Include each level of ownership with the corresponding percentage of ownership to the top tier, percentages owned by all parties, and list the top five executive officers under the appropriate entity.
• Financial Affidavit in Support of Application (17A-2)
  • Complete and submit with original signatures.
  • Note: Not needed for a nonprofit organization, government, or tribal-owned.
• Approved Wholesale Credit Application or Wholesale Agreement
  • Submit a completed approved wholesale credit application/agreement.
  • Note: Not needed for a nonprofit organization, government, or tribal-owned.
• Lease Agreement/Grant Deed
  • Submit a copy of the signed lease agreement, including any amendments and/or extensions, or a copy of the grant deed.
  • A lease agreement should include language stating the landlord is complying with California Business and Professions Code section 4116 and Title 16, California Code of Regulations section 1714(d). If the lease does not include specific language regarding compliance with Pharmacy Law, please provide a written statement signed by both the landlord and tenant, that includes the following to demonstrate the landlord acknowledges California Pharmacy Law pertaining to is authorized to access the pharmacy. (Government-owned facilities, please submit a signed statement as described.)
    • 1. No person shall be permitted entry into a premise licensed by the Board of Pharmacy unless a registered pharmacist is present at all times pursuant to Business and Professions Code section 4116;
    • 2. Title 16, California Code of Regulations section 1714(d) provides that only a licensed pharmacist may have a key to an area where dangerous drugs and controlled substances are stored;
    • 3. No lease for a licensed premises may contain a provision inconsistent with Business and Professions Code section 4116 or Title 16, California Code of Regulations section 1714(d); and
    • 4. The landlord and tenant desire to clarify the lease with respect to Landlord’s ability to access
      the premises.
• Ownership information 
  • As outlined in Section C of the application
• Fingerprints
  • Each person who is required to complete a Certification of Personnel (as instructed in Section C) is required to complete the Live Scan or submit the Board-approved fingerprint cards for a criminal background check with the Department of Justice (DOJ) and Federal Bureau of Investigation (FBI).
  • If a person is currently associated with an active pharmacy license and has electronic fingerprints on file with the California State Board of Pharmacy, new fingerprints may not be required.

Application for Renewal of Pharmacy/Nonresident Pharmacy

$1034

Annually by the first day of the month of initial issuance

Correctional Clinic License Application

$620

$409

Annually by the first day of the month of initial issuance

Form CDPH 8595: Drug Manufacturing License Application: New Applicant, Ownership Change, Renewal, and Relocation

$4,187 application fee + $200 PDMA fee (if applicable).

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

$4,187 renewal fee + $200 PDMA fee (if applicable).

Biennially

Emergency Medical Services Automated Drug Delivery System (EMADDS) License Application

$150

$200

Annually by the first day of the month of initial issuance

A license renewal application will be emailed by the Board 60 days prior to the expiration date of the license.

Form HCS 200: Application for a Home Care Organization License

$5,603

Form HCS 200: Application for a Home Care Organization License

$5,603

Biennially

Home Medical Device Retailer Exemptee License: CDPH 8695

$403

Home Medical Device Retailer Exemptee License: CDPH 8695 (Renewal)

$242

Annually

Home Medical Device Retailer License Application: CDPH 8679

Mail

$1,509 base fee + $754 warehouse fee (if applicable)

Home Medical Device Retailer License Application: CDPH 8679 (Renewal)

Mail

$1,509 base fee + $754 warehouse fee (if applicable)

Annually by the registration anniversary date.

Home Medical Device Retailer License Application: CDPH 8679

$686

Home Medical Device Retailer License Application: CDPH 8679 (Renewal)

$686

Annually by the registration anniversary date.

Hospital In-Patient Sterile Compounding License Application

$3875

Request for Renewal of Sterile Compounding and Hospital-in-Patient Sterile Compounding Pharmacy License

$4085

Annually by the first day of the month of initial issuance

Hospital Pharmacy License Application

$750

Application for Renewal of a Hospital/Drug Room

$1034

Annually by the first day of the month of initial issuance

Hospital Satellite Compounding Pharmacy Application

$3875

$4085

Annually by the first day of the month of initial issuance

Hypodermic Syringes and Needles License Application

• $550 application fee
• $49 per individual fingerprint card fee

Request for Renewal of Hypodermic Needle & Syringe Permit

$400

Annually by the first day of the month of initial issuance

Form CDPH 8596: Medical Device Manufacturing Application: New Applicant, Ownership Change, Renewal, and Relocation

$4,187

Form CDPH 8596: Medical Device Manufacturing Application: New Applicant, Ownership Change, Renewal, and Relocation (Renewal)

$4,187

Biennially

Nonresident Outsourcing Facility License Application

$28500

Request for Renewal of Nonresident Outsourcing Facility License

$28500

Annually by the first day of the month of initial issuance

Nonresident Pharmacy License Application

$2427

• If you are doing business under a DBA or trade name, a fictitious name statement must be certified by the office of the county clerk in which it was filed
• Organizational Chart: Include a business ownership organizational chart that clearly documents the applicant’s business ownership structure. Include each level of ownership with a corresponding percentage of ownership to the top tier, percentages owned by all parties, and list the top five executive officers under the appropriate entity. If submitting a change of ownership application, include both the pre and post-closing organizational structures. 
• Ownership Information
  • A form is completed by each entity (person or company) in the ownership structure for the applicant business that is an Individual, Partner, Corporation, Limited Liability Company, Trust, Government, and Indian Tribe owned
  • If a parent/ grandparent company exists, organizational and ownership information may be required from the parent/ grandparent entity
  • Submit a business ownership organizational chart that clearly documents the applicant’s business ownership with the application. Include each level of ownership with the corresponding percentage of ownership to the top tier
• List of the top five officers, directors, members, managers, trustees, and/ or administrators and their licenses/ credentials
• List of top five largest owners or shareholders. The state may ask for a  full list. 
  • List the name of the stockholder, certificate number, percent of shares, dates issued and canceled, and the license number of each shareholder
  • List the name of the owner and the percent of ownership and license number for each owner
  • If no stockholders exist, list all “persons” with a beneficial interest or management or control of the license below. Under the heading "License Type" list any state professional or vocational licenses held - e.g., pharmacist, physician, podiatrist, dentist, veterinarian, etc. - and the license number if a natural person.  
  • Each person listed must sign the application
  •  
• Financial Affidavit in Support of Application
• Approved Wholesale Credit Application or Wholesale Agreement
• Lease Agreement/Grant Deed: Submit a copy of the signed lease agreement, including any amendments and/or extensions, or a copy of the grant deed. If the premises is leased, rented or occupied by any person who is licensed in California to prescribe, the prescriber must provide a signed statement stating if he/she has any beneficial interest or management or control over the license. 
• Pharmacy Inspection Report: Submit a copy of the last inspection report conducted by the home state regulatory agency
•  License Verification: (17M-17): Submit a license verification from the home state regulatory agency verifying the status of the pharmacy license
• Copy of License: Submit a copy of the home state-issued license
• A statement signed by either the PIC or a person with authority to bind the applicant business indicates that the pharmacy maintains records of controlled substances or dangerous devices dispensed to California patients, so those records are readily retrievable from other drugs dispensed
• Prescription Label: Submit one original prescription label that includes a toll-free number that meets the requirements as outlined in Business and Professions Code sections 4076 and 4076.5 and California Code of Regulation section 1707.5. (Note: Not required if the pharmacy is a call center and not dispensing any medications.) 
• Attach a list of pharmacists and their license numbers for those who fill prescriptions for California residents with a statement reflecting that a nonresident pharmacy shall not permit a pharmacist whose license has been revoked by the board to provide any pharmacy-related services to a person residing in California. The list needs to be signed by either the PIC or a person with authority to bind the applicant business
• The application shall provide information to identify the ownership of the applicant's business. This may include multiple levels of ownership. The Board may require additional documentation to confirm or substantiate the reported ownership structure
  • Corporations (Not Publicly Traded) submit the following:
    1. Ownership Information (17A-33): Complete the entire form and submit with original signatures.
       • Complete the entire form for each parent entity holding beneficial interest and/or management and control (one for each level of ownership up to the top tier), if applicable.
    2. Each corporate officer, major shareholder, and director submit:
       • Individual Personal Affidavit (17A-27) Not required for nonprofit
       • Certification of Personnel (17A-11)
       • Individual Financial Affidavit (17A-26) Not required for nonprofit or change of location.
    3. Articles of Incorporation: A copy filed with the Secretary of State for the applicant business bearing the Secretary of State’s stamp (proof of filing).
    4. Statement of Information (a or b):
    a) Submit a copy of the current filing with the Secretary of State bearing the Secretary of State’s stamp that discloses the current officers on file for the entity. OR
    b) Statement by Foreign Corporation endorsed by the California Secretary of State or equivalent governmental document (e.g. annual report) that discloses the current officer(s) on file for the entity. Required if the named corporation on the application is incorporated outside of California (If required by the California Secretary of State).
    5. Stock Certificates and Stock Ledger: Provide a copy of stock certificate(s) front and back (this includes canceled stock certificates) along with a copy of the stock ledger. If stocks are not issued, please provide a statement that states as such.
    6. Bylaws: Provide a copy of the bylaws or internal operating rules for the applicant business. (Redacted copies will not be accepted.)
  • Limited Liability Companies submit the following:
    1. Ownership Information (17A-33): Complete the entire form and submit with original signatures.
       • Complete the entire form for each parent entity holding beneficial interest and/or management and control (one for each level of ownership up to the top tier), if applicable.
    2. Each member/manager/executive officer submit:
       • Individual Personal Affidavit (17A-27) Not required for nonprofit
       • Certification of Personnel (17A-11)
       • Individual Financial Affidavit (17A-26) Not required for nonprofit or change of location.
    3. Articles of Organization: A copy filed with the Secretary of State for the applicant business.
    4. Statement of Information (a or b):
    c) Submit a copy of the current filing with the Secretary of State bearing the Secretary of State’s stamp that discloses the current officers on file for the entity. OR
    d) Statement by Foreign Corporation endorsed by the California Secretary of State or equivalent governmental document (e.g. annual report) that discloses the current officer(s) on file for the
    entity. Required if the named corporation on the application is incorporated outside of California (If required by the California Secretary of State).
    5. Operating Agreement: Current business operating agreement for the applicant business, including all exhibits and/or schedules. (Redacted copies will not be accepted.)  
  • Other entity types, refer to the application for specifics
• Fingerprint Requirements:
  • Each person who is required to complete a Certification of Personnel (as instructed in Section C) is required to complete the Live Scan or submit the Board approved fingerprint cards for a criminal background check with the Department of Justice (DOJ) and Federal Bureau of Investigation (FBI). If a person is currently associated with an active pharmacy license and has electronic fingerprints on file with the California State Board of Pharmacy, new fingerprints may not be required. 
  • ALL ownership types must complete the fingerprint requirement (Government-owned facilities are exempt from this requirement.). Business and Professions Code section 4201(a) requires “the application shall state the information as to each person beneficially interested or any person with management or control over the license.” With the addition of management or control over the license, officers/owners of nonprofit corporations will be required to have their fingerprints completed through the Department of Justice and Federal Bureau of Investigation. 
  • Fingerprint Instructions: Complete and attach ONE of the following (either A or B):
       • California residents must use Live Scan. Nonresidents can visit California to complete a Live Scan or submit fingerprints on cards supplied by the Board. The fingerprint cards must be processed at a location authorized to complete fingerprint cards for the DOJ/FBI (e.g. law enforcement agency) in the state the services are rendered.
       • DO NOT complete the Live Scan service or fingerprint cards until the applicant is ready to send in the application.
       • The Live Scan site may charge a processing fee separate from that payable to the Board. 
  • Fingerprint card processing fee is $49 per person ($32 DOJ and $17 FBI) made payable to the Board of Pharmacy.
       • The Board will accept fingerprint responses only from the California Department of Justice (DOJ) and the Federal Bureau of Investigation (FBI).
  • Specific instructions for California residents and non-resident individuals can be found on the application
• List ALL states/territories in which the applicant business is or has been licensed as a wholesaler, pharmacy, third-party logistics provider, manufacturer, re-packager, or outsourcing facility
• If there has been any disciplinary action taken against any of the licenses held by the organization, a written explanation giving full details of the action taken MUST be provided with the application
• Required signatures: 
  • Original ink signatures are required
  • All owners, partners, members, officers, directors, managers, or trustees of the applicant pharmacy named in the foregoing application, is duly authorized to make this application on its behalf and must be at least 18 years of age
  •  

• Approved Wholesale Credit Application or Wholesale Agreement
• Organizational chart
• Financial affidavit in support of application
• Lease Agreement/Grant Deed
• Pharmacy Inspection Report
• License Verification
• Copy of home state License
• PIC statement of records maintenance
• Prescription Label
• List of pharmacists
• Nonresident Pharmacy Ownership Documents (detailed in the application)

Application for Renewal of Pharmacy/Nonresident Pharmacy

$1034

Annually by the first day of the month of initial issuance

Application for Nonresident Pharmacy Sterile Compouding License

$8500

Request for Renewal of Sterile Compounding and Hospital-in-Patient Sterile Compounding Pharmacy License

$8500

Annually by the first day of the month of initial issuance

Nonresident Third-Party Logistics Provider License Application

$1000

Request for Renewal of Third-Party Logistics Provider/ Nonresident Third-Party Logistics Provider License

$1009

Annually by the first day of the month of initial issuance

Nonresident Wholesaler License Application

$1000

Application for Renewal of Wholesaler/Nonresident Wholesaler License

$1009

Annually by the first day of the month of initial issuance

Out-of-State Home Medical Device Retailer Registration: CDPH 8679

$242

Out-of-State Home Medical Device Retailer Registration: CDPH 8679 (Renewal)

$242

Annually by the registration anniversary date.

Outsourcing Facility License Application

$25,000

Request for Renewal of Outsourcing Facility License

$25,000

Annually by the first day of the month of initial issuance

Sterile Compounding License Application

$3875

Request for Renewal of Sterile Compounding and Hospital-in-Patient Sterile Compounding Pharmacy License

$4085

Annually by the first day of the month of initial issuance

Initial Treatment Provider Application (DHCS 6002)

Mail

$4220 initial outpatient certification application fee + $5470 initial biennial outpatient certification fee

• Articles of Incorporation, Partnership Agreement, or Sole Proprietor documents as applicable
• 501(c)(3) filing from California SOS, if applicable
• Fictitious Business Name Statement of Business License (sole proprietors only)
• Sole Proprietor Supplement
• Lease agreement, donated space agreement, or letter from school approving use of space
• Fire Clearance Certificate
• Zoning Clearance Certificate

Request for License/Certification Extenstion (DHCS 5999)

Mail

$5470 biennial outpatient certification extension fee

Licenses expire biennially by the last day of the month of initial certification. Renewal applications, documents, and fees are due to the department 120 days prior to the expiration date of the certification. For example, if your certification expires on 10/31 then your documents and renewal fees are due by 07/03.

• DHCS 5050 - Facility Staffing Data
• DHCS 5086 - Weekly Activities Section
• Fire Clearance
• Line Item Budget

Nonresident Pharmacy Application

$2427 application fee + $2000 temporary license fee

California Third-Party Logistics Provider License Application

$1000

Request for Renewal of Third-Party Logistics Provider/ Nonresident Third-Party Logistics Provider License

$1009

Annually by the first day of the month of initial issuance

California Veterinary Food-Animal Drug Retailer License Application

$610

Request for Renewal of Veterinary Food-Animal Drug Retailer Permit

$460

Annually

California Wholesaler License Application

$1000

Application for Renewal of Wholesaler/Nonresident Wholesaler License

$1009

Annually by the first day of the month of initial issuance