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California Application For A Sterile Compounding Pharmacy License Packet

State:
California
Control #:
CA-SKU-4731
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PDF
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Application For A Sterile Compounding Pharmacy License Packet

The California Application For A Sterile Compounding Pharmacy License Packet is a comprehensive set of documents that must be submitted to the Board of Pharmacy in order to obtain a sterile compounding pharmacy license. It includes the following documents: 1. Application for a Sterile Compounding Pharmacy License; 2. Business and Professions Code Section 4022.6 Declaration Form; 3. Pharmacist Qualifying for Sterile Compounding Declaration Form; 4. Sterile Compounding Pharmacy Policy and Procedure Manual; 5. Pharmacy Hazard Analysis and Risk-Based Preventive Controls Plan; 6. Quality Assurance Program; 7. Pharmacy Site Inspection Report; 8. Controlled Substance Inventory Form; 9. Controlled Substance Registration and License Number; and 10. Fee and Supporting Documents. The packet must be submitted to the Board of Pharmacy for review and approval. Upon approval, a sterile compounding pharmacy license will be issued to the applicant.

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FAQ

You can register to take the NAPLEX online via . The fee is $465.00; effective Monday, , the fee will be $485.00. If you do not want to register online and if California is your primary state of taking the NAPLEX, you may request a scantron via e-mail to custserv@nabp.net.

Sterile compounding is the method of preparing custom medications for patients in a sterile environment to prevent contamination and ensure patient safety. Not all pharmacies offer this service, but those that do are called compounding pharmacies.

If another state is your Primary State: Licensure Transfer Application - If another state is your primary state for the NAPLEX and you are licensed in another state, you will need to request a licensure transfer application through the NABP.

A buffer area (or ?cleanroom?) is defined as an area where a PEC is located and where activities such as prepa- ration, compounding, and staging of CSPs occur.

The NAPLEX is a 6 hour exam composed of 225 questions that are delivered in a computerized, fixed form. The exam results will be reported as pass or fail, and candidates are allowed 5 attempts to pass the exam.

The majority of candidates will receive NAPLEX results around seven business days after taking their exam. Exam results are available in your NABP e-Profile for the majority of states. Waiting times may differ for candidates from states that do not participate in the NABP's online exam results interface.

To be licensed in California as a pharmacist, you must pass the North American Pharmacist Licensure Examination (NAPLEX) and the California Practice Standards and Jurisprudence Examination for Pharmacists (CPJE).

We can compound sterile ophthalmic drops, ointments, sprays, injections and pre-op solutions, including anesthetics, antibiotics, antioxidants, antivirals, cataract therapies, corticosteroids, ophthalmic decongestants, miotics, mydriatics, and lubricants.

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California Application For A Sterile Compounding Pharmacy License Packet