California Application For Nonresident Pharmacy Sterile Compounding License

State:
California
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CA-SKU-4732
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Application For Nonresident Pharmacy Sterile Compounding License

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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.

Federal law addresses compounding by a licensed pharmacist in a state-licensed pharmacy, or federal facility, or by a physician, as well as compounding by or under the direct supervision of a licensed pharmacist in an outsourcing facility.

A pharmacist practicing in a nonresident pharmacy is NOT required to hold a California pharmacist license. The nonresident pharmacy must have a pharmacist-in-charge who is responsible for ensuring that the pharmacy complies with all California requirements for medications dispensed or shipped to California patients.

(e) A drug preparation shall not be compounded until the pharmacy has first prepared a written master formula document that includes at least the following elements: (1) Active ingredients to be used. (2) Equipment to be used.

Compounded medications are ordered by a licensed physician, nurse practitioner, veterinarian or other prescriber, and mixed by licensed compounding pharmacists in a safe and carefully controlled environment.

The practice of compounding is regulated by state boards of pharmacy. Community and hospital compounding pharmacists are allowed exemptions to the Federal Food, Drug, and Cosmetic Act of 1938 if they comply with the regulations outlined in Section 503A.

Governor Jerry Brown of California signed a new law (SB 294) that requires sterile compounding pharmacies to obtain additional licensure from the California State Board of Pharmacy before compounding or dispensing sterile drug products, or before shipping these products into the state.

sterile compounding is defined as the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer's labeling, or otherwise altering a drug or bulk drug substance to create a nonsterile preparation (adapted from the latest draft of USP <795>).

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California Application For Nonresident Pharmacy Sterile Compounding License