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HomeBusiness and Professions CodeDiv. 2Ch. 9Art. 7.5§ 4127 Sterile Compounding Pharmacy Licensing

§ 4127 Sterile Compounding Pharmacy Licensing

Business and Professions Code·California
AI Summary·Official Text·Key Terms·Related Statutes·References
AI SummaryVerified

§ 4127 Sterile Compounding Pharmacy Licensing

Key Takeaways

  • •If a pharmacy makes special sterile medicines (like IV bags or injections), they need a special license to do that.
  • •The state will make rules to make sure these pharmacies follow safety steps when making these medicines.
  • •If the big national rulebook for making sterile medicines changes, the state has 90 days to check if they need to update their own rules.

Example

A local pharmacy starts making special eye drops that need to be super clean so they don’t cause infections.

This pharmacy must get a special license to make these eye drops. The state will have rules to make sure the pharmacy keeps everything clean and safe. If the national safety rules for making clean medicines change, the state has to check and update their rules if needed.

AI-generated — May contain errors. Not legal advice. Always verify source.

Official Source
View on CA.gov

§ 4127 Sterile Compounding Pharmacy Licensing

(a) A pharmacy that compounds sterile drug products shall possess a sterile compounding pharmacy license as provided in this article. (b) The board shall adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines, and procedures to implement this article. (c) The board shall review any formal revision to General Chapter 797 of the United States Pharmacopeia and The National Formulary (USP–NF), relating to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary for the regulations adopted by the board pursuant to subdivision (b). (Amended by Stats. 2016, Ch. 484, Sec. 23. (SB 1193) Effective January 1, 2017.)

Last verified: January 22, 2026

Key Terms

sterile compounding pharmacy license.safetyregulationin californiaadministrative procedure actgeneral chapterunited states pharmacopeiathe national formulary

Related Statutes

  • § 4006 Drug Sale Restrictions
  • § 4021 Controlled Substance Definition
  • § 4052.03 Pharmacist Hiv Prophylaxis Authority
  • § 4110 Pharmacy Licensing Requirements
  • § 4126.8 Pharmacy Compounding Standards

References

  • Official text at leginfo.legislature.ca.gov
  • California Legislature. Business and Professions Code. Section 4127.
View Official Source