• 1.

    United States Pharmacopeial Convention. Compounding Compendium. Rockville, MD: United States Pharmacopeia; 2020.

  • 2.

    United States Pharmacopeial Convention. General chapter <795> pharmaceutical compounding—nonsterile preparations. USP 43−NF 38; 2020.

    • Search Google Scholar
    • Export Citation
  • 3.

    United States Pharmacopeial Convention. General chapter <797> pharmaceutical compounding—sterile preparations. USP 43−NF 38; 2020.

  • 4.

    United States Pharmacopeial Convention. General chapter <800> hazardous drugs—handling in healthcare settings. USP 43−NF 38; 2020.

  • 5.

    United States Pharmacopeial Convention. General chapter <795> pharmaceutical compounding—nonsterile preparations. USP 42−NF 37, second supplement; 2019.

    • Search Google Scholar
    • Export Citation
  • 6.

    United States Pharmacopeial Convention. General chapter <1178> good repackaging practices. USP 43–NF 38; 2020.

  • 7.

    United States Food and Drug Administration. Repackaging of certain human drug products by pharmacies and outsourcing facilities, 2017. https://www.fda.gov/downloads/Drugs/Guidances/UCM434174.pdf. Accessed May 17, 2020.

    • Search Google Scholar
    • Export Citation
  • 8.

    Kienle PC. The Chapter <800> Answer Book. Bethesda, MD: ASHP; 2017.

  • 9.

    United States Pharmacopeial Convention. General chapter <825> radiopharmaceuticals—preparation, compounding, dispensing, and repackaging. USP 43−NF 38; 2020.

    • Search Google Scholar
    • Export Citation
  • 10.

    United States Pharmacopeial Convention. General chapter <1168> compounding for phase 1 investigational studies. USP 43–NF 38; 2020.

  • 11.

    NIOSH List of antineoplastic and other hazardous drugs in healthcare settings, 2016. Publication number 2016-161. https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf?id=10.26616/NIOSHPUB2016161. Accessed May 17, 2020.

    • Search Google Scholar
    • Export Citation
  • 12.

    United States Food and Drug Administration. Compounded drug products that are essentially copies of a commercially available drug product under section 503a of the federal Food, Drug, and Cosmetic Act guidance for industry. 2018. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510154.pdf. Accessed May 17, 2020.

    • Search Google Scholar
    • Export Citation
  • 13.

    ASHP Sterile Products Preparation Certificate Program, 2019. www.ashp.org. Accessed Accessed May 17, 2020.

  • 14.

    CriticalPoint, LLC. www.criticalpoint.info. Accessed May 17, 2020.

  • 15.

    Board of Pharmacy Specialties. BPS Board Certified Sterile Compounding Pharmacist (BCSCP). www.bpsweb.org. Accessed May 17, 2020.

  • 16.

    Pharmacy Technician Certification Board. Certified Compounded Sterile Preparation Technician Program. https://www.ptcb.org/about-ptcb/news-room/whats-new-at-ptcb/2017/12/06/ptcb-launches-certified-compounded-sterile-preparation-technician-(cspt-)-program. Accessed May 17, 2020.

  • 17.

    Murdaugh LB. Competence Assessment Tools for Health-System Pharmacies. 5th ed. Bethesda, MD: ASHP; 2015.

  • 18.

    Hennenfent JA, Pace HA, eds. Pharmacy Competency Assessment Center. Bethesda, MD: ASHP; 2019.

  • 19.

    United States Department of Labor. Occupational Safety and Health Administration. HAZCOM 1994 program guidance. https://www.osha.gov/dsg/hazcom/solutions.html. Accessed May 17, 2020.

  • 20.

    United States Department of Labor. Occupational Safety and Health Administration. Hazard communication. https://www.osha.gov/dsg/hazcom/HCSFinalRegTxt.html. Accessed May 17, 2020.

  • 21.

    United States Department of Labor. Occupational Safety and Health Administration. Hazard communication: Small entity compliance guide for employers that use hazardous chemicals. https://www.osha.gov/Publications/OSHA3695.pdf. Accessed May 17, 2020.

  • 22.

    Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, The National Personal Protective Technology Laboratory. Respirator Trusted-Source Information. List of approved filtering facepiece respirators. http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource.html. Accessed May 17, 2020.

  • 23.

    Centers for Disease Control and Prevention, hand hygiene in healthcare settings. www.cdc.gov/handhygiene. Accessed May 17, 2020.

  • 24.

    United States Food and Drug Administration. FD&C Act provisions that apply to human drug compounding. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm606955.htm. Accessed May 17, 2020.

  • 25.

    United States Pharmacopeial Convention. General chapter <1231> water for pharmaceutical purposes. USP 43–NF 38; 2020.

  • 26.

    United States Pharmacopeial Convention. General chapter <41> balances. USP 43–NF 38; 2020.

  • 27.

    United States Pharmacopeial Convention. General chapter <1176> prescription balances and volumetric apparatus used in compounding. USP 43–NF 38; 2020.

    • Search Google Scholar
    • Export Citation
  • 28.

    United States Pharmacopeial Convention. General chapter <1251> weighing on an analytical balance. USP 43–NF 38; 2020.

  • 29.

    United States Food and Drug Administration. Bulk drug substances used in compounding under section 503a of the FD&C Act. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm614204.htm. Accessed May 17, 2020.

  • 30.

    ASHP. ASHP technical assistance bulletin on compounding nonsterile products in pharmacies. Am J Hosp Pharm. 1994;51:1441-1448.

  • 31.

    International Journal of Pharmaceutical Compounding. www.ijpc.org. Accessed May 17, 2020.

  • 32.

    Allen LV, Bassani GS, Edmund J, et al. Strength and stability testing for compounded preparations. United States Pharmacopeial Convention. https://www.usp.org/sites/default/files/usp/document/FAQs/strength-stability-testing-compounded-preparations.pdf. Accessed May 17, 2020.

  • 33.

    United States Pharmacopeial Convention. General chapter <51> antimicrobial effectiveness testing. USP 43–NF 38; 2020.

  • 34.

    United States Pharmacopeial Convention. General chapter <659> packaging and storage requirements. USP 43–NF 38; 2020.

  • 35.

    United States Pharmacopeial Convention. General chapter <1112> application of water activity determination for nonsterile pharmaceutical products. USP 43–NF 38; 2020.

    • Search Google Scholar
    • Export Citation
  • 36.

    Power LA, Coyne JW. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2018;75:1996-2031.

  • 37.

    United States Pharmacopeial Convention. General chapter <1163> quality assurance in pharmaceutical compounding. USP 43–NF 38; 2020.

1. USP <795> Availability

in The Nonsterile Compounding Answer Book
DOI:
https://doi.org/10.37573/9781585286782.001
Free access

  • 1.1 Where can I find the full text of USP <795>?

  •    USP publishes the USP Compounding Compendium.1 It contains all the major compounding chapters: <795> Pharmaceutical Compounding—Nonsterile Preparations,2 <797> Pharmaceutical Compounding—Sterile Preparations,3 and <800> Hazardous Drugs—Handling in Healthcare Settings4 as well as all the other chapters that are referenced in those three core compounding chapters. Additionally, the General Notices that apply to compounding and compounding monographs are included. The Compounding Compendium is available through USP at www.usp.org as an annual subscription.

  •    Your subscription allows you to download updates throughout your subscription year. Be sure to do that each February, June, and November so you have the most current versions of existing chapters and any new General Notices, General Chapters, or monographs that were completed in the prior months.

  • 1.2 When did USP <795> become official?

  •    USP <795> has been an official standard since 2004. It was previously revised in 2011 when USP <1075> Good Compounding Practices was incorporated into it and in 2014 to clarify the distinction between beyond-use dating of nonsterile and sterile preparations. A proposed revision was published in 2019 but was appealed and returned to the USP Compounding Expert Committee to evaluate and/or revise.5

  • 1.3 Is USP <795> a guideline? A requirement?

  •    USP<795> is a minimum standard. Regulators such as federal or state entities can make it a regulation by including it in their documents. Accreditation organizations such as The Joint Commission, DNV-GL Healthcare, the Pharmacy Compounding Accreditation Boards, and others can include it in their own standards.