• 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.

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