• 1.

    United States Pharmacopeial Convention (USP). Compounding Compendium. Rockville, MD: USP; 2020.

  • 2.

    United States Pharmacopeial Convention (USP). USP general chapter <795> pharmaceutical compounding—nonsterile preparations. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 3.

    United States Pharmacopeial Convention (USP). USP general chapter <797> pharmaceutical compounding—sterile preparations. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 4.

    United States Pharmacopeial Convention (USP). USP general chapter <800> hazardous drugs—handling in healthcare settings. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 5.

    United States Pharmacopeial Convention (USP). USP general chapter <825> radiopharmaceuticals—preparation, compounding, dispensing, and repackaging. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 6.

    United States Pharmacopeial Convention (USP). USP general chapter <797> pharmaceutical compounding—sterile preparations. In: USP 42−NF 37. Second Supplement. Rockville, MD: USP; 2019.

    • Search Google Scholar
    • Export Citation
  • 7.

    Newton DW. United States Pharmacopeia chapter <797> timeline 1989 to 2013. Int J Pharm Compd. 2013; 17:283-8.

  • 8.

    US Food and Drug Administration. Repackaging of certain human drug products by pharmacies and outsourcing facilities, 2017. www.fda.gov/downloads/Drugs/Guidances/UCM434174.pdf (accessed 2020 May 22).

    • Search Google Scholar
    • Export Citation
  • 9.

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

  • 10.

    United States Pharmacopeial Convention (USP). USP general chapter <1168> compounding for phase 1 investigational studies. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 11.

    US 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, 2018. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510154.pdf (accessed 2020 May 22).

    • Search Google Scholar
    • Export Citation
  • 12.

    American Society of Health-System Pharmacists. ASHP sterile products preparation certificate program, 2019. www.ashp.org (accessed 2020 May 22).

    • Search Google Scholar
    • Export Citation
  • 13.

    CriticalPoint, LLC. Website. www.criticalpoint.info (accessed 2020 May 22).

  • 14.

    Board of Pharmacy Specialties. BPS board certified sterile compounding pharmacist (BCSCP). www.bpsweb.org (accessed 2020 May 22).

  • 15.

    Pharmacy Technician Certification Board. Certified compounded sterile preparation technician™ program. www.ptcb.org/about-ptcb/news-room/whats-new-at-ptcb/2017/12/06/ptcb-launches-certified-compounded-sterile-preparation-technician-(cspt-)-program (accessed 2020 May 22).

  • 16.

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

    • Search Google Scholar
    • Export Citation
  • 17.

    American Society of Health-System Pharmacists (ASHP). ASHP’s Pharmacy Competency Assessment Center. Bethesda, MD: ASHP; 2019.

  • 18.

    United States Department of Labor, Occupational Safety and Health Administration. Hazard communication. www.osha.gov/dsg/hazcom/HCSFinalRegTxt.html (accessed 2020 May 22).

  • 19.

    Centers for Disease and Control Prevention. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Publication number 2016-161. www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf (accessed 2020 May 22).

    • Search Google Scholar
    • Export Citation
  • 20.

    United States Department of Labor, Occupational Safety and Health Administration. Hazard communication: small entity compliance guide for employers that use hazardous chemicals. www.osha.gov/Publications/OSHA3695.pdf (accessed 2020 May 22).

  • 21.

    Centers for Disease Control and Prevention. Hand hygiene in healthcare settings. www.cdc.gov/handhygiene (accessed 2020 May 22).

  • 22.

    ASTM International. ASTM D6978 standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs. www.astm.org/Standards/D6978.htm (accessed 2020 May 22).

  • 23.

    ASTM F739-12e1. Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact. West Conshohocken, PA: ASTM International.

  • 24.

    Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. The national personal protective technology laboratory, respirator trusted-source information. www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource.html (accessed 2020 May 22).

  • 25.

    Centers for Disease Control and Prevention. Safe injection practices to prevent transmission of infections to patients. www.cdc.gov/injectionsafety/ip07_standardprecaution.html (accessed 2020 May 22).

  • 26.

    Association for Professionals in Infection Control and Epidemiology. APIC position paper: safe injection, infusion, and medication vial practices in health care (2016). www.apic.org/Resource_/TinyMceFileManager/Position_Statements/2016APICSIPPositionPaper.pdf (accessed 2020 May 22).

    • Search Google Scholar
    • Export Citation
  • 27.

    Buchanan C, Schneider P, Forrey R. Compounding Sterile Preparations. 4th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2017.

    • Search Google Scholar
    • Export Citation
  • 28.

    United States Pharmacopeial Convention (USP) general chapter <71> sterility tests. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 29.

    US Food and Drug Administration. FD&C Act provisions that apply to human drug compounding. www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm606955.htm (accessed 2020 May 22).

  • 30.

    United States Pharmacopeial Convention (USP). USP general chapter <1231> water for pharmaceutical purposes. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 31.

    Controlled Environment Testing Association. CETA application guides. www.cetainternational.org (accessed 2020 May 22).

  • 32.

    Institute for Safe Medication Practices. Guidelines for safe preparation of compounded sterile preparations. www.ismp.org/guidelines/sterile-compounding (accessed 2020 May 22).

  • 33.

    United States Pharmacopeial Convention (USP). USP general chapter <659> packaging and storage requirements. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 34.

    Rhoads R, Exner L, Wagner JT. Demystifying dynamic smoke pattern tests for sterile compounding pharmacies. Am J Health-Syst Pharm. 2020;77:56-60.

    • Search Google Scholar
    • Export Citation
  • 35.

    US Food and Drug Administration. Bulk drug substances used in compounding under section 503a of the FD&C Act. www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm614204.htm (accessed 2020 May 22).

  • 36.

    US Food and Drug Administration. Regulatory policy information. www.fda.gov/drugs/human-drug-compounding/regulatory-policy-information (accessed 2020 May 22).

  • 37.

    United States Pharmacopeial Convention (USP). USP general chapter <1178> good repackaging practices. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 38.

    American Society of Health-System Pharmacists. ASHP guidelines on compounding sterile preparations. Am J Health-Syst Pharm. 2014; 71:145-66.

    • Search Google Scholar
    • Export Citation
  • 39.

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

  • 40.

    Centers for Disease Control and Prevention. Biosafety in microbiological and biomedical laboratories (BMBL). 5th ed. www.cdc.gov/labs/BMBL.html (accessed 2020 May 22).

  • 41.

    International Journal of Pharmaceutical Compounding. Website. www.ijpc.com (accessed 2020 May 22).

  • 42.

    Centers for Disease Control and Prevention. Guidelines for the prevention of intravascular catheter-related infections. www.cdc.gov/mmwr/preview/mmwrhtml/mm5132a9.htm (accessed 2020 May 22).

  • 43.

    American Society of Health-System Pharmacists (ASHP). Handbook on Injectable Drugs. 20th ed. Bethesda, MD: ASHP; 2018.

  • 44.

    Dellamorte Bing C, Nowobilski-Vasilios A. Extended Stability for Parenteral Drugs. 6th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2017.

    • Search Google Scholar
    • Export Citation
  • 45.

    King Guide Publications, Inc. King Guide to Parenteral Admixtures. Napa, CA: King Guide Publications; 2019.

  • 46.

    US Food and Drug Administration. MedWatch: the FDA safety information and adverse event reporting program. www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program (accessed 2020 May 22).

  • 47.

    United States Pharmacopeial Convention (USP). USP general chapter <1113> microbial characterization, identification, and strain typing. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 48.

    United States Pharmacopeial Convention (USP). USP general chapter <1163> quality assurance in pharmaceutical compounding. In: USP 43−NF 38 as of June 1, 2020. Rockville, MD: USP; 2020.

    • Search Google Scholar
    • Export Citation
  • 49.

    US Food and Drug Administration. Insanitary conditions at compounding facilities. www.fda.gov/media/124948/download (accessed 2020 May 22).

9. Personnel Training and Competence Documentation

in The Sterile Compounding Answer Book
Restricted access