6/18/2015. USP <800> Update. USP <800> - What is it? What are HDs? John Voliva, R.Ph. Director of Legislative Relations PCCA

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1 USP <800> Update John Voliva, R.Ph. Director of Legislative Relations PCCA USP <800> - What is it? Proposed Chapter Published April 2014, Revised and Re-Published December 2014 Covers the handling of hazardous drugs (HDs) in healthcare settings include, but are not limited to pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians. Addresses: standards for handling hazardous drugs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations. What are HDs? <800> refers to the National Institute for Occupational Safety and Health (NIOSH) for the list of antineoplastic and other HDs used in healthcare. Includes: Antineoplastics like anastrozole, bleomycin, carboplatin, vincristine, etc. Other drugs included: clonazepam, colchicine, DES, estradiol, estrogens, hcg, progestins (inc. progesterone, androgens (inc. testosterone), risperidone, tacrolimus, etc. 1

2 NIOSH 2014 Major revision in September 2014 Split the list into three categories: Antineoplastic drugs Non-antineoplastic drugs apomorphine, carbamazepine, spironolactone Drugs with adverse reproductive effects clonazepam, colchicine, fluconazole Why is USP <800> needed? to protect personnel and the environment when handling HDs Helps bring overall USP guidelines up to speed with OSHA regulations <800> address containment of HDs <795> & <797> address quality of compounding non-sterile and sterile preparations Changes in revision Removed no acceptable level of HDs. Clarified: HDs may be unpacked in neutral / normal or negative pressure. Allowance for redundant HEPA filtration for primary engineering controls Allows for final antineoplastic dosage forms that are not manipulated other than counting do not need to be contained 2

3 Designated areas for: Receipt & unpacking of antineoplastic HDs or HD API Storage of HDs Nonsterile HD compounding Sterile HD compounding At a minimum, any facility simply handling HDs, especially antineoplastics, must comply with parts of this chapter. Receipt Antineoplastic HDs and HD APIs must be unpacked in neutral/normal (non-positive) or negative air pressure area. Storage Not on floor Non-antineoplastic, reproductive risk only and final dosage forms of antineoplastic HDs may be stored with other inventory Storage BUT Antineoplastic HDs requiring manipulation other than counting and any HD API must be stored separately, in a manner preventing contamination and exposure, in a negative pressure room. Sterile HDs can be stored in the negative pressure buffer room, but nonsterile HDs cannot be stored in the same room. Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area. 3

4 C-PECs Containment Primary Biological Safety Cabinet, Containment Ventilated Enclosure, Compounding Aseptic Containment Isolator C-SECs Containment Secondary Room where the C-PEC is located Non-Sterile Compounding C-PEC (can be redundant HEPA filtered) in a C-SEC with twelve air changes per hour Sterile Compounding C-PEC (must be vented outside) in a C- SEC with twelve air changes per hour (unclassified compounding area) to thirty ACPH (ISO Class 7 buffer room). Note on CSTDs: CSTD must not be used as a substitute for a C-PEC. CSTD should be used when allowed. CSTD must be used when administering when allowed. Other Considerations Gloves ASTM-tested chemotherapy gloves required when unpacking & compounding HDs and when administering antineoplastic HDs Dedicated gowns for HD compounding and when administering injectable antineoplastic HDs Eye & face protection required for compounding NIOSH-certified N96 respirators required for compounding Half mask with a multi-gas cartridge and P100 filter required if unpacking HDs not contained in plastic. Disposal of HDs and personal protective equipment (PPE) Hazard communication program Documented personnel training 4

5 Other Considerations SOPs for: Labeling, Packaging, Transport, Dispensing & Administering Cleaning All areas where HDs are handled and all reusable equipment and devices must be routinely deactivated / decontaminated and cleaned. SOP & documentation required Medical surveillance & follow up plan required. Issues with USP <800> Sub <1000> chapter in USP = enforceable 503A: compounding must comply with.the United States Pharmacopoeia chapter on pharmacy compounding In <800>, compound appears 228 times, compounding appears 194 times Would <800> be automatically enforceable by FDA? If pharmacy was found not in compliance with <800>, compounded products could be found misbranded and/or adulterated. Issues with USP <800> While <800> mimics many organizations published best practices, enforceability would be new. Cost estimates range from $15K - $100K for new build out, depending on size, current HVAC system, etc. 5

6 Websites USP <800>: NIOSH Hazardous Drug List: /pdfs/ pdf USP Background Compounding Expert Committee Part of the Council of Experts New Committee elected every 5 years USP <800> Sub-committee USP Background New or revised chapters undergo a public comment period 1 st version of <800> received the second most comments 2 nd version comment period closed

7 USP Background Subcommittee will review comments From there, one of three options: Revise & full committee vote Revise & Republish Cancel the chapter <800> Going Forward New compounding committee will be selected Changes to <800> subcommittee? Next full meeting of committee is in October 2015 Possible change to regular timeline of publish / enforceability <800> Going Forward Bottom line: Earliest enforceability date for USP <800> is August 1 st,