usp <800> hazardous drug list 2020

NIOSH response: Sublimation depends on the drug form and is not an inherent toxicity property of the drug. documents in the last year, 9 These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. daily Federal Register on FederalRegister.gov will remain an unofficial The manufacturer or any other stakeholder is invited to comment on the sufficiency of the explanation of the basis for adding a drug to the List. on FederalRegister.gov Learn more here. What structural or format changes could be made to improve the utility of this table? The following seven drugs that were proposed for placement on the List in the February 2018 FRN are no longer proposed for placement on the List, for the reasons discussed above in Sections II.B. November 02, 2020 USP 800 For Pharmacists & Healthcare Workers An Overview of USP 800 The U.S. Pharmacopeia Convention (USP) updated the General Chapter USP 800 on December 1, 2019 to set standards of handling hazardous drugs, specifically in clinical pharmacy settings. Employing this same train of thought to the draft policy and procedures, it would, in my opinion, be a best practice to add the drug that has insufficient information to the List until suitable scientific evidence demonstrates that it should not be included.. In order to clarify that the List is a hazard identification tool, NIOSH has removed this table from the document. In the 2016 List, Table 5 provided information on recommended exposure controls for hazardous drugs based on formulations. No labeling change has ever resulted in the removal of a drug from the List, but labeling changes that demonstrate a lack of evidence of toxicity would be dealt with in the regular List updates. 2. NIOSH response: The reviewer has interpreted the NIOSH statement differently than what the agency intended. NIOSH's findings about each drug are as follows: Comment: The hormonal agents in Table 1 of the 2016 List that are exclusively reproductive risks, including estrogens (estrogen agonist-antagonists such as tamoxifen and antiestrogens such as anastrozole, exemestane, and letrozole), gonadotropins (leuprolide and triptorelin), antigonadotrophins (degarelix), and progestins (megestrol) should be moved to Table 2 or 3. Accordingly, NIOSH proposes to place olaparib on the List. You will be subject to the destination website's privacy policy when you follow the link. Therefore, at this time NIOSH is no longer proposing to place the class of botulinum toxins on the 2020 List. The goal of the standard is to help protect health - care workers from the risks associated with handling hazardous drugs. Comment: Interferon beta-1b should not be placed on the List, or, in the alternative, it should only be placed on Table 3. Comment: Prior to USP <800>, the NIOSH List was considered a precautionary recommendation. But the USP <800> standards are too restrictive and overreaching, and the chapter's incorporation into state law places facilities at legal risk if they fail to comply. Register, and does not replace the official print version or the official Written comments, identified by CDC-2020-0046 and docket number NIOSH-233-C, may be submitted by any of the following methods: Persons with disabilities experiencing problems accessing this page should contact CDC-INFO at CDC-INFO email form: http://www.cdc.gov/info/, 800-232-4636 or the TTY number at (888) 232-6348 and ask for a 508 Accommodation PR#9342. USP <800> Public comment: Several commenters offered suggestions on the document's use of USP <800>. These changes now reflected in the draft Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (draft Procedures) include the clarification of some language and streamlining the procedures NIOSH uses to determine the hazard potential of a specific drug. In its place, NIOSH has developed a new, comprehensive document on risk management strategies entitled, Managing Hazardous Drug Exposures: Information for Healthcare Settings, which includes a revision of this table on control approaches to safe handling of hazardous drugs. More information and documentation can be found in our After evaluating public comments, NIOSH made the following determination: 13 drugs are proposed for placement on the List, 3 drugs are automatically added to the List because they have MSHI in the package insert (2 drugs identified in the 2018 FRN and another recently-approved by FDA), 7 drugs proposed for placement on the List in the 2018 FRN are no longer considered in this action. edition of the Federal Register. 1503 & 1507. Many of the drugs currently used to fight cancer function differently than those previously used. . NIOSH response: BCG, a vaccine approved by the FDA Center for Biologics Evaluation and Research, was included in the original 2004 Alert and `grandfathered' into the List. Use the PDF linked in the document sidebar for the official electronic format. This document has been published in the Federal Register. Document Drafting Handbook Fluconazole is included in the List on Table 3, but for two newer azole antifungals, the available information showed a toxic effect that does not meet the NIOSH definition of a hazardous drug (ketoconazole) and information does not demonstrate or support that the drug meets the NIOSH definition (itraconazole) in the FRN. Reproductive toxicity: The package insert contains MSHI stating, Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC and should not come into direct contact with the IMLYGIC injection sites, dressings, or body fluids of treated patients due to the risk of transmission of talimogene laherparepvec and herpetic infection. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a Federal Register notice. are not part of the published document itself. Comment: Exenatide should not be placed on the List. c. What information is redundant, incorrect, missing, or not needed? It would presumably be courteous to respond to any party that has provided comments for consideration.. NIOSH response: As presented in the 2018 FRN, daratumumab and dinutuximab were reviewed and did not meet the NIOSH criteria for a hazardous drug because the available information about each drug's toxicity was insufficient to support placement on the List. The documents posted on this site are XML renditions of published Federal documents in the last year, 29 Peer review comment: NIOSH should list further tools to aid employers to protect workers. ET on July 30, 2020 Two drugs included in the 2018 FRN, inotuzumab ozogamicin and trabectedin, have MSHI and are automatically added to the 2016 List. Only official editions of the The list was compiled from information provided by four institutions that had generated lists of haz- . 2020-09332 Filed 4-30-20; 8:45 am], updated on 4:15 PM on Monday, May 1, 2023, updated on 8:45 AM on Monday, May 1, 2023. better and aid in comparing the online edition to the print edition. documents in the last year, 83 NIOSH response: NIOSH reviews the relevant data on a drug when a label change is made, not just the data relating to the label change. NIOSH should provide the rationale for not proposing their placement on the List. . 9. In the February 2018 Request for Comment, NIOSH requested comment on a draft Policy and Procedures for developing the List. NIOSH will consider conducting a systematic review if such studies become available relating to the hazard that a specific drug may pose in healthcare settings. What changes could be made to improve the utility of the information? The only potential risk to healthcare workers is of an accidental needle stick, which would not inject a pharmacologically active dose. Accordingly, the monoclonal antibodies bevacizumab, blintumomab, and trastuzumab should not be placed on the List, and pertuzumab should be removed from Table 1. Not allowing public commenters to review peer reviews before submitting their own comments to the docket is in conflict with the principle of transparency established in the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664, Jan. 14, 2005). were derived. Because this issue is a matter of delivery form, rather than inherent toxicity, it is currently beyond the scope of the List. USP <800> incorporates by reference the NIOSH List and imposes certain requirements on its users when handling certain drugs on the List. NIOSH proposed an updated list in 2020, Ms. Kienle noted, which is not yet official. NIOSH created and periodically updates the List to assist employers in providing safe and healthful workplaces by offering a list of drugs that meet the NIOSH definition of a hazardous drug. . Animal data on the developmental effects of fluconazole suggest developmental changes in rats at doses less than the equivalent maximum human recommended dose of 400 mg/day. 4. 6. Section C of the draft Procedures, which includes the evaluation criteria, would be expanded to include new clauses 4 and 5 to allow NIOSH to consider additional factors beyond the intrinsic toxicity of the drug molecule in determining whether to place the drug on the List. Note: General Chapter <800> is informational and not compendially applicable. Register (ACFR) issues a regulation granting it official legal status. The drugs and rationales for each of them include the following: NIOSH response: Each of these drugs has either been previously reviewed and found not to meet the NIOSH definition of a hazardous drug, falls outside the scope of the List, or is slated for review in the future. Comment: The List seems to be heavily weighted toward older drugs.Start Printed Page 25444. Public comments on the draft Policy and Procedures and the drugs proposed for placement on the List and peer review summaries on specific drugs proposed for placement on the List are available in dockets CDC-2018-0004 and NIOSH-233-B. Most were concerned . As such, they should be moved from Table 1 to another place on the List. All three draft documents are available in the docket for this activity. Because Start Printed Page 25443Table 1 includes drugs identified as antineoplastic, NIOSH should clarify the rationale and intent of Table 1, since drugs used as antineoplastics, but which are not cytotoxic or genotoxic, as traditional antineoplastics are, have been included. Therefore, when drugs are grouped by their function (i.e., antineoplastic), as they were in earlier versions of Table 1, drugs that required different protective measures were grouped together (non-cytotoxic drugs with cytotoxic drugs).

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