USP <795> Consensus Statement from the Nonsterile Compounding Consensus Group
A review of the recently posted new draft of USP <795> has just been released by the Nonsterile Compounding Consensus Group (NCCG). This group, consisting of a diverse array of experts with many decades of experience, has been endorsed by the Accreditation Commission for Health Care/Pharmacy Compounding Accreditation Board (ACHC/PCAB) and the International Academy of Compounding Pharmacists (IACP).
This "Comments on the Draft 795" consists of: 1) concise summaries of most sections, especially if content has changed, 2) statements of approval in the event of what are seen as useful changes, and 3) critiques of controversial content, including suggested changes.
The NCCG Comments on the Draft 795 document can be accessed at:
http://CompoundingToday.com
The USP 795 draft can be accessed at:
http://www.usp.org/compounding/general-chapter-795
- Every nonsterile compounder is encouraged to obtain a copy of these comments as well as the proposed 795 draft, and carefully examine both.
- An Open Microphone Session sponsored by the USP is scheduled for April 20. You can register for this event on the same website as shown above.
- This website also provides for the submission of comments concerning the draft to USP.
Editor's Note: Beginning next week, in this newsletter, we will also look in detail at the various sections (2 per week) in the proposed USP <795> revision.
CDC NIOSH New and Revised List Proposals
ACTION: Notice of draft document available for public comment.
SUMMARY: NIOSH has announced the availability for public comment on the drugs proposed for placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018 (List).
DATES: Comments must be received 60 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER; It was scheduled to be published in the Federal Register on 02/14/2018 and available online at https://federalregister.gov/d/2018-02957, and on FDsys.gov
Go to the following URL to obtain a copy and complete instructions to comment.
https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-02957.pdf
I. Public Participation
Interested parties are invited to participate in this action by submitting written views, opinions, recommendations, and/or data. Comments are invited on any topic related to the drugs identified in this notice, including those evaluated for placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018.
After consideration of the peer reviews, NIOSH sorts all screened and evaluated drugs into one of five categories:
- Category 1: Special handling information
- Category 2: Insufficient toxicity information available to meet the NIOSH definition of a hazardous drug
- Category 3: Available information shows no toxic effect or shows a toxic effect that does not meet the NIOSH definition of a hazardous drug
- Category 4: Available toxicity information demonstrates or supports a determination that the drug does not meet the NIOSH definition of a hazardous drug
- Category 5: Available toxicity information demonstrates or supports a determination that the drug meets the NIOSH definition of a hazardous drug
Table 1. Insufficient Toxicity Information Available to Meet NIOSH Definition of Hazardous Drug (Category 2)
- 20 drugs are listed in this table
Table 2. Available Information Shows a Toxic Effect that Does Not Meet the NIOSH Definition of Hazardous Drug (Category 3)
- 211 drugs are listed in this table
Table 3. Available Toxicity Information Does Not Demonstrate or Support a Determination that the Drug Meets the NIOSH Definition of a Hazardous Drug (Category 4)
- 23 drugs are listed in this table
Table 4. Drugs Proposed for Placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (Category 1 -- Special Handling Information & Category 5 -- Drug Meets the NIOSH Definition of Hazardous Drug) Generic Drug Name
- 22 drugs are listed in this table
Drugs Removed from the NIOSH List of Hazardous Drugs
Telavancin
Final List of Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs
After consideration of all public comments received in the docket for this action, NIOSH will develop a final list of drugs to be placed on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018. The 2018 Update will be published on the NIOSH website and announced in a Federal Register notice.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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