NIOSH

Product Shipping Update

General Chapter <800> Hazardous Drugs

The U.S. Pharmacopeia Convention (USP) issued new guidance and quality standards (General Chapter <800> Hazardous Drugs-Handling in Healthcare Settings) which will go into effect on December 1, 2019. This guidance applies to hazardous or potentially hazardous drugs defined by the National Institute for Occupational Safety and Health (NIOSH) handled in healthcare settings.
 
At Besse Medical, we are dedicated to the highest safety and security standards to ensure the integrity of the pharmaceutical supply chain. All pharmaceuticals are handled, stored, and shipped in compliance with the specifications mandated by the drug manufacturer in product packaging and/or the Food and Drug Administration (FDA). We are required to comply with all applicable federal, state and local laws and regulations, as such, hazardous materials are handled, stored and shipped according to EPA, OSHA and DOT regulations.
 
Although this guidance does not apply to pharmaceutical distributors, our customers have asked for our help, so starting on June 11, 2018, Besse Medical is placing products considered to be Table 1 according to the NIOSH USP 800 standards into a bag marked “ANTINEOPLASTIC DRUG” (shown below):
 

Table 1 products will ship in separate coolers or boxes from all other products. We will place a N1 (for NIOSH Table 1) on the shipping labels as shown below:


You will receive NIOSH Table 2 and NIOSH Table 3 items with non-hazardous items. If applicable, the highest hazardous class will be identified on the shipping label. For example, if a package contains both a Table 2 item and a Table 3 item, “N2” will be identified on the shipping label.


For your reference, NIOSH Table 1, 2 and 3 items are defined below:
 

Below is a list of pharmaceuticals distributed by Besse Medical that fall into the tables above:
 
Table 1: Abraxane, Bleomycin, Camptosar, Carboplatin, Cisplatin, Cyclophosphamide, Daunorubicin, Docetaxel, Doxorubicin, Eligard, Firmagon, Fluorouracil, Gemcitabine, Megestrol, Methotrexate, Mitomycin, Paclitaxel, Tarceva, Taxotere, Toposar, Valstar, Vinblastine, Vincristine, Xeloda and Zoladex.
 
Table 2: Depo-Estradiol, Depo-Provera, Dilantin/Phenytoin, Dilalproex, Estradiol, Medroxyprogesterone, Oral Contraceptives, Premarin, Progesterone, Restasis, Risperidone, Spironolactone, and Tegretol/Carbamazepine.
 
Table 3: Androgel, Aveed, Clonazepam, Coumadin/Warfarin, Depacon, Depo-Testosterone (Testosterone Cypionate), Finasteride, Fluconazole, Geodon, HCG, Jantoven, Misoprostol, Ovridel, Pitocin/Oxytocin, Paroxetine, Prepidil, Propecia, Proscar, Renova, Retin-A/Tretinoin, Testim, Testopel, Testosterone Enanthate, Topiramate, Valproate, Valproic Acid, VFend, and Vibativ.
 

Frequently Asked Questions 

For additional information regarding NIOSH USP <800> Requirements, please refer to our Frequently Asked Questions or contact Customer CARE at 1.800.543.2111.
 
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