THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION. SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MARKET, AND CAPABILITIES IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI FOR PLANNING PURPOSES IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. SOURCES SOUGHT/RFI DESCRIPTION This is NOT a solicitation announcement. This is a Sources Sought Notice / RFI only. The purpose of this Sources Sought Notice / RFI is to gain information about potential qualified sources and their size classification relative to NAICS 325412 (size standard of 1,300 Employees). Responses to this Sources Sought Notice / RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought Notice / RFI, further RFIs and/or a solicitation or other announcements may be published. The Department of Veterans Affairs (VA) is seeking a vendor able to provide the manufacturing and delivery of compounded chemotherapy drugs from an FDA 503A-compliant facility for the treatment of patients receiving services at the VA Long Beach Healthcare System located at 5901 East 7th Street, Long Beach, CA 90822-5201. No remanufactures or gray market items will be acceptable. Vendor shall be an Original Equipment Manufacturer (OEM), authorized dealer, authorized distributor or authorized reseller verified by an authorization letter or other documents from the OEM. Requirement: The contractor must be able to compound and provide the hazardous medications, including supportive medications, for the VA Long Beach Pharmacy; approximately thirty patients on any given day throughout the performance period. The medications required are included in, but not limited to, the list below. All medications must be delivered with no less than 12 hours remaining on the Beyond-Use-Date (BUD) and no sooner than 6 pm PST/PDT on the date of delivery to allow adequate time for the administration to clinic patients during their regularly scheduled appointments. The contractor must have a certified 503A pharmacy(s) with an active board of pharmacy license that are licensed to ship into/within the State of California. The contractor must complete and meet all requirements for national VA Pharmacy Benefits Management (PBM) Compounded Sterile Products Assessment guidelines. The contractor must be able to provide documentation of compliance with the standards outlined in the current version of USP 797. The contractor must provide any current or past survey or inspection results and responses from the Joint Commission, Board of Pharmacy, FDA, or any other governing body. The contractor must be able to provide stability data for all medications upon request. Medications shall not be delivered until ordered by the government. The contractor shall notify the government of any anticipated shortages, recalls, or discontinuation of the medications. The contractor must be able to ensure and provide documentation that medications are handled appropriately per the manufacturer s specifications prior to the receipt of the medication by VA Long Beach. Medications must meet the technical specifications stated in the FDA-approved package. Medication must be stored and used according to the directions on the labeling. If deviating from the FDA-approved package insert, the vendor must submit supporting evidence of practice and must be approved by the government before implementation. Deliverables: Generic Name Brand Name Abatacept Orencia 125mg 4/box Abatacept Orencia 250mg Abatacept Orencia Click-Jet 125mg 4/box Abobotulinumtoxin A Dysport 500u Adalimumab Humira 40mg/0.8ml Pen 2/box Ado-trastuzumab emtansine Kadcyla 100mg/15ml Ado-trastuzumab emtansine Kadcyla 160mg/20ml Aflibercept Eylea 2mg Alteplase Cathflo Activase 2mg Amifostine Amifostine 500mg via-l 3/bx Amikacin Amikacin Sulfate PF 500mg/2ml 10/box Amphotericin B Amphotericin B 50mg Arginine R-Gene HCL 300ml Aripiprazole Ability Maintena 400mg Syringe Arsenic Trisenox 10mg 10/box Arsenic Trisenox 12mg 10/box Asparaginase Erwinia Erwinaze 10,000iu/vi - Svl/box Atezoliumab Tecentriq 60mg/ml 20ml Atropine Atropine 0.4mg/ml 25/box Atropine Atropine 1mg syringe 10/box Atropine Atropine lmg/ml 25/box Avelumab Bavencio 20mg/ml 10ml Azacitidine Azacitidine 100mg Bacteriostatic Water Bacteriostatic Water 30ml 25/box BCG LIVE TICE BCG 50mg Belimumab Benlysta 120mg Belimumab Benlysta 400mg Bendamustine Belrapzo (Eagle brand) 100mg Bendamustine Bendeka 100mg Bendamustine Treanda 100mg PWD Bendamustine Treanda 25mg PWD Benralizumab Fasenra 30mg Syr Bevacizumab Avastin 100mg Bevacizumab Avastin 400mg Bevacizumab-AWWB Mvasi 100mg Bevacizumab-AWWB Mvasi 400mg Bevacizumab-BVZR Zirabev 100mg Bevacizumab-BVZR Zirabev 400mg Bezlotoxumab Zinplava 1000mg Bleomycin Bleomycin 15u Blinatumomab Blincyto 35mcg Bortezomib Velcade 3.5mg Brentuximab Vedotin Adcetris 50mg Cabazitaxel Jevtana 60mg Calcium Gluconate Calcium Gluc 100mg 10% 10ml 25/box Calcium Gluconate Calcium Gluconate 10% 50ml 25/box Carboplatin Carboplatin 150mg Carboplatin Carboplatin 450mg Carboplatin Carboplatin 50mg Carboplatin Carboplatin 600mg Carfilzomib Kyprolis 30mg Carfilzomib Kyprolis 60mg Carmustine BicNu 100mg Carmustine in Polifeprosan Gliadel Wafer Cefazolin Cefazolin 1gm 25/box Cefepime Cefepime 1gm 10/box Ceftazidime Ceftazidime 2gm 10/box Ceftazidime Tazicef 1gm 25/box Ceftriaxone Ceftriaxone 1 gm 10/box Certolizumab Cimzia 200mg Syr 2/box Cetuximab Erbitux 100mg Cidofovir Cidofovir Cisplatin Cisplatin 100mg Cisplatin Cisplatin 50mg Cladribine Cladribine 10mg Clindamycin Clindamycin 300mg/50ml ea. Clindamycin Clindamycin 600mg/4ml ea. Clofarabine Clolar 20mg Collagenase Clostridium Hist Xiaflex 0.9mg vial Cyanocobalamin Cyanocobalamin 1000mcg/1ml 25/box Cyclophosphamide Cyclophosphamide 1gm Cyclophosphamide Cyclophosphamide 1gm Cyclophosphamide Cyclophosphamide 25mg (100 tabs) Cyclophosphamide Cyclophosphamide 2gm Cyclophosphamide Cyclophosphamide 500mg Cyclophosphamide Cyclophosphamide 50mg (100 tabs) Cyclosporine Cyclosporine 250mg/5ml 10/box Cytarabine Cytarabine 100mg 5/box Cytarabine Cytarabine 2gm Cytarabine Liposomal Depocyt 50mg Dacarbazine Dacarbazine 200mg 10/box Dactinomycin Cosmegen 0.5mg Daratumumab Darzalex 100MG Daratumumab Darzalex 400MG Daunorubicin Daunorubicin 20mg/4mL 10/box Decitabine Dacogen 50mg Deferoxamine Deferoxamine 500mg 4/box Degarelix Firmagon 240mg (2 x120) Degarelix Firmagon 80mg Denosumab Prolia 60mg Denosumab Xgeva 120mg Dexamethasone Dexamethasone 10mg/mL 10mL 10/box Dexamethasone Dexamethasone 10mg/ml 1ml 25/box Dexamethasone Dexamethasone 4mg/ml 1ml 25/box Dexamethasone Ozurdex Implant 0.7mg Kit (DS item 1-2 days) Dexrazoxane Zinecard (Dexrazoxane) 500mg Diphenhydramine Diphenhydramine 50mg 25/box Docetaxel Docetaxel 160mg/8ml (20mg/ml) Docetaxel Docetaxel 20mg/2ml (10mg/mL) Docetaxel Docetaxel 80mg/8ml (10mg/mL) Doxorubicin Adriamycin 50mg Doxorubicin Doxorubicin 10mg 10/box Doxorubicin Doxorubicin 20mg Doxorubicin Doxorubicin 50mg Doxorubicin Doxorubicin 50mg Durvalumab Imfinzi 120mg Durvalumab Imfinzi 500mg Eculizumab Soliris 300mg Enfortumab Vedotin EJFV Padcev 30mg Ep9etin Epogen 10k unit 10/box Epinepherine Epinepherine 1:1000 25/box Epinepherine Epinepherine 30mg vial Epirubicin Epirubicin 200mg Epirubicin Epirubicin 50mg Epoetin Epogen 20k unit 10/box Epoetin Epogen 4k unit 10/box Epoetin Procrit 10k unit 6/box Epoetin Procrit 20k unit 4/box Epoetin Procrit 40k unit 4/box Epoetin Procrit 4k unit 6/box Epoetin Alfa EPBX Retacrit 10k unit 10/box Epoetin Alfa EPBX Retacrit 40k unit 4/box Eribulin Mesylate Halaven 1mg Ertapenem lnvanz 1gm 10/box Etanercept Enbrel Mini 50mg/0.98ml Cart Etoposide Etoposide 100mg Etoposide Etoposide 1gm Etoposide Etoposide 500mg Famotidine Famotidine 20mg 25/box FAM-Trastuzumab-Deruxtecn-nxkiFAM Enhertu 100mg pwd Ferric Carboxymaltose Injectafer 750mg Ferric Gluconate Ferric Gluconate 62.5mg 10/box Ferumoxytol Feraheme 510mg Filgrastim Neupogen 300mcg syringe 10/box Filgrastim Neupogen 480mcg syringe 10/box Filgrastim AAFI 480mcg/0.8ml Syr each Nivestym 480mcg/0.8ml Syr each Filgrastim-Sndz Zarxio 300mcg syringe ea. Filgrastim-Sndz Zarxio 480mcg syringe ea. Floxuradine Floxuradine 500mg Fludarabine Fludarabine 50mg Fluorouracil Fluorouracil 1gm 10/box Fluorouracil Fluorouracil 2.5gm Fluorouracil Fluorouracil 500mg 10/box Fluorouracil Fluorouracil 5gm Fosaprepitant Emend 150mg Foscarnet Sodium Foscavir Ggm 10/box Fulvestrant Faslodex 250mg 2/box Furosemide Furosemide 100mg vial 25/box Furosemide Furosemide 20mg 25/box Ganciclovir Ganciclovir 500mg (Cytovene) 25/box Gemcitabine Gemcitabine 1gm Gemcitabine Gemcitabine 1gm (100mg/ml 10ml) Gemcitabine Gemcitabine 200mg Gemcitabine Gemcitabine 200mg (100mg/ml 2ml) Gemcitabine Gemcitabine 2gm Gemtuzumab Ozogamicin Mylotarg 4.5mg Gentamicin Sulfate Gentamicin 80mg 25/box Golimumab Simponi Aria 12.5mg/ml 4ml Granisetron Granisetron Hydrochloride 1mg Granisetron Granisetron Hydrochloride 4mg Heparin Sodium Heparin Sodium 1000u/ml 1ml 25/box Hyaluronate Sodium Euflexxa 1% 20mg/2ml (20mg) syringe 3x2ml Hyaluronate Sodium Gel-One 30mg/3ml Syringe Hyaluronate Sodium Gelsyn-3, 8.4mg/ml 2ml syringe Hyaluronate Sodium Hyalgan 20mg/2ml syringe Hyaluronate Sodium Monovisc 22mg/ml 4ml Syringe Hyaluronate Sodium Orthovisc 30mg/2ml Syringe Hyaluronate Sodium Supartz 25mg/2.5ml Syringe Hyaluronate Sodium Synvisc 16mg/2ml 3x2ml Syringe Hyaluronate Sodium Synvisc-One 48mg/6ml Syringe Hyaluronate Sodium Visco-3 10mg/ml 3x 2.5ml Syringe Hydrocortisone Solu-Cortef 100mg Idarubicin Idarubicin 10mg Idarubicin Idarubicin 20mg Idarubicin Idarubicin 5mg Ifosfamide Ifosfamide 1gm Immune Globulin IVIG Octagam 10% 10gm Immune Globulin IVIG Octagam 10% 20gm Immune Globulin IVIG Octagam 10% 2gm Immune Globulin IVIG Octagam 10% 5gm Incobotulinumtoxin A Xeomin PR 200u PF Infliximab Remicade 100mg Infliximab-ABDA Renflexis 100mg Infliximab-DYYB lnflectra 100mg Interferon alfa 2-b lntron A l0mu Iohexal Omnipaque 300mg/50ml 10/box Iopamidol lsovue-300mg 61% 10x30ml Ipilimumab Yervoy 200mg Ipilimumab Yervoy 50mg Irinotecan Irinotecan 100mg Irinotecan Irinotecan 40mg Iron Dextran Infed 100mg 10/box Iron Sucrose Venofer 100mg 10/box Iron Sucrose Venofer 200mg 5/box IVIG ·Gamma gard 1gm vial IVIG Atgam S0mg/ml SxSml amp IVIG Carimune 12gm IVIG Carimune 6gm IVIG Gammagard 20gm vial IVIG Gammagard 5gm vial IVIG Gammagard 10gm vial IVIG Gammaked 10gm IVIG Gammaked 1gm IVIG Gammaked 2.5gm IVIG Gammaked 20gm IVIG Gammaked 5gm LC BEADS 100-300um 2ml LC BEADS 300-500um 2ml LC BEADS 70-150um 2ml Leucovorin Leucovorin 100mg Leucovorin Leucovorin 350mg Leuprolide Acetate Eligard 22.5mg Leuprolide Acetate Eligard 30mg Leuprolide Acetate Eligard 45mg Leuprolide Acetate Eligard 7.5mg Leuprolide Acetate Leuprolide 14mg 2.8ml 14 day kit Leuprolide Acetate Lupron Depot 11.25mg Leuprolide Acetate Lupron Depot 3.75mg Levoleucovorin Fusilev 50mg Lidocaine Lidocaine 4% 40mg/ml 25x5ml Liposomal Doxorubicin Liposomal Doxorubicin 20mg Liposomal Doxorubicin Liposomal Doxorubicin 50mg Liposomal Irinotecan Onivyde 4.3mg/ml 10ml Lorazepam Lorazepam 2mg/1mL 10/box Lurbinectedin Zepzelca 4mg Magnesium Sulfate Magnesium Sulfate 1gm/2mL 25/box Mannitol Mannitol 25% 50mL each 25/box Mechlorethamine Mechlorethamine 10mg 4/box Melphalan Alkeran 50mg Mepolizumab Nucala 100mg Mesna Mesna 1gm Methotrexate Methotrexate 50mg PF 10/box Methotrexate Methotrexate PF 1gm Methotrexate Methotrexate PF 250mg 10ml Methylene Blue Provayblue 0.5% Sx10ml Methylprednisolone Solu-Medrol (A-Methapred) 125mg 25/box Methylprednisolone Solu-Medrol (Methylprednisolone 40mg) x25 Metoclopramide Metoclopramide 10mg 25/box Mitomycin Mitomycin 20mg Mitomycin Mitomycin 40mg Mitomycin Mitomycin 5mg Mitoxantrone Novantrone 20mg Mitoxantrone Novantrone 25mg Mycophenolate Mofetil Cellcept 500mg 4x20ml Naltrexone Vivitrol 380mg Natalizumab Tysabri 300mg Nelarabine Arranon SF 250mg 6/box Nivolumab Opdivo 100mg/10ml SDPF Nivolumab Opdivo 240mg/10ml SDPF Nivolumab Opdivo 40mg/4ml SDPF Normal Saline 0.9% NACL 50ml 25/box Obinutuzumab Gazyva 1000mg/40ml SDV PF Ocrelizumab Ocrevus 300mg Octreotide Octreotide 100mcg 10/box Octreotide Sandostatin LAR 10mg Octreotide Sandostatin LAR 20mg Octreotide Sandostatin LAR 30mg Ofatumumab Arzerra 20mg/ml 3x5ml ' Ofatumumab Arzerra 20mg/ml lxS0ml Omalizumab Xolair 150mg Syringe Omalizumab Xolair 75mg Syringe Onabotulinumtoxina Botox 100iu (drop ship - dr info req) Oncozene Beads 100mcm Ondansetron Ondansetron 40mg Ondansetron Ondansetron 4mg 25/box Oxaliplatin Oxaliplatin 100mg Oxaliplatin Oxaliplatin 50mg Paclitaxel Paclitaxel 100mg Paclitaxel Paclitaxel 300mg Paclitaxel Paclitaxel 30mg Palifermin Kepivance 6.25mg/ml 3/box Palonosetron Palonosetron 0.25mg Pamidronate Pamidronate 30mg Pamidronate Pamidronate 90mg Panitumumab Vectibix 100 Panitumumab Vectibix 400 PB Paclitaxel Abraxane 100mg Pegasparaginase Oncaspar 3,750 units Pegfilgrastim Fulphila 6mg/0.6ml syringe Pegfilgrastim Neulasta 6mg syringe Pegfilgrastim Neulasta Onpro Delivery Kit 6mg Pegfilgrastim Udenyca 6mg/0.6ml syringe Pembrolizumab Keytruda 100mg Pembrolizumab Keytruda 100mg x2 Pemetrexed Alimta 100mg Pemetrexed Alimta 500mg Pentamidine Isethionate Pentam 300mg 10/box Pentamidine lsethionate Nebupent 300mg Pentostatin Nipent 10mg Pertuzumab Perjeta 420mg Polatuzumab Vedotin-PIIQ Polivy 30mg Potassium Potassium Chloride 20meq 25/box Pralatrexate Folotyn 20mg Pralatrexate Folotyn 40mg Prochlorperazine Prochlorperazine Edisylate 10mg 10/box Promethazine Promethazine 25mg 25/box Ramucirumab Cyramza 100mg Ramucirumab Cyramza 500mg Ranibizumab Lucentis .3mg/.05ml vial Ranibizumab Lucentis .5mg/.0SmL vial Ranitidine Ranitidine 50mg/2ml 10/box Rasburicase Elitek 1.5mg 3/box Rasburicase Elitek 7.5mg vial Rimabotulinumtoxinb Myobloc 5000u/ml 1ml Risankizumab-RZAA Skyrizi 75mg/0.83ml Rituximab Rituxan 100mg Rituximab Rituxan 500mg Rituximab-ABBS Truxima 100mg Rituximab-ABBS Truxima 500mg Rituximab-PVVR Ruxience 100mg Rituximab-PVVR Ruxience 500mg Romidepsin lstodax 10mg Romiplostim Nplate 250mcg Romiplostim Nplate 500mcg Sodium Bicarbonate Sodium Bicarbonate 8.4% 50ml syr 10/box Sodium Bicarbonate Sodium Bicarbonate 8.4% 50meq vial 25/box Tacrolimus Prograf 5mg/ml 1ml PF Amp 10/box Tbo-Filgrastim Granix 300mcg Syringe x1 Tbo-Filgrastim Granix 480 mcg Syringe x1 Temsirolimus Torisel 25mg Testosterone Depo-Testosterone 200mg/10ml Tetracaine Tetracaine .5% OPHT Sol 12/box Thiotepa Thiotepa 15mg Thyrotropin Thyrogen 1.1mg x2 Tocilizumab Actemra 200mg Tocilizumab Actemra 400mg Tocilizumab Actemra 80mg Topotecan Topotecan 4mg Trabectedin Yondelis 1mg Trastuzumab Herceptin 150mg Trastuzumab-ANNS Kanjinti 150mg Trastuzumab-ANNS· Kanjinti 420mg Trastuzumab-QYYP Trazimera 420mg Triamcinalone PF Triesence 40mg/1ml PF Triptorelin Trelstar 3.75mg Ustekinumab Sterlara 130mg Smg/ml 26ml Valrubicin Valstar 40mg/ml 5ml SDV 4/box Vancomycin Vancomycin 1gm 10/box Vedolizumab Entyvio 300mg 20ml SDV Vinblastine Vinblastine 10mg Vincristine Vincristine 1mg Vincristine Vincristine 2mg Vinorelbine Vinorelbine 10mg If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of SALIENT CHARACTERISTICS/SOW requirements. For instances where your company cannot meet the SALIENT CHARACTERISTICS/SOW requirement(s), please explain. For instances where your company can meet the SALIENT CHARACTERISTICS/SOW requirement(s), please show how your company meets/exceeds each requirement. (2) Please review the list of SALIENT CHARACTERISTICS/SOW requirements and provide any additional feedback or suggestions. If none, please reply as N/A. (3) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc. (4) Is your company considered small under the NAICS code identified in this RFI? (5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of SALIENT CHARACTERISTICS/SOW? (6) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available). (7) If you re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified. (8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6? (9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items? (10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? (11) Please indicate whether your product conforms to the requirements of the Buy American Act? (12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate. (13) What is estimated life span of your solution? What support/services does that entail? (14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained. (15) Does your organization offer a leasing solution? Please elaborate. (16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s). (17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract. (18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (19) Please provide your SAM.gov Unique Entity ID/Cage Code number. Responses to this notice shall be submitted via email to Hestia.Sim@va.gov. Telephone responses will not be accepted. Responses must be received no later than Friday, August 2, 2024 by 10:00 PM Pacific Local Time. All responses to this Sources Sought/RFI will be used for planning purposes only. Responses to this Sources Sought Notice / RFI are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation. If further RFIs and/or a solicitation or other announcement is issued as a result of the information provided from this RFI, all interested parties must respond to the specific posting separately IAW the specifications of that announcement.
