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Verified Clinical Benefit | Cancer Accelerated Approvals

Darzalex Faspro (daratumumab and hyaluronidase-fihj)Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients1/15/202111/19/2025Imdelltra (tarlatamab-dlle)Adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy5/16/202411/19/2025Epkinly (epcoritamab-bysp)Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy6/24/202411/18/2025Yervoy (ipilimumab)In combination with nivolumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib3/10/20204/11/2025Opdivo (nivolumab)In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib3/10/20204/11/2025Vitrakvi (larotrectinib)Treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative treatments or that have progressed following treatment11/26/20184/09/2025Opdivo (nivolumab)For the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan7/31/20174/08/2025Opdivo (nivolumab)In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan7/10/20184/08/2025Yervoy (ipilimumab)In combination with nivolumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan7/10/20184/08/2025Keytruda (pembrolizumab)In combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma 1 5/5/20213/19/2025Calquence (acalabrutinib)Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy10/31/20171/16/2025Retevmo (selpercatinib)Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy *5/8/20209/27/2024Retevmo (selpercatinib)Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) *5/8/20206/12/2024Tivdak (tisotumab vedotin-tftv)Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy9/20/20214/29/2024Elahere (mirvetuximab soravtansine-gynx)Adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test11/14/20223/22/2024Rybrevant (amivantamab-vmjw)Treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum based chemotherapy5/21/20213/1/2024Tepmetko (tepotinib)Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.2/3/20212/15/2024Keytruda (pembrolizumab)Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib11/9/20181/25/2024Balversa (erdafitinib) Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has: susceptible FGFR3 or FGFR2 genetic alterations, and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. 4/12/20191/19/2024Padcev (enfortumab vedotin-efjv)In combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy4/3/202312/15/2023Keytruda (pembrolizumab)In combination with enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy4/3/202312/15/2023Keytruda (pembrolizumab) Treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)12/19/201810/12/2023Bavencio (avelumab)Treatment of adults and pediatrics patients 12 years and older with metastatic merkel cell carcinoma (MCC)3/23/20179/6/2023Gavreto (pralsetinib)Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test9/4/20208/9/2023Blincyto (blinatumomab)Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children 3/29/20186/20/2023Libtayo (cemiplimab-rwlc)Patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate2/9/20214/28/2023Polivy (polatuzumab vedotin- piiq)In combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.6/10/20194/19/2023Keytruda (pembrolizumab)Treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or metastatic MSI-H or dMMR colorectal cancer that have progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan5/23/20173/28/2023Jemperli (dostarlimab-gxly) Adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen.4/22/20212/9/2023Scemblix (asciminib)Adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)10/29/202110/12/2022Retevmo (selpercatinib)Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC) 5/8/202009/21/2022Tabrecta (capmatinib) Adult patients with mNSCLC whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test5/6/20208/10/2022Clolar (clofarabine)Treatment of pediatric patients 1 to 21 yrs old with relapsed or refractory acute lymphocytic leukemia (ALL) after at least 2 prior regimens12/28/20047/18/2022Enhertu (Fam-trastuzumab deruxtecan-nxki)Adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting 12/20/20195/4/2022Keytruda (pembrolizumab)In combination with chemotherapy for locally recurrent unresectable or metastatic TNBC expressing PD L1 [CPS =10] as determined by an FDA-approved test11/13/20207/26/2021Trodelvy (sacituzumab govitecan-hziy)Adults with metastatic TNBC following at least 2 prior therapies for metastatic disease4/22/20204/7/2021Padcev (enfortumab vedotin-ejfv)Adults with locally advanced or metastatic urothelial cancer who received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant, locally advanced, or metastatic setting12/18/20197/9/2021Keytruda (pembrolizumab)In combination with lenvatinib for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiation9/17/20197/21/2021Lenvima (lenvatinib)In combination with pembrolizumab for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiation9/17/20197/21/2021Xpovio (selinexor)In combination with dexamethasone for adults with relapsed/refractory multiple myeloma after at least 4 prior therapies and refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody7/3/201912/18/2020Venclexta (venetoclax)In combination with azacitidine or decitabine or low-dose cytarabine for newly-diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy11/21/201810/16/2020Lorbrena (lorlatinib)ALK-positive metastatic NSCLC that has progressed on: • Crizotinib and at least one other ALK inhibitor for metastatic disease; or • Alectinib as the first ALK inhibitor therapy for metastatic disease; or • Ceritinib as the first ALK inhibitor therapy for metastatic disease11/2/20183/3/2021Keytruda (pembrolizumab)Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after 2 or more prior lines of therapy6/13/201810/14/2020Keytruda (pembrolizumab)Treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >/=1) as determined by an FDA approved test6/12/201810/13/2021Alimta (pemetrexed disodium)In combination with pembrolizumab and carboplatin for first-line treatment of metastatic non-squamous NSCLC6/4/20181/30/2019Bosulif (bosutinib)Adults with newly diagnosed chronic phase Philadelphia chromosome positive CML12/19/20175/14/2021Keytruda (pembrolizumab)Locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy 5/18/20178/31/2021Keytruda (pembrolizumab)In combination with pemetrexed and carboplatin for first-line treatment of metastatic non-squamous NSCLC5/10/20178/20/2018Bavencio (avelumab)Locally advanced or metastatic urothelial carcinoma following diease progression on platinum-containing chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy5/9/20176/30/2020Alunbrig (brigatinib)Patients with ALK-positive metastatic NSCLC that have progressed or are intolerant to crizotinib4/28/20175/22/2020Keytruda (pembrolizumab)Adult and pediatric patients with refractory classical Hodgkin Lymphoma or who have relapsed after 3 or more prior lines of therapy3/14/201710/14/2020Opdivo (nivolumab)Locally advanced or metastatic urothelial carcinoma that: • progressed during or following platinum-containing chemotherapy • progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy2/2/20178/19/2021Rubraca (rucaparib)Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies 12/19/20164/6/2018Keytruda (pembrolizumab)Recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy8/5/20166/10/2019Venclexta (venetoclax)Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapy4/11/20166/8/2018Opdivo (nivolumab)1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitor1/23/20163/7/2019Alecensa (alectinib)ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib12/11/201511/6/2017Darzalex (daratumumab)Multiple myeloma after at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or double refractory to a proteasome inhibitor and an immunomodulatory agent11/16/201511/21/2016Tagrisso (osimertinib)Metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, that progressed on or after EGFR TKI therapy11/13/20153/30/2017Keytruda (pembrolizumab)Metastatic PD-L1 positive NSCLC, as determined by an FDA-approved test, with progression on or after platinum-containing chemotherapy10/2/201510/24/2016Opdivo (nivolumab)In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma9/30/20153/7/2019Ibrance (palbociclib)In combination with letrozole for postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease2/3/20153/31/2017Opdivo (nivolumab)Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor12/22/20143/7/2019Lynparza (olaparib)Deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer after treatment with 3 or more lines of chemotherapy 12/19/20148/17/2017Blincyto (blinatumomab)Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia12/3/20147/11/2017Keytruda (pembrolizumab)Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor9/4/201412/18/2015Zykadia (ceritinib)ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib4/29/20145/26/2017Imbruvica (ibrutinib)Chronic lymphocytic leukemia after at least one prior therapy2/12/20147/28/2014Tafinlar (dabrafenib)In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test1/9/201411/20/2015Mekinist (trametinib)In combination with dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test1/8/201411/20/2015Perjeta (pertuzumab)In combination with trastuzumab and docetaxel for neoadjuvant treatment of HER2-positive locally advanced inflammatory or early-stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early early breast cancer9/30/201312/20/2017Pomalyst (pomalidomide)Multiple myeloma after at least 2 prior therapies including lenalidomide and bortezomib and disease progression on or within 60 days of completion of the last therapy2/8/20134/23/2015Iclusig (ponatinib)Adults with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia resistant or intolerant to TKI therapy or or Philadelphia chromosome positive acute lymphoblastic leukemia resistant or intolerant to prior TKI therapy12/14/201211/28/2016Synribo (omacetaxine mepesuccinate)Adults with chronic or accelerated phase chronic myeloid leukemia with resistance or intolerance to 2 or more TKIs10/26/20122/10/2014Kyprolis (carfilzomib)Multiple myeloma after at least 2 prior therapies including bortezomib and an immunomodulatory agent and disease progression on or within 60 days of completion of the last therapy7/20/20121/21/2016Afinitor (everolimus)Adults with renal angiomyolipma and tuberous sclerosis complex not requiring immediate surgery4/26/20122/18/2016Xalkori (crizotinib)Locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved test8/26/201111/20/2013Adcetris (brentuximab vedotin)Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT), or after failure of at least 2 multi-agent chemotherapy regimens in patients who are not ASCT candidates8/19/20118/17/2015Adcetris (brentuximab vedotin)Systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemotherapy regimen8/19/20113/20/2018Afinitor (everolimus)Patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection10/29/20101/29/2016Sprycel (dasatinib)Newly diagnosed adults with Philadelphia chromosome-positive CML in chronic phase10/28/20108/12/2015Tasigna (nilotinib)Newly diagnosed adults with with Philadelphia chromosome-positive CML in chronic phase6/17/20101/27/2015Tykerb (lapatinib)In combination with letrozole for post-menopausal women with HR-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated1/29/201012/6/2018Arzerra (ofatumumab)Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab10/26/20094/17/2014Avastin (bevacizumab)Progressive glioblastoma following prior therapy5/5/200912/5/2017Gleevec (imatinib mesylate)Adjuvant treatment of adults following complete gross resection of KIT (CD117) positive gastrointestinal stromal tumors (GIST)12/19/20081/31/2012Alimta (pemetrexed disodium)Non-squamous NSCLC: 1) as initial treatment with cisplatin; 2) as a single agent after prior chemotherapy9/26/20087/2/2009Tasigna (nilotinib)Chronic phase and accelerated phase Philadelphia chromosome positive CML in adults resistant or intolerant to prior therapy that included Gleevec (imatinib)10/29/20071/14/2011Gleevec (imatinib mesylate)Newly diagnosed Philadelphia positive CML in pediatric patients9/27/20064/1/2011Vectibix (panitumumab)EGFR-expressing metastatic colorectal carcinoma with progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens9/27/20065/23/2014Sprycel (dasatinib)Chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib6/28/20065/21/2009Thalomid (thalidomide)Newly diagnosed multiple myeloma5/25/20066/19/2014Sutent (sunitinib maleate)Advanced renal cell carcinoma1/26/20062/2/2007Femara (letrozole)Postmenopausal women with HR positive early breast cancer12/28/20054/30/2010Arranon (nelarabine)Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia following at least 2 chemotherapy regimens10/28/20057/31/2019Femara (letrozole)Extended adjuvant treatment of early breast cancer in postmenopausal women who received 5 years of adjuvant tamoxifen10/29/20044/30/2010Alimta (pemetrexed disodium)As a single agent for locally advanced or metastatic NSCLC after prior chemotherapy8/19/20047/2/2009Erbitux (cetuximab)In combination with irinotecan for EGFR-expressing metastatic colorectal carcinoma refractory to irinotecan-based chemotherapy2/12/20047/6/2012Erbitux (cetuximab)As a single agent for EGFR-expressing metastatic colorectal carcinoma intolerant to irinotecan-based chemotherapy2/12/200410/2/2007Gleevec (imatinib mesylate)Pediatric patients with recurrent PH+ chronic phase CML after stem cell transplant or who are resistant to interferon alpha therapy5/20/20039/27/2006Velcade (bortezomib)Multiple myeloma patients who received at least two prior therapies and demontrated disease progression on the last therapy5/13/20033/25/2005Gleevec (imatinib mesylate)Newly diagnosed adults with Philadelphia chromosome positive CML12/20/20025/27/2009Arimidex (anastrozole)Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer9/5/20029/16/2005Eloxatin (oxaliplatin)In combination with infusional 5-FU/LV for metastatic color or rectal carcinoma that progressed during or within 6 months of completion of first-line therapy with bolus 5 -FU/LV and irinotectan8/9/20021/9/2004Gleevec (imatinib mesylate)KIT (CD117) positive unresectable and/or metastatic GIST2/1/20029/26/2008Campath (alemtuzumab)B-cell CLL treated with alkylating agents and failed fludarabine therapy5/7/20019/19/2007Temodar (temozolomide)Adults with refractory anaplastic astrocytoma8/11/19993/15/2005Doxil (doxorubicin hydrochloride)Metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapy6/28/19991/28/2005Depocyt (cytarabine(liposomal))Intrathecal treatment of lymphomatous meningitis4/1/19994/19/2007Xeloda (capecitabine)Metastatic breast cancer resistant to paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and further anthracycline therapy is contraindicated4/30/19989/7/2001Camptosar (irinotecan hcl trihydrote)Metastatic colon or rectal carcinoma that progressed following 5-FU therapy6/14/199610/22/1998Taxotere (docetaxel)Locally advanced or metastatic breast carcinoma that progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy5/14/19966/22/1998Doxil (doxorubicin hydrochloride)Kaposi's sarcoma in AIDS patients with disease progression on prior combination chemotherapy or who are intolerant to such therapy11/17/19956/10/2008

Registered Outsourcing Facilities

Facilities Registered as Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Updated as of 1/13/2026 Information Concerning Outsourcing Facility Registration Outsourcing Facility Product Reporting Information This table lists the outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table. FacilityContactInitial Registration Date 1Most Recent Registration Date 1Last Inspection 2Form 483 Issued? 3Recall Conducted? 9Action Based on Last Inspection 4,5Intends to Compound Sterile Drugs From Bulk Substances 6503B Outsourcing Facility One, LLC, West Palm Beach, FLKenneth Metzler 1-754-265-42802/18/20252/18/2025Not yet inspectedN/AN/AN/AYesAH Nutraceutical Compounding, Inc., McQueeny, TXMichael Chase 1-312-401-74557/8/20241/3/2026Not yet inspectedN/AN/AN/AYesAjenat Pharmaceuticals, LLC, Largo, FLSupriya Taneja 1-727-506-12613/26/202511/26/2025Not yet inspectedN/AN/AN/AYesAspire Compounding Pharmacy, Sugar Land, TXAkwasi Amankwaah 1-281-501-05113/21/20253/21/2025Not yet inspectedN/AN/AN/AYesAnazaoHealth Corporation, Las Vegas, NVVic Williams 800-995-43639/23/201412/30/20258/8/2025YesNoOpen7YesAnnovex Pharma, Inc., Lorton, VAAdedayo Akinbi 1-571-642-5104 10/14/202111/22/20249/6/2024Yes NoWarning Letter Issued 3/5/2025YesApertus Compounding, LLC, Maryland Heights, MOSandra Oh 1-314-607-043211/26/202511/26/2025N/AN/AN/AN/AYesApocus, Inc., San Antonio, TXSuryanarayana Raju Sagi 1-214-797-717210/17/20231/1/2026Not yet inspectedN/AN/AN/AYesApollo Care, Columbia, MOJarred Dudding 573-441-89009/14/201712/24/20253/28/2025YesNoOpen7YesApothecary Pharma, LLC, Cary, NCPriyanka Rana 1-919-760-54789/7/20241/6/20265/15/2025YesNo Warning Letter Issued 12/1/2025YesArc Compounding Pharmacy LLC, Waco, TXClifton King 512-665-69116/22/20242/3/2025Not yet inspectedN/AN/AN/AYesAssure Infusions, Inc., Bartow, FLGloria Imbimbo 1-386-451-267311/22/202412/5/2025Not yet inspectedN/AN/AN/ANoAtilar Pharma Corporation, Houston, TXBenito Aguilar 1-713-992-38842/20/202512/24/2025Not yet inspectedN/AN/AN/AYesAveva Drug Delivery Systems, Inc, Tamarac, FLMadhuri Gupta 1-954-218-157011/4/202411/25/2025Not yet inspectedN/AN/AN/AYesBayCare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FLKyle Brauer 813-901-63766/4/201910/25/20246/2/2023YesNoFMD-145 Letter Issued 9/18/2023NoBennett Pharmaceuticals of America LLC, Hudson, WIJames Mulvahill 952-381-90274/19/20221/23/2025Not yet inspectedN/AN/AN/AYesBPI Labs LLC, Largo, FLChandra Kasireddy 727-471-08503/4/201912/3/20252/21/2025YesNoFMD-145 Issued 7/28/2025YesBravado Pharmaceuticals, LLC, Lutz, FLBrian McMillan 1-813-991-41002/28/20251/10/2026Not yet InspectedN/AN/AN/AYesBrookfield Medical/Surgical Supply, Inc., Brookfield, CTJames Cangelosi 203-775-08621/12/201512/30/20255/10/2024YesNoFMD-145 Letter Issued 2/13/2025YesBSO LLC, Golden, COMichelle Violi 608-221-7800 Ext 11131/24/202411/25/20256/27/2025483N/AOpenYesBSO LLC, Lakewood, COMichelle Violi 608-221-7800 Ext 111311/24/201511/26/20257/16/2025483NoOpen7YesCentral Admixture Pharmacy Services, Inc., Allentown, PAEric Bauer 1-551-204-41782/28/201411/21/20259/5/2025YesNoOpen7YesCentral Admixture Pharmacy Services, Phoenix, AZEric Bauer 1-551-204-41783/29/201811/21/20259/5/2025YesNoOpen7YesDelta Pharma, Inc., Ripley, MSStuart Simpson 662-512-51918/6/201412/31/202511/21/2025YesNoOpen7YesDenver Solutions, LLC, dba Leiters Health, Englewood, COBarbara Knightly 720-697-5140 Ext 40043/24/201711/28/202512/11/2025YesNoOpen7YesDenver Solutions, LLC, dba Leiters Health, Buena, NJBarbara Knightly 720-697-5140 Ext 40047/1/202211/26/2025Not yet inspectedN/AN/AN/AYesEagle Pharma, Birmingham, ALHaleigh Cawood 205-682-79996/16/201512/16/20252/27/2025YesNoOpen7YesEcho Health LLC dba Nova Specialty Pharmacy, Mansfield, TXObiechina Ezekwesili +1-682-267-85865/20/20242/18/2025Not yet inspectedN/AN/AN/AYesEmpower Clinic Services New Jersey, East Windsor, NJShaun Noorian 877-562-85776/10/202411/24/2025Not yet inspectedN/AN/AN/AYesEmpower Pharma, Houston, TXShaun Noorian 877-562-85777/16/201611/24/202511/14/2025YesNoOpen7YesExcite Pharma Services, LLC, Tonganoxie, KSKeith Koehler 1-816-572-01516/1/202112/24/2025Not yet inspectedN/AN/AN/AYesF.H. Investments, Inc., Birmingham, ALChristopher S. Musser 1-205-995-05055/13/202512/2/202512/19/2025YesNoOpenYesFagron Compounding Services dba Fagron Sterile Services, Wichita, KSDeborah McHugh 316-773-040510/2/201511/21/20258/8/2025483NoOpen7YesFarmakeio Outsourcing LLC, Southlake, TXCody Boatman 817-203-821612/12/201812/12/20259/5/2025YesNoOpen7YesFresenius Kabi Compounding LLC dba Fagron Sterile Services, Canton, MADeborah McHugh 316-773-04054/21/201711/22/202511/5/2025YesNoOpen7NoGalaxy Pharmaceuticals, LLC, Albany, NYDalbir Bains 1-646-957-77621/26/202411/26/2025Not yet inspectedN/AN/AN/AYesGenoGenix LLC, Boca Raton, FLHorace Smith 1-561-264-73032/4/20252/4/20257/18/2025YesN/AOpenYesGFC Pharma, LLC, Westminster, MDRanjeesh Gopinathan 215-264-999512/16/202412/30/2025Not yet inspectedN/AN/AN/AYesHikma Pharmaceuticals USA Inc., Cherry Hill, NJJ. Barton Kalis 856-489-22479/15/202112/29/20256/12/2024YesNoFMD-145 Issued 12/18/2024YesHikma Injectables USA Inc., Dayton, NJJ. Barton Kalis 856-489-22479/15/202112/29/20258/8/2025YesNoOpen7NoHyalo Technologies Limited Liability Company, Somerset, NJShalabh Jain 1-908-399-36005/1/202512/3/2025Not yet inspectedN/AN/AN/AYesHybrid Pharma, LLC, Deerfield Beach, CAPonswamy Rajalingam 954-708-27711/14/201512/16/202511/9/2023YesNoOpen7YesImprimis NJOF, LLC, Ledgewood, NJFred Weiss 973-328-8756 Ext=541111/12/201611/26/20254/3/2024YesNoRegulatory Meeting Held 10/21/2025YesIntegraDose Compounding Services, LLC, Minneapolis, MNCraig Else 612-672-52165/8/201812/13/20243/1/2024YesNoRegulatory Meeting Held 9/5/2024NoLeesar Inc., Fort Myers, FLMaria Gautier 239-939-89254/30/201411/26/20255/9/2025YesNoUntitled Letter Issued 11/21/2025NoMark Cuban Cost Plus Manufacturing and Compounding, LLC, Dallas, TXAlexander Oshmyansky 303-907-800311/2/202212/14/20249/6/2024YesNoFMD-145 Issued 6/5/2025YesMcGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions, Santa Ana, CAJacqueline McKay 714-918-7277 Ext 3141/11/202312/2/2025Not yet inspectedN/AN/AN/AYesMedi-Fare Drug, Blacksburg, SCAnne-Marie Davis 864-839-650012/17/201312/31/20256/6/2025YesNoOpen7YesMedisourceRx, Los Alamitos, CAVenus Firouzehee 714-455-13002/14/20171/2/20266/10/2025YesNoWarning Letter Issued 12/12/2025YesMolecular PharmaGroup, New Providence, NJAmanda Lanze 908-588-34405/8/201812/30/20258/11/2025YesNoOpen7YesNephron Sterile Compounding Center, LLC (NSCC), West Columbia, SCLou Wood Kennedy 803-569-31107/15/201412/15/20258/22/2025483NoOpen7YesNubratori, Inc., Torrance, CAGulshakar Khwaja 310-218-41532/24/201712/3/202512/11/2025YesNoOpen7YesOlympia Pharmaceuticals, Orlando, FLMark Mikhael 1-407-673-2222 3/10/201411/20/20258/8/2025483NoOpen7YesOrion Specialty Labs, LLCKimberly Mattera 1-917-414-24699/19/20259/19/2025Not yet inspectedN/AN/AN/AYesOSRX, Inc., Missoula, MTAmy Frost 406-541-612110/28/202312/29/202511/14/2025YesNoOpen7YesOurPharma LLC, Fayetteville, ARShelby Bush 479-313-8200 Ext 82273/15/201911/26/20259/27/2024YesNoOpen7YesPark Avenue Compounding, St. Louis, MOSteven Garhartt 603-953-667512/23/202311/19/20259/23/2025YesNoOpenNoPGRrx LLC, Exton, PA Amit Gupta 1-484-883-759712/10/202412/30/2025Not yet inspectedN/AN/AN/AYesPine Pharmaceuticals, LLC, Tonawanda, NYAlfonse Muto 716-248-10253/9/201811/19/202511/14/2025YesNoOpen7YesPQ Pharmacy LLC, Brooksville, FLAngela Kassay 352-477-897710/29/202012/11/20254/4/2025YesNoWarning Letter Issued 10/10/2025YesProRx LLC, Exton, PAMark L'Hommedieu 1-904-616-73554/27/202211/22/20249/19/2025YesNoOpen7YesQualgen LLC, Edmond, OKShaun Riney 405-463-41415/23/201512/17/20259/4/2025YesNoOpen7 YesQuantum Pharmaceuticals, LLC, Mounds, OKAlbert Sanchez +479-263-2690; EXT=30621385/30/202411/26/2025Not yet inspectedYesN/AN/AYesQuva Pharma, Inc., Bloomsbury, NJKevin White 1-908-388-10799/15/201712/4/20254/4/2025YesNoOpen7YesQuva Pharma, Inc., Sugar Land, TXSophia Flores 1-832-500-74509/10/201512/2/202510/28/2024YesNoOpen7YesRC Outsourcing, LLC, Lowellville, OHMichael Basista 330-536-850010/7/201511/27/20258/28/2025483NoOpen7YesRight Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop, Irving, TXJeffrey Crouse 1-817-282-93767/3/201911/24/20257/18/2025YesNoRegulatory Meeting Held 1/8/2026YesSankav Pharmaceuticals, LLC, Hackettstown, NJSanjeev K Gupta 1-201-312-85913/21/202512/23/2025Not yet inspectedN/AN/AN/AYesSCA Pharmaceuticals, Little Rock, ARJoanna DiStefano 1-877-550-5059 12/13/201312/5/202510/30/2025YesNoOpen7YesSCA Pharmaceuticals, Windsor, CTJoanna DiStefano 877-550-50598/3/201712/8/202512/20/2024YesNoFMD-145 Letter Issued 4/21/2025YesSignature Rx, Delray Beach, FLDavid Hughes 401-249-196310/13/20231/9/2025Not yet inspectedN/AN/AN/AYesSKNV formerly registered as Sincerus Florida, LLC, Pompano Beach, FLWales H Stoner III 800-604-5032 Ext 3133/10/201612/3/20253/6/2025YesNoUntitled Letter Issued 9/16/2025YesSTAQ Pharma, Inc., Denver, COMark Spiecker 1-303-921-57892/5/201912/18/20252/10/2025NoNoFMD-145 Letter Issued 6/6/2025YesSTAQ Pharma of Ohio, LLC, Columbus, OHMark Spiecker 1-303-921-57891/26/202312/18/20255/16/2025YesNoUntitled Letter and FMD-145 Letters Issued 12/5/2025YesStaska Pharmaceuticals, Inc., Bennet, NELyndon Leitner 402-782-220712/3/202012/12/20259/18/2024YesNoWarning Letter Issued 5/5/2025YesStokes Healthcare Inc., dba Epicur Pharma, Mt. Laurel, NJMichael Tursi 888-508-50321/30/201811/19/20255/23/2025YesNoOpen7YesTailstorm Health Inc., Chandler, AZMitesh Gandhi 480-274-861710/23/201912/6/20255/23/2025YesNoRegulatory Meeting Held 11/18/2025YesTailstorm Health Inc., Phoenix, AZMitesh Gandhi 480-274-861710/23/201912/2/202511/14/2025YesNoOpen7YesTomorrowmed Pharma, LLC, Morrisville, NCSean Hatfield +1-919-747-322211/22/202411/22/2024Not yet inspectedN/AN/AN/AYesTurbare Manufacturing, Conway, ARDeketric Smith 501-504-66356/23/202312/3/20251/24/2025YesN/AWarning Letter Issued 9/16/2025YesUniversity of Tennessee, Memphis, TNHarry Kochat 901-448-14405/19/202412/12/2024Not yet inspectedN/AN/AN/AYesUS Specialty Formulations LLC, Allentown, PAKyle Flanigan 610-849-50231/31/201412/3/20256/28/2024YesNoOpen7YesVitae Enim Vitae Scientific, Inc., San Diego, CABoris Gites 858-222-07461/2/202412/29/2025Not yet inspectedN/AN/AN/ANoVitalRx Pharmacy, LLC, Houston, TXLinda Sarpong 1-832-259-13628/27/20241/3/2026Not yet inspectedN/A N/A N/A YesWedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CAPaul Yamamoto 669-297-08571/31/201411/25/20257/3/2025YesNoOpen7YesWedgewood Connect Ohio, LLC, Albany, OHJamie Grubb 1-800-216-500510/19/202312/16/2025Not yet inspectedN/AN/AN/AYesWells Pharma of Houston, LLC, Houston, TXCarissa Imrecke 1-346-888-10103/9/202012/3/20253/28/2025YesNoWarning Letter Issued 11/7/2025YesWells Pharmacy, Inc., Dyersburg, TNMelissa Stefko 800-622-45106/7/201611/28/20254/25/2025YesNoUntitled Letter Issued 10/14/2025YesWhite Label Pharmacy dba Nova Pharmacy, Katy, TXAdedoyin Ezekwesili 833-789-330512/16/202512/16/2025Not yet inspectedN/AN/AN/AYesWesley Pharmaceuticals, Orlando, FLMark Mikhael 1-407-440-15557/25/202511/22/2025Not yet inspectedN/AN/AN/AYesWilcrest Pharmaceuticals, Inc., Houston, TXTowobola Louis 1-713-277-41143/13/202512/2/2025Not yet inspectedN/AN/AN/AYesWillowbend Pharma Select, LLC, Houston, TXBasil Raad 832-628-32604/11/202412/12/2025Not yet inspectedN/AN/AN/AYesXseer Pharmaceuticals, Inc., Los Angeles, CAAli Khosrovni 310-606-014610/21/202312/25/2025Not yet inspectedN/AN/AN/AYes Notes The "initial date of registration as an outsourcing facility" is the date the facility was first registered (i.e., the date FDA determined that the initial registration information submitted for the facility was complete, and the establishment fee was paid in full). Under section 503B(b) of the FD&C Act, after the initial registration, a facility that elects to continue to be registered with FDA as an outsourcing facility must re-register annually. A facility that elects to register (or re-register) with FDA as an outsourcing facility must pay an annual establishment fee. The “date of most recent registration as an outsourcing facility” reflects the date FDA determined the most recently submitted registration information was complete and the annual establishment fee for that fiscal year paid in full. Unless a previously registered outsourcing facility re-registers and pays the annual establishment fee in full during the registration period (between October 1 and December 31 of each calendar year), the facility will be removed from the list of registered outsourcing facilities on January 1 of the next calendar year. Once an outsourcing facility is registered, the facility will be added to the list of facilities FDA intends to inspect according to a risk-based schedule. FDA plans to inspect outsourcing facilities within a reasonable period of time following initial registration, once it is confirmed that the facility has initiated drug production and distribution. However, the exact timing of the inspections can be affected by a number of variables, including the number of outsourcing facility registrants, other inspection priorities, and the operational status of the newly registered outsourcing facility. Inspections identified in this table are associated with the facility at the listed address. A company may own or operate more than one registered outsourcing facility. FDA’s web page Compounding: Inspections, Recalls, and other Actions may contain information about compounding facilities under the same ownership as the listed registered outsourcing facility. Inspections may take place over several days, weeks or longer. The date of the inspection is the date a Form FDA 483 listing the investigators’ observations was issued. If no FDA Form 483 was issued, the date is the last day of the inspection. A Form FDA 483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final agency determination of whether any condition is in violation of the FD&C Act or any relevant regulations. This table does not include State Board of Pharmacy actions, if any. To determine whether a registered outsourcing facility has been the subject of a state enforcement action, check with the State Board of Pharmacy for the state in which the facility is located. Some states post disciplinary or other actions on their web sites. “Closed” means the inspection has been closed without further action. “Open” means FDA has not determined whether further action will be taken. If an action has been taken, it will be listed. Possible FDA actions include warning letter, seizure or injunction. The information in this column was provided by the registered outsourcing facility at the time of registration and has not been verified by FDA. “N/A” indicates the registered outsourcing facility has not provided this information. This outsourcing facility was the subject of at least one previous inspection relating to compounding that resulted in a Form FDA 483, warning letter or other action. For information about such inspections and resulting actions, visit Compounding: Inspections, Recalls, and other Actions. A remote regulatory assessment (RRA) is an examination of an FDA-regulated establishment and/or its records, conducted remotely, to evaluate compliance with applicable FDA requirements. These assessments assist in protecting human and animal health, inform regulatory decisions and verify certain information submitted to the agency. Based on inspectional findings, the inspection revealed significant issues. As a result, the outsourcing facility may have either initiated a recall on their own following conversation(s) with the FDA investigator or FDA recommended a recall at the conclusion of the inspection or both. Additionally, the outsourcing facility may have conducted multiple recalls or recalled multiple drugs.

FDA Pilots Faster Clarifications to Meeting Minutes

The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. Through the program, sponsors are given a “Meeting Minute Clarification Opportunity” which gives them the opportunity to obtain a quick clarification of a response from a single discipline. “In this industry, time is a precious commodity. Numerous drug developers have told me that a quick touchpoint or clarification opportunity with the FDA team could spare them months of guesswork,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Our goal is to give sponsors prompt, clear feedback so they can focus on what they do best: delivering more cures and innovative treatments to the American people.” Specifically, sponsors will be able to submit a question via email and agency staff will aim to respond within three business days by email. Since the pilot launched in October, the agency has provided several helpful clarifications to sponsors following receipt of FDA meeting minutes. The program is being piloted by the FDA’s Office of New Drugs and is part of the agency’s broader initiative to streamline the drug development process and improve agency interactions with sponsors. The agency intends to expand these practices across FDA centers. ###

[Clinical Picture] Uncovering culture-negative endocarditis with miliary embolic brain abscesses

A 14-year-old girl with no previous medical history presented to the emergency department of the Children's Hospital of Illinois (Peoria, USA) with a seven-day history of high-grade fevers, fatigue, abdominal and back pain, and headaches, preceded by several months of nonspecific fatigue. She had body aches, bilateral neck pain without nuchal rigidity, photophobia, abdominal tenderness, myalgias, and cervical lymphadenopathy. Her cardiac examination was typical and an infectious workup was negative, including blood cultures, comprehensive serologies for toxoplasmosis, histoplasmosis, tuberculosis, bartonellosis, cysticercosis, tick-borne illnesses, fungal, viral, and parasitic infections.

[Grand Round] First human infection and management of Versteria rafei infection restricted to the liver with phylogenetic analysis in the context of known cases

A recently described cestode genus, Versteria, has been implicated in disseminated human disease in North America. We report the first known case of infection with a recently reported species, Versteria rafei, localised to the liver with attempted surgical resection. Through review of other patients known to be infected with this parasite, we established that this is a rare zoonotic infection involving contact with minks and mustelids. Although Versteria belongs to the same family as Echinococcus, there are several important differences.

[Personal View] The participation of people deprived of liberty in tuberculosis vaccine trials: should they be protected from research, or through research?

People deprived of liberty are among the populations experiencing the highest rates of tuberculosis. Prisons typically create ideal conditions for Mycobacterium tuberculosis transmission, including overcrowding and prolonged exposure in poorly ventilated environments, and often have populations at high risk of developing disease. The development of a novel, effective tuberculosis vaccine to prevent adult pulmonary tuberculosis is considered a crucial objective for improving tuberculosis control and, ultimately, elimination.

[Review] Resurgence of human metapneumovirus in the post-COVID-19 era: pathogenesis, epidemiological shifts, clinical impact, and future challenges

Human metapneumovirus (hMPV), a respiratory pathogen identified in 2001, is a substantial cause of community-acquired respiratory infections across all age groups. This Review explores the impact of hMPV after the COVID-19 pandemic, emphasising its resurgence as a public health concern. Epidemiological shifts, as well as unusual seasonal patterns, increased co-infection rates, and altered age distributions, have been observed globally. Phylogenetic analysis has shown the variation across three distinct periods, especially before and after the COVID-19 pandemic, in terms of genotypic distribution.

[Review] Management of individuals exposed to multidrug-resistant or rifampicin-resistant tuberculosis

Individuals exposed to a person with infectious multidrug-resistant or rifampicin-resistant (MDR-RR) tuberculosis are at risk of developing tuberculosis disease. Historically, insufficient empirical evidence for preventive treatment in this group has permitted inadequate guidance for clinical decision making. However, several high-quality studies have been published detailing preventive treatment options for these contacts at high risk. In this Review, we discuss the management of individuals exposed to patients with infectious MDR-RR tuberculosis.

[Articles] Human papillomavirus (HPV) type 16 and type 18 antibody concentrations after a single dose of bivalent HPV vaccine in girls aged 9–14 years compared with three doses of quadrivalent HPV vaccine in women aged 18–25 years in Costa Rica (PRIMAVERA): a non-randomised, open-label, immunobridging, non-inferiority trial

Non-inferior antibody responses for the single-dose bivalent HPV vaccine were seen for HPV-18 but not HPV-16, which would be insufficient evidence to motivate regulatory change, even though seropositivity approached 100% in the follow-up phase and the observed antibody concentrations were similar to protective levels seen in previous trials. Trials that directly evaluate protection afforded by single-dose HPV vaccination against persistent HPV infection will definitively address the level of protection afforded by single-dose HPV vaccination.

[Articles] Estimating measles susceptibility and transmission patterns in Italy: an epidemiological assessment

Unvaccinated adults contribute substantially to measles transmission in Italy. Heterogeneous immunity gaps exist across regions, with some regions showing persistently low vaccine uptake in children and other regions showing a high proportion of susceptible adults. These results emphasise the need for tailored vaccination strategies, including catch-up campaigns for adults. By integrating routine surveillance data with modelling techniques, this study presents a resource-efficient approach to quantifying immunity and transmission risks, providing a scalable framework for countries aiming to refine their immunisation policies.

[Articles] Efficacy and safety of obeldesivir in low-risk, non-hospitalised patients with COVID-19 (OAKTREE): a phase 3, randomised, double-blind, placebo-controlled study

Obeldesivir was generally safe and well tolerated, with greater reduction of SARS-CoV-2 viral RNA copy number versus placebo at day 5. However, obeldesivir did not significantly reduce time to symptom alleviation, possibly reflecting the challenges of assessing efficacy in this population in an era of high rates of vaccine-induced and natural immunity.

[Media Watch] In the maraña of leishmaniasis

During Colombia's protracted armed conflict, soldiers commonly described the rainforest in which they were deployed as maraña (the Spanish word for tangle), encapsulating the feeling of being entangled within the dense foliage of the jungle. In Maraña: War and Disease in the Jungles of Colombia, Lina Pinto-García uses the metaphor of maraña to describe how the armed conflict and cutaneous leishmaniasis—a non-lethal, skin vector-borne disease presenting as rounded, hollowed-out skin sores—have also become intertwined.

[Media Watch] Vaccines and religion in Zimbabwe

Religion and COVID-19 Vaccination in Zimbabwe, edited by Tenson Muyambo, Fortune Sibanda, and Ezra Chitando, is an in-depth look into the responses of churches and religious leaders to vaccines during the COVID-19 pandemic, as well as their interactions with and reactions to the policies and restrictions from the Zimbabwean Government and other health actors. Various contributors provide perspectives into the beliefs and responses of different religious groups in Zimbabwe and discuss the cultural factors that affected them.

[Profile] Ruanne Barnabas—promoting evidence-based equity

Ruanne Barnabas grew up in Durban, South Africa, during a time of “deep inequity in health, opportunity, and justice”. Motivated by her parents and teachers, she decided to study medicine because it “felt like the perfect balance between reason and compassion”. In medical school, Barnabas was inspired by clinicians and researchers working on the frontlines of the HIV epidemic, “especially those who combined rigorous science with a deep commitment to human dignity”. However, Barnabas soon realised that exceptional individual care was not enough to bring about macro-level changes for disadvantaged communities.

[Profile] Deniz Gökengin—responding to HIV/AIDS in Türkiye

Deniz Gökengin thinks colleagues view her as “a very serious, hardworking, meticulous, control-freak type of person”. But she has another side. “I am very compassionate. I have a lot of compassion for people in need, animals, the environment, plants, and the world. So my inner and outer shells are different, but I think they complement each other”, she says. Gökengin is a professor of infectious diseases in the Department of Infectious Diseases and Clinical Microbiology at Ege University, Izmir, Türkiye.