• 866-466-4284
  • PAC Auditing Solutions 1055 Howell Mill Rd, Suite 800, Atlanta, GA 30318

We Audit Your Suppliers, So You Don't Have To

Request a Supplier Audit

Compounding

Registered Outsourcing Facilities
Success Image

What is compounding?

Success Image

What is a facility as defined for 503B – Outsourcing Facility?

Success Image

What are the current regulatory guidelines for compounding facilities?

Recent Guidance and Regulatory Actions for Outsourcing Facilities

 
Text of Compounding Quality Act
Safety Alert - Compounded Moxifloxacin (TASS)
Temporary Compounding of Certain Drugs (During the COVID-19 Public Health Emergency)
Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders
Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products
cGMP Draft Guidance for 503Bs (Updated January, 2020)
FDA in brief: FDA Seeks Comment for Nine Bulk Substances
Bulk Drug Substances Used in Compounding
Compounding Policy: Compounding of 5-HTP for Patients with BH4 Deficiency
FDA Warns Users Re: Pacifico National dba AmEx Pharmacy
Compounding Risk Alert: L-glutathione by Letco
PharmD Solutions: Consent decree
PharMEDium: Consent decree
April, 2019: Statement from Commissioner
Federal Register: List of Bulk Drugs Substances, Clinical Need (503B)
FDA in Brief: final decision on two substances
Final Guidance: Evaluation of Bulk Drug Substances
2018 Compounding Priorities Plan
Public Meeting; Request Comments
Dec , 2018: Statement from Commissioner
Insanitary Conditions at Compounding Facilities
Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities
Memorandum of Understanding (MOU) between FDA and States
Compounded Drugs Essentially a Copy

SEND US YOUR INQUIRIES

In order to access our report library you must be subscribed to our services. To get information about subscribing please fill out the form and click submit:

REPORT INQUIRY

You can get user access by filling up the form

Someone will contact you within 48 hours





Report Inquiry

[recaptcha]

AnazaoHealth Corporation, Las Vegas, NVANNOVEX PHARMA, INC, Lorton, VAApollo Care, Columbia, MOASP Cares, San Antonio, TXAthenex Pharma Solutions, LLC, Clarence, NYAtlas Pharmaceuticals, Phoenix, AZBayCare Integrated ServiceCenter, LLC dba BayCare Central Pharmacy, Temple Terrace, FLBelcher Pharmaceuticals, LLC, Largo, FLBennett Pharmaceuticals of America LLC, Hudson, WIBPI Labs, LLC, Largo, FLBrookfield Medical/Surgical Supply, Inc., Brookfield, CTBSO LLC, Lakewood, COCentral Admixture Pharmacy Services, Inc., Allentown, PACentral Admixture Pharmacy Services, Phoenix, AZCentral Admixture Pharmacy Services, Inc., San Diego, CADelta Pharma, Inc., Ripley, MSDenver Solutions, LLC dba Leiters Health, Englewood, CODenver Solutions, LLC, dba Leiters Health, Buena, NJEagle Pharmacy, Inc., Hoover, ALEmpower Pharmacy, Houston, TXExcite Pharma Services, LLC, Lee's Summit, MOExela Pharma Sciences, LLC., Lenoir, NCF.H. Investments, Inc., DBA Asteria Health, Birmingham, ALFagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KSFarmakeio Outsourcing LLC, Southlake, TXFresenius Kabi Compounding, LLC, Canton, MAGenixus, Corp, Kannapolis, NCHikma Injectables USA Inc., Dayton, NJHikma Pharmaceuticals USA Inc., Cherry Hill, NJHybrid Pharma, LLC, Deerfield Beach, FLImprimis NJOF, LLC, Ledgewood, NJIntegraDose Compounding Services, LLC, Minneapolis, MNKRS Global Biotechnology, Inc., Boca Raton, FLLeesar Inc., Fort Myers, FLMark Cuban Cost Plus Drug Company, PBC, Dallas, TXMcGuff Outsourcing Solutions, Inc. Santa Ana, CAMedi-Fare Drug, Blacksburg, SCMedisourceRx, Los Alamitos, CAMolecular PharmaGroup, New Providence, NJNephron Sterile Compounding Center, LLC (NSCC), West Columbia, SCNew England Life Care, Inc., dba: Advanced Compounding Solutions, Woburn, MANubratori, Inc., Torrance, CAOlympia Compounding Pharmacy, Orlando, FLOurPharma, LLC, Fayetteville, ARPharmaceutics International, Inc., Cockeysville, MDPine Pharmaceuticals, LLC, Tonawanda, NYPQ Pharmacy LLC, Brooksville, FLPrimera Compounding, LLC, Rosenberg, TXPrisma Health Outsourcing Facility, Simpsonville, SCProRx LLC, Exton, PAProvidence Health & Services-Washington, Tukwila, WAQualgen LLC, formerly registered as Amerilab LLC, Edmond, OKQuVa Pharma, Inc., Bloomsbury, NJQuva Pharma, Inc., Sugar Land, TXQuVa Pharma, Inc., Temple, TXRight Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop, Irving, TXRXQ Compounding LLC, Albany, OHSCA Pharmaceuticals, Little Rock, ARSCA Pharmaceuticals, Windsor, CtSKNV formerly registered as Sincerus Florida, LLC, Pompano Beach, FLSSM Health Care Corporation, Fenton, MOSTAQ Pharma, Inc., Denver, COSTAQ Pharma of Ohio, LLC, Columbus, OHStaska Pharmaceuticals, Bennet, NESterRx, LLC, Plattsburgh, NYStokes Healthcare Inc. dba Epicur Pharma, Mt. Laurel, NJTailstorm Health Inc., Chandler, AZTailstorm Health Inc., Phoenix, AZThe Ritedose Corporation, Columbia, SCUS Specialty Formulations LLC, Bethlehem, PAWedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CAWells Pharma of Houston, LLC, Houston, TXWells Pharmacy, Inc., Dyersburg, TN

Loading...