Town & Country Compounding is a 503A ACHC accredited sterile and non-sterile compounding pharmacy lab. We are accredited in USP 795 and 797 compounding as well as USP 800 for both USP 795/797. Our new state of the art pharmacy compounding laboratory was designed to enhance our capabilities working in clinical studies.
T&C is one of only 2% of compounding pharmacies nationwide who have achieved PCAB accreditation
With over 25 years of compounding experience, John Herr is considered to be one of the experts in the compounding industry.
Town & Country Compounding Pharmacy is often asked to participate in the various phases of drug research and development. This may include developing new drugs or using new combinations or doses of existing drugs.
Source: FDA
We work with the pharmaceutical company, university and others in this initial research phase to ensure the stability, delivery method, concentration, dosage, pH, packaging, labeling, quality and accuracy of the drug being studied prior to proceeding to the different phases of the clinical trial.
Town & Country Compounding has years of experience with clinical trials. We have helped with the development of IND, NDA and ANDA drugs. Our team often assists the researcher or manufacturer with suggestions to the development of the study plan and/or research protocol before the clinical trial begins.
Town & Country Compounding has participated in studies and clinical trials for many types of active ingredients, combination drugs, and various dosage forms including but not limited to:
We work with the statistician and the statistician’s randomization code to ensure both the active pharmaceutical ingredient and the placebo are properly blinded to all clinical investigators. We also work with the client to develop the proper labeling for the study. As required by the FDA ,we enter all patients and or subject ID numbers into our pharmacy dispensing system as a unique group of subjects for the trial. This ensures if there is a need to perform a recall, we have traceability of what the subjects in the trial have received.
We take pride in working with your team from initial development of the study or trial and through all aspects of the study or trial up until completion.
Bring your product to market more quickly and less expensively.
In the DOSA, the FDA distinguishes between 503A (compounding pharmacies) and 503B (pharmaceutical manufacturers) facilities.
Unlike 503B facilites,section 503A exempts compounding pharmacies from having to follow the FDA’s cGMP regulations as outlined in 21 CFR Part 211 and 21 CFR Part 210.
Instead, 503A pharmacies must follow the regulations set by the USP (United States Pharmacopeia ) Compounding Compendium and the NF (National Formulary)
