DermaTran Health Solutions operates compounding pharmacies serving 47 states. We serve at the request of the doctor, providing an adjunct and sometimes an alternative to traditional oral medications. We comply with all regulations defining non-sterile compounding (USP 795) and as such, we are building on all of the multifaceted principles of both state boards of pharmacy and FDA regulatory compliance. DermaTran is a compounding pharmacy, not a manufacturer. We compound individual prescriptions one by one as we work with individual doctors to assist in treating a specific patient’s pain. Through this approach, we apply the use of the patient-doctor-pharmacist Triad in all medical and business practices.
DermaTran does not make claims regarding the effectiveness of the medications that it compounds for patients. Similarly, we do not claim to be superior to any other treatment modality or compounder. We simply believe that our scientific approach and our processes are excellent in and of themselves.
The following regulations from the FDA Compliance Policy Guide are some of the principles with which DermaTran Health Solutions complies.
By regulation, compounding pharmacies are to refrain from:
- Compounding drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions.
- Compounding drugs that were withdrawn or removed from the market for safety reasons.
- Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without an FDA sanctioned investigational new drug application in accordance with 21 U.S.C. 355(i) and 21 CFR 312.
- Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA-registered facility.
- Receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements.
- Using commercial scale manufacturing or testing equipment for compounding drug products.
- Compounding drugs for third parties who resell to individual patients or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale.
- Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products. In certain circumstances, it may be appropriate for a pharmacist to compound a small quantity of a drug that is only slightly different from an FDA-approved drug that is commercially available. In these circumstances, FDA will consider whether there is documentation of the medical need for the particular variation of the compound for the particular patient.
- Failing to operate in conformance with applicable state law regulating the practice of pharmacy.