STELLAR PRODUCTS THROUGH STRICT COMPLIANCE
Compounded medications contain unique National Drug Codes (NDC)
- Pharm D. Solutions is registered as manufacturer with the FDA. In addition to a lot number, each of our medications is assigned a unique NDC number. This allows the FDA to keep track of types of compounds we are creating at our facility as well as the ingredients we are using on a semiannual basis.
- We meet or exceed regulatory requirements issued by state and federal agencies
- We meet or exceed USP <797> requirements for compounded sterile preparations
- We are also registered with FDA as 503b outsourcing facility. We voluntarily invite the FDA to inspect our facility at random for adherence to Good Manufacturing Practice standards.
- Additionally, our facility is registered with the DEA as a manufacturer, rather than "re-labeler." The requirements for this type of license are far more stringent compared to that of a regular non-sterile compounding pharmacy.
- Custom label design that is easy to read and complies with industry standards
- Our label designs incorporate tall man lettering to reduce medical and administrative errors.
- Labels are color coded and designed according to ASTM standards. Our team will work with your facilities to find the right label color to match your protocols.
- Bar codes on labels will highlight important information regarding the medication such as the name of medication, NDC, and lot number. We can add information to the bar code at your request.
- Product liability insurance coverage
- Pharm D. Solutions maintains product and professional liability coverage for the services we provide to our customers. If necessary, we will obtain "Tail Coverage" in the event it is necessary.
- Facility inspection
- Pharm D. Solutions offers current and potential clients the opportunity to tour our facility for a thorough inspection. If you would like to set up an inspection appointment, please contact us at any time.