Remove 2018 Remove Compounding Remove Controlled Substances
article thumbnail

How API CMOs can improve containment capabilities without facility acquisition

Pharmaceutical Technology

According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities. However, site selection and facility acquisition can be a challenge, as well as being a major capital expenditure (CAPEX).

article thumbnail

DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic Outcomes

FDA Law Blog: Biosimilars

Palmer — For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. 2] Why is this an issue? However, two events conspired to undermine this prior guidance.