Regulatory Compliance

compliance

Staying on top of compliance and regulatory matters is a daunting chore for even major pharmaceutical companies employing specialists for this very purpose. The Code of Federal Regulations, Title 21, Part 1300, contains several hundred pages of detailed regulations governing the handling of controlled substances, regulated chemicals and certain drug-making equipment. These regulations, plus applicable case law, define the legal parameters of approximately 1.6 million DEA registrants, most of whom are practitioners and mid-level practitioners authorized to prescribe controlled substances.

Certain provisions of the Federal Food, Drug and Cosmetic Act also regulate controlled substances and their sponsors. DEA and FDA have administrative law authority and frequently issue Final Rules and Orders that, like statutory regulations, have the force of law on regulated entities.

PDRC’s experts begin with a hands-on familiarity with the relevant DEA and FDA regulations pertaining to the manufacture, distribution, prescribing and dispensing of controlled substances. They can quickly and competently answer complex regulatory questions. Moreover, in the rare occasion when a unique situation may call for a unique solution, PDRC is able to contact the appropriate DEA office to obtain additional guidance quickly and confidentially.