Health care providers who prescribe and dispense controlled substances (Schedule II to Schedule V) must comply with the stringent federal and state requirements that regulate the prescribing and dispensing of these substances (see DEA Practitioner’s Manual and DEA Pharmacist’s Manual). Failure to comply with these rules may trigger an investigation or audit that will not only carry monetary fines but also threaten the health care providers’ DEA registration or professional license. Mr. O’Quinn, as a pharmacist and attorney, is uniquely qualified and dedicated to helping practitioners, pharmacies, distributors, and other registrants against DEA enforcement actions, and related criminal actions, to protect their licenses, career, and reputation from damage caused by DEA investigations, allegations of noncompliance, and criminal charges.
Mr. O’Quinn advises clients on compliance with Food and Drug Administration (FDA) issues specific to healthcare providers. Many providers are unaware of the extent to which the FDA regulates medical, pharmacy, and healthcare practice. Often, investigations are initiated in response to innocent mistakes or inadvertent compliance issues by healthcare providers or their staff. The purview of the FDA is extremely broad, including investigations of healthcare providers on issues such as illegal diversion of pharmaceuticals, Prescription Drug Marketing Act violations, off-label drug and medical device promotion, fraudulent health treatments/cures/devices, unlawful product substitution, Internet-enabled crimes involving FDA regulated products, illegal importation of regulated products; and illegal manufacture, compounding, sale, or distribution of unapproved products.