Pharmacy Regulatory Compliance

Oberman Law Firm has the expertise to successfully guide clients through the complex regulatory environment and the overlapping federal and state regulations that impact the pharmacy industry.

Pharmacies must comply with the pharmacy acts and board of pharmacy regulations of each state in which they operate. State requirements for the prescribing and dispensing of prescription drugs and other elements of pharmacy operations can be highly technical and may vary significantly from state to state. Moreover, state laws are frequently amended, which requires clients to stay abreast of the rapidly changing pharmacy regulatory environment.

When handling drugs that have been classified as controlled substances, another layer of regulation applies. The federal Controlled Substances Act (CSA) is implemented by the Drug Enforcement Administration (DEA) through comprehensive regulations that cover all aspects of the manufacturing, ordering, receipt, storage, distribution, prescribing, dispensing, and destruction of controlled substances. The CSA and the DEA regulations, however, do not preempt state laws relating to controlled substances. Most states have enacted their own controlled substance acts and regulations, which can also vary widely by state.

Pharmacies must also comply with HIPAA and various other state and federal privacy and security provisions. Various aspects of pharmacy practice are also impacted by the Food and Drug Administration (FDA) regulations and analogous state laws that govern pharmaceuticals and over-the-counter drugs, including laws relating to pedigree, reporting obligations, the federal Prescription Drug Marketing Act, and state laws pertaining to promotion and advertising.

Oberman Law Firm has a team of professionals drawn from multiple practice areas who are experienced in the regulation of the pharmacy industry. Our Firm has experience at all levels of the distribution chain, including active ingredient and pharmaceutical manufacturers and distributors; retail, mail order, specialty, Internet pharmacies; and physician groups. We have counseled clients on compliance, conducted internal investigations and compliance reviews, and worked with clients to modify systems, policies and procedures, and training materials to satisfy regulatory requirements.