Pharmacy Regulatory
Compliance
King & Spalding has the expertise to successfully guide clients through the complex King & Spalding’s
regulatory environment and the overlapping federal and state regulations that impact Healthcare Practice
the pharmacy industry. was one of seven
finalists nationally
Pharmacies must comply with the pharmacy acts and board of pharmacy regulations
for the Chambers
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
USA 2013 Award
highly technical and may vary significantly from state to state. Moreover, state laws for Excellence.
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.
Failure to comply with pharmacy and controlled substance laws and regulations can
result in civil and administrative penalties, suspension or revocation of licensure, and
even criminal sanctions.
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.
Additionally, pharmacy reimbursement is subject to specific and highly technical
rules and regulations. Individual state Medicaid programs, Medicare Part B and Part
D, and other government programs have comprehensive regulations governing issues
such as provider participation, claims submission, reimbursement limits, and
overpayment disclosure and repayment. Federal and state prosecutors and individual
qui tam plaintiffs are becoming more aggressive in bringing suits against pharmacies
Pharmacy Regulatory Compliance [Link]
for failure to abide by these requirements. Liability under the False Claims Act, the Anti-
Kickback Statute, and related state provisions can result in significant civil penalties,
enhanced compliance obligations, and potential exclusion from participation in government
healthcare programs.
King & Spalding has a team of professionals drawn from multiple practice areas who
specialize in the regulation of the pharmacy industry. Our pharmacy team members have
experience at all levels of the distribution chain, including active ingredient and
pharmaceutical manufacturers and distributors; retail, mail order, specialty, long-term care
and Internet pharmacies; hospitals and clinics; and physician groups. We have counseled
clients on compliance, conducted internal investigations and compliance reviews, and
Chambers USA worked with clients to modify systems, policies and procedures, and training materials to
recognized King satisfy regulatory requirements. Our lawyers have handled criminal, civil, and
& Spalding’s administrative regulatory matters involving the DEA, FDA, state controlled substance
Healthcare Practice agencies and boards of pharmacy, and they have litigated related proceedings in federal and
state trial courts and courts of appeals.
as “home to some of
the best legal minds Representative Clients and Matters
in the practice of • Serving as lead trial counsel for a Fortune 100 healthcare company in administrative
healthcare law.” proceedings before the DEA as well as in related federal district and appellate court
litigation.
• Serving as lead counsel in False Claims Act investigations and litigation involving alleged
improper pharmacy billing to Medicare Part D, Medicaid and other healthcare programs.
• Conducting an internal investigation for a major national retail pharmacy chain related to
drug substitution requirements.
• Conducting a compliance review of a Fortune 100 retail pharmacy to assess the
effectiveness of the company’s policies, procedures, and monitoring programs in meeting
federal and state regulatory obligations.
• Conducting a compliance review of a national mail order pharmacy to assess compliance
with federal and state pharmacy and controlled substance laws.
• Developing a multistate pharmacy regulatory database for use by in-house legal and
operations personnel that provides a plain language summary of state and federal
requirements for a range of key topics.
• Advising a Fortune 100 pharmacy retailer regarding the development of internal systems
and controls relating to implementation of regulations allowing the electronic prescribing
of controlled substances.
• Advising a national pharmacy chain regarding various state Medicaid agency requirements
Contact for coordination of benefits billing.
Catherine M. O’Neil • Providing advice to a coalition of more than 50 pharmaceutical, medical device, and
+1 404 572 2704 biotechnology companies regarding compliance with state marketing code of conduct, gift
coneil@[Link] prohibition, marketing cost disclosure, drug price reporting, and prescriber data privacy
laws.
Seth Lundy • Representing an industry working group of two dozen pharmaceutical companies in the
+1 202 626 2924 implementation of FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) for
slundy@[Link] long-acting opioids.
• Assisting a healthcare company with the implementation and operation of 340b drug
Shannon F. Cox pricing program.
+1 404 572 4805 • Advising pharmacy clients regarding the implementation of processes, policies, and
scox@[Link] procedures for sale of pseudoephedrine and other listed chemicals.
• Advising pharmacy and hospital clients with regard to state and federal regulations
Stephen P. Cummings governing storage and disposal of pharmaceuticals and hazardous waste.
+1 404 572 2753 • Conducting internal reviews of a client’s policies and procedures governing pharmacy use
scummings@[Link] of social media and other patient communications.
In some jurisdictions, this may be considered “Attorney Advertising.” 1210201542736746
