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792 Volume 41, August 2006
Director's Forum
Regulatory compliance is
probably one of the most
important, yet least exhila-
rating, aspects of pharmacy prac-
tice for many pharmacists.
Nonetheless, the profession of
pharmacy, like medicine in gener-
al, is surrounded by regulation
and it is absolutely essential for
every pharmacy director to be
familiar with pharmacy rules,
statutes, standards, and regula-
tions to ensure compliance in all
aspects of operations associated
with medication use.
Regulations are an important
part of practice from drug discov-
ery and investigation to market-
ing, purchasing, and all aspects of
hospital medication use (including
dispensing). In some cases, regula-
tory bodies dictate law that is
enforceable by the local, state, or
federal government (eg, Drug
Enforcement Administration
[DEA]). In other situations, regu-
latory entities set minimum stan-
dards of practice required for
accreditation or participation,
such as the medication manage-
ment standards set forth by the
Joint Commission on Accredita-
tion of Healthcare Organizations
(JCAHO). While, it is impossible
to summarize regulations in one
article, the reference section will
direct you to the most recent doc-
ument or Web site available.
Rather than review the regula-
tions, this article will serve to pro-
vide an overview to regulatory
agencies and their purpose. The
various regulatory bodies are
divided into three broad cate-
gories: federal agencies, state
agencies, and accrediting organi-
zations.
FEDERAL REGULATORY AGENCIES
AND COMPLIANCE
Several US government agen-
cies are responsible for both
implementation and enforcement
of statutes and regulations at the
federal level. Most of these agen-
cies focus on the maintaining high
quality and safety standards for
medications. For example, the
FDA is responsible for the over-
sight of the Federal Food, Drug,
and Cosmetic Act, which regu-
lates the marketing, labeling,
quality, use, and interstate com-
merce associated with drugs and
devices in addition to food and
cosmetics.1Originally passed by
Congress on June 30, 1906, the
Act also addresses misbranding,
safety, efficacy, and inspection
authority and has been complete-
ly rewritten and revised over the
years; the current version was
amended through December 31,
2004.
Another federal regulatory
agency is the Centers for
Medicare and Medicaid Services
(CMS) (formerly known as the
Health Care Financing Adminis-
tration [HCFA]).2This agency is
responsible for administering a
number of federal programs,
including Medicare and Medicaid.
Specifically, the agency is respon-
sible for setting participation
requirements and details related
to drug and procedure coding for
reimbursement. CMS also admin-
isters several other programs,
including the State Children’s
Health Insurance Program
(SCHIP), the Health Insurance
Portability and Accountability Act
(HIPAA), Clinical Laboratory
Improvement Amendments
(CLIA), and advisory jurisdiction
over Consolidated Omnibus Bud-
get Reconciliation Act of 1985
(COBRA). Additionally, CMS is
becoming more involved in the
Hospital Pharmacy
Volume 41, Number 8, pp 792–795
2006 Wolters Kluwer Health, Inc.
Core Competencies in Hospital Pharmacy Practice:
Regulatory Compliance
Michael Sanborn, MS, FASHP*
*Health System Pharmacy Director, Baylor Health Care System, Dallas, TX.
The focus of this Director’s Forum is on regulatory compliance and it
serves as the last in the small series of articles on core practices or com-
petencies in hospital pharmacy practice. Future Director’s Forum topics
will include decentralized pharmacy services, medication safety, clinical
program development, and automation. The goal of the Director’s Forum
throughout 2006 is to provide readers with information on all of the nec-
essary core competencies of hospital pharmacy practice, comprising a
“toolkit” in establishing a patient-centered pharmacy department.
