National Oversight Agencies and Organizations
We need federal and state government agencies, along with nongovernmental organizations, to ensure that the regulations required to fill the previous mentioned laws are up to date, reviewed and enforced
Food and Drug Administration
The FDA’s Office of Medical Products and Tobacco oversees drugs
The practice of pharmacy is most affected by the FDA’s office of the Center for Drug Evaluation and research (CDER):
New drug development and review
Generic drug review
OTC drug review
Post-drug approval activities
The FDA is a “public watchdog” that enforces regulations
The FDA makes sure that there is truth in advertising for both food and drug packaging, labeling, advertising, and marketing
FDA is responsible for the annual publishing of Approved Drug Products with Therapeutic Equivalence Evaluations known as “The Orange Book”. The Orange Book is a reference used in pharmacy to identify all drugs that are approved for both safety and efficacy. Makes sure the generic options are safe substitutes for the brand name drug.
Additional FDA publications:
(1) “The Purple Book”: lists of licensed Biological Products with Reference Product Exclusively and Biosimilarity or Interchangeability Evaluations. It is a guide to approved bioengineered drugs (drugs designed by manipulating genes in living substances to affect the genes in certain patient cells)
(2) “The Green Book”: FDA Approved Animal Drug Products (guide to drugs for use in veterinary medicine)
Drug Enforcement Administration
The DEA is the primary agency responsible for enforcing the laws regarding potentially addictive controlled substances, both legal and illegal
Any entity that is involved with controlled substances must register with the DEA so that it can track the ingredients and control the drugs
They inspect all medical facilities, including pharmacies, where suspicious activity is detected
They work with state drug and narcotic agencies responsible for routine unannounced physical inspections
Investigates issue of unsafe prescribing, dispensing or forging of controlled drug prescriptions. Watches prescribing and dispensing trends.
Can track the flow of narcotics from the manufacturer —> warehouse —> pharmacy —> patient
US Pharmacopeial Convention
An independent, nonprofit, scientific organization
The FDA works with the USP and uses its quality standards for prescription drugs, OTC drugs, and dietary supplements
US Pharmacopeia - National Formulary (USP-NF) is an annual book of standards or compendium. All new drugs approved by the FDA must meet new drugs approved by the FDA must meet USP-NF standards
USP covers: Dietary supplements, homeopathic products, sterile and hazardous compounding standards
National Council for Prescription Drug Programs (NCPDP)
A not-for-profit organization of members in the pharmacy service industry that issues six digit NCPDP Processor ID Numbers (BINS) which pharmacies and pharmaceutical providers use for online electronic records transmissions
Prescribers and pharmacies also have a National Provider Identifier (NPI), a unique 10-digit number, issued by the Centers for Medicare and Medicaid Services for government reimbursement
Pharmacies use these numbers:
In their DEA and FDA interactions
In ordering, purchasing, and tracking their medications
In processing 3rd party prescription claims to insurance
Established industry standards to facilitate online-prescribing and exchanges of health information between pharmacies and medical offices
National Association of Boards of Pharmacy (NABP)
This is the only professional organization that represents all 50 state boards of pharmacy
NABP has developed a model for state practice acts and regulations to help individual state boards of pharmacy build their own regulations
Operates the Verified Internet Pharmacy Practice Sites (VIPPS) which is an accreditation program for internet pharmacies recognized by 17 states. Developed in 1999, it helped patients in the US find legitimate internet pharmacies, protect patient’s privacy, authenticate prescription orders, offer consultation between pharmacies and patients.
State Boards of Pharmacy (BOP)
Governor-appointed leaders from the pharmacy community and consumer representatives make up the membership of each BOP
Governs over hospital, community, retail and other practices
BOP works with the State Department of health and advises legislators on pharmacy law and regulations
Each state board is responsible for overseeing the inspection of all new pharmacies licenses and pharmacy technician licenses
They set the legal pharmacist to pharmacy technicians ratio
They oversee the licenses and certifications of pharmacist and technicians
Occupational Safety and Health Administration (OSHA)
OSHA is an agency of the Department of Labor
Its primary mission is to ensure the safety and health of US workers
Establishes and enforces workplace regulations and standards; provides training, outreach, and education
Encourages continual improvement in workplace safety and health
Pharmacy facilities must follow OSHA legal standards and regulations for their facility and processes, all employees must comply
Center for Disease Control and Prevention (CDC)
A federal agency, under the Department of Health and Human Services, provides guidelines to protect the public from large-scale health issues and illnesses
Works to fight infectious diseases and stop epidemics (regional widespread contagious diseases) and pandemics (globally widespread epidemics)
Focuses on educational awareness of health, disease and addiction prevention and environmental health, disease
Vaccines and preventative prescriptions link pharmacy to the CDC. We also follow CDC guidelines in handwashing and temperatures for vaccine storage.
State Departments and Boards of Health
Each state has a department or board of health to oversee the public health of state citizens. At times they may require the help of pharmacies when we encounter an epidemic or public health threat.
Can establish their own regulations for infectious disease and other health issues