Overview
Statues are...
passed by legislatures and then an executive person such as the president or governor has to approve those statues.
SBOP
(State Board of Pharmacy) Stage agencies that register and regulate pharmacy facilities, pharmacists, and pharmacy technicians
CDC
Centers for Disease Control and Prevention
Federal agency
Charged with protecting public health and safety through the investigation, identification, prevention, and control of diseases
Various institutes and centers operate under CDC oversight.
Misbranded
drug that is misleadingly or fraudulently labeled (focuses on representations made by the manufacturer)
Kefauver-Harris Amendment of 1962
Also known as the Drug Efficacy Amendment
Prompted by the thalidomide disaster of 1962
Regulations...
clarify statutes, but they do not change them. They have the force of the law.
National Association of the Boards of Pharmacy
Assist the boards of pharmacy by making sure there are consistent standards among each state board
CMS
Centers for Medicare and Medicaid Services
Regulates administration of Medicare, Medicaid, the State Children's Health Insurance Program (SCHIP), the Health Insurance Portability and Accountability Act (HIPAA), the Clinical Laboratory Improvement Amendments (CLIA), and several other health-related programs
Conducts inspections to ensure compliance with its guidelines
Adulterated
altered and causing an undesirable effect (focuses on the physical conditions of the drug or device)
Poison Prevention Packaging Act
Required that medications had child-proof packaging.
Exceptions to this are nitroglycerin sublingual tablets and birth control pills, potassium effervescent tablets, and specific corticosteroid tablets
State pharmacy law vs. Federal pharmacy law
If federal and state pharmacy-related laws conflict, the more stringent law is applied.
FDA
Food and Drug Administration
protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, food, and cosmetics.
They must approve all medications before pharmacies can sell them in the U.S.
They oversee the regulation of products. If there is a problem they can inform the manufacturer, pharmacy, and general public.
They regulate the advertising and labeling of all prescription and OTC medications.
They require that all medications come with patient package inserts and requires all pharmacies to provide medication guides for medications that have black box warnings.
TJC (formerly JCAHO)
The Joint Commission (formerly Joint Commission on Accreditation of Healthcare Organizations)
Evaluates and accredits nearly 15,000 U.S. health care organizations and programs
Food, Drug, and Cosmetic Act of 1938 (FDCA)
Labeling requirements
Labeling Requirements for dispensed prescriptions include:
Pharmacy Name and Address
Serial Number (Rx Number)
Date of fill
Expiration Date
Prescriber’s name
Patient’s name
Directions for use
Cautionary statements
These meds should also have a package insert with them
Comprehensive Drug Abuse Prevention and Control Act of 1970
Also known as the Controlled Substances Act of 1970
Established the Drug Enforcement Administration (DEA)
Established five classes, or schedules, for controlled substances based on potential for abuse
State pharmacy law vs. Federal pharmacy law (apply to)
State pharmacy law
Pertains to actual practice
License pharmacies and pharmacy professionals
Determine standards for pharmacy practice
Add restrictions to federal laws, such as food and drug laws
Federal pharmacy law
Pertains to manufacturing, marketing, and distribution of pharmaceuticals
Determines extent to which medical regulations are uniform among the 50 states
DEA
Drug Enforcement Administration
Regulates the legal trade in narcotic and dangerous drugs, manages a national narcotics intelligence system, and works with other agencies to prevent illegal drug trafficking
DEA administrator reports to the director of the FBI.
DEA has offices nationwide and in 40 foreign countries.
They can prosecute offenders that breach legislation
Food, Drug, and Cosmetic Act of 1938 (FDCA)
Caused by and regulated...
Prompted by the sulfanilamide disaster of 1937
Regulated who could prescribe legend (prescription-only) drugs
Food, Drug, and Cosmetic Act of 1938 (FDCA)
OTC must include...
Over-The-Counter (OTC) medications must include the following information on their label:
Product name
Name and address of the manufacturer and distributor and name of the person or place that repackages the product and others in the chain of commerce.
Established name of all inactive or active ingredients and the quantities of certain other ingredients
Net contents
Required cautions and warnings
Name of any potentially habit-forming drug contained in the formula
Adequate directions for use or consumption.
Registration for Controlled Substances:
Pharmacies that dispense controlled substances have to file a form 224 with the DEA and they have to renew this every 3 years
Patient’s Bill of Rights
Established by each state
Outlines patient's proper expectations regarding quality of care, privacy, and individual health care provider's responsibilities
Health care providers and facilities must provide all patients with access to a written copy of the patient bill of rights
OSHA (1970)
Occupational Safety and Health Administration
Ensures the safety and health of America's workers by setting and enforcing standards
Pure Food and Drug Act of 1906
Provided for federal inspection of meat products
Forbade manufacture, sale, or transport of adulterated food products or poisonous patent medicines (focused on purity of products)
But this act did NOT:
Cover cosmetics
Provide the authority to ban unsafe drugs
Prohibit false statements about drugs
Require labeling to identify product contents
there were no requirements to list active ingredients, directions for use, warnings, or safety concerns on labels
Durham-Humphrey Amendment of 1951 (AKA: Prescription Drug Amendment)
Required prescription drugs to bear the legend, "Caution: Federal law prohibits dispensing without a prescription"
Later amendments approved a substitute legend that reads "Rx only“
Also gave permission for medications to be made over the phone
Ordering, Receiving, and Documentation Requirements
To order Schedule II meds, the pharmacy must fill out a form 222. It is a triplicate (top copy goes to the drug supplier, second copy goes to the DEA, and the third copy is kept by the pharmacy )