Chapt 6 Regulatory Standards in Pharmacy Practice Flashcards
A package insert is required to be given to all patients who are taking…
steroids, analgesics, and estrogenic drugs
Which of the following is considered a controlled substance?
Demerol (CII), Morphine (CII), Valium (CIV)
Regulations affecting pharmacy practice encompass…
Federal and state statutes, states rules and regulations, CSA regulations
Which of the following is NOT an approved use of tax-free alcohol?
Beverage purposes.
Which of the following is NOT a responsability of the Food, Drug, and Cosmetic ACT (FDCA)?
Collection of adverse drug reaction reports.
Controlled substances are required by federal law to have appropiate safeguards with their use. Which of the following is NOT an issue?
Patient consent.
Which of the following is NOT a reason to report adverse drug reactions to the FDA?
…
A Class I recall does NOT include…
assigment of the drug recall classification by the FDA.
The intent of the Occupational Safety and Health Administration (OSHA) is…
To monitor job-related injuries, to develop job safety and health standards, to ensure a safe and healthy workplace
Pharmacy practice standards, guidelines, and statements…
define reasonable and prudent practices.
Durham-Humphrey Amendment
Establishes prescription versus over-the-counter drugs.
Orphan Drug Act
Creates incentives for manufactures to research and develop drugs to treat rare diseases and disorders.
Controlled Substances Act
Regulates the manufacture, sale, and distribution of drugs that have a high abuse potential.
Poison Prevention Packaging Act
Establishes requirements for child-resistant containers.
Hazard Communication Standard
Establishes the rights of employees to know the dangers of substances used in the workplace.
Health Insurance Portability and Accountability Act
Establishes guidelines to protect patient privacy.
RULES and REGULATIONS…
are administrative enactments implemented by government agencies that meet the intent of statutory policies.
The PURE FOOD AND DRUG ACT OF 1906…
… prohibits the adulteration and misbranding of foods in interstate commerce.
The FOOD, DRUG, AND COSMETIC ACT OF 1938…
requires that all new drugs be proven safe and effective
Schedule “ I “…
drugs have no approved medical use in the United States.
The FDA requires distribution of…
.. PATIENT PACKAGE INSERTS (PPIs) to educate patients about the proper use of and potential hazards of drugs.
Federal Statutes
Laws enacted by a legislative body that dictate the conduct of persons or organizations subject to the law.
Rules and Regulations
Promulgated by government agencies at the local, state, and federal levels.
Food and Drug Administration (FDA)
Promulgates rules, regulations, and standards; inspects drug and food facilities to ensure public safety regarding drug products.
Drug Enforcement Administration (DEA)
A federal agency established to implement the rules and regulations to enforce the Controlled Substances Act (CSA) to combat controlled substance abuse.
Quasi-Legal Standards
Recognized standards that are similar to laws.
Federal vs State Drug Control Laws
Pharmacists are equally responsible for compliance with both federal and state law and respective regulations foverning their pharmacy practice. If the federal law or regulation is more STRINGENT than the comparable state law or regulation, or vice versa, the more stringent law or regulation must be followed.
State Board of Pharmacy
Body established to ensure that the public is well served professionally by pharmacists.
Other responsabilities of the State Board of Pharmacy
Licensing and registering pharmacies.
Delaing with complaints of professional misconduct.
Carrying out disciplinary proceedings.
Developing regulations relating to filling and refilling prescriptions.
Substituting generic and therapeutic drugs.
Labeling.
Performing inspections.
Defining pisons and mandating records to be maintained upon retail sale.
FDCA Regulations
Pure Food and Drug Act of 1906. Food, Drug, and Cosmetic Act of 1938. Durham-Humphrey Amendment of 1951. Kefauver-Harris Amendment of 1962. Medical Device Amendment of 1976. Orphan Drug Act of 1983. Food and Drug Administration Modernization Act of 1997.
Federal Food, Drug, and Cosmetic Act (FDCA)
Federal law through which the Food and Drug Administration promulgates its rules and regulations.
Food, Drug, and Cosmetic Act of 1938
The federal statute through which the FDA promulgates its rules and regulations.
Kefauver-Harris Amendment
An amendmento to the Federal Food and Cosmetic Act that required all new drugs marketed in the United States to be shown to be not only safe, but also efective.
