Key Terms
What is an Active ingredient
It is the biochemically active component of the drug that exerts a desired therapeutic effect.
DQSA
Streamlines the compounding process for pharmacies and establishes standards for compounding and outsourcing facilities.
What is the Orphan Drug Act
Encourages the development of drugs for rare diseases by providing incentives like tax credits and exclusivity for manufacturers.
MMA
Introduces changes to Medicare, including prescription drug benefits and incentives for beneficiaries to enroll in plans.
What is KG
Kilograms
Kefauver-Harris Amendment
Strengthens drug approval processes by requiring evidence of efficacy and safety, following the thalidomide tragedy.
What is ADR (adverse drug reaction)
It is an unexpected negative consequence from taking a particular drag
HIPAA
Protects patient privacy and secure health information, setting standards for electronic health transactions and data security.
What is Pure Food and Drug Act
Established standards for the purity and labeling of food and drugs, laying the groundwork for later regulatory actions.
What is R
rectally
ACA
Expands healthcare coverage and access, includes provisions for prescription drug benefits, and aims to improve healthcare quality.
DSHEA
Defines dietary supplements and regulates their labeling and safety, providing guidelines for claims manufacturers can make.
What is FD&C Act
Gives the FDA authority to oversee the safety, efficacy, and labeling of food and drugs, including pre-market approval requirements.
Poison Prevention Packaging Act
Mandates child-resistant packaging for household substances to prevent accidental poisoning.
What is ss
half
Controlled Substances Act
Classifies drugs into schedules based on their potential for abuse and establishes regulations for their manufacture and distribution.
Drug Listing Act
Requires manufacturers to register their drugs with the FDA and provide information for a comprehensive drug database.
Durham-Humphrey Amendment
Established the distinction between prescription and over-the-counter medications, allowing for oral prescriptions and refills.
What is the Drug Price Competition/Patent-Term Restoration Act
Facilitates the approval of generic drugs and allows for patent extensions to encourage drug development.
What is teaspoon
Tsp.
Combat Methamphetamine Epidemic Act
Regulates the sale of pseudoephedrine and other ingredients used in the production of methamphetamine, requiring tracking and limits.
What is OBRA-90
Mandates drug utilization review and patient counseling for Medicaid recipients, emphasizing safe and effective medication use.
Patient Safety and Quality Improvement Act
Encourages reporting of healthcare errors to improve patient safety and create a culture of safety in healthcare settings.
Regulatory Bodies
Supervises the legal use of narcotics: DEA
What is without
w/o