Drug Regulation and Control

wofabuli's version from 2016-01-21 00:13

History of Legislation Relating to Drugs

Question Answer
Food & Drug Act 1906Govt pre-approval of drugs required; prohibited interstate commerce in adulterated/misbranded food, drink and drugs
Food Drug & Insecticide Administration 1927Set up law enforcement agency that would be renamed in 1930 as the FDA
Food & Drug Administration 1930Renamed the FDIA to FDA
Food Drug & Cosmetic Act (FDC) 1938Requires new drugs be shown to be safe before marketing
Durham-Humphrey Amendment 1951Defines what drugs require a prescription by a licensed practitioner; requires those drugs to include the legend on their label: "Caution: Federal Law Prohibits dispensing without a prescription" or "Rx only."
Kefauver-Harris Amendment 1962Requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug
Poison Prevention Packaging Act 1970Requires childproof packaging on all controlled and most Rx drugs dispensed by pharmacies, except if the prescriber or patient requests non-childproof.
Controlled Substance Act 1970Classifies 5 levels of drugs (controlled substances) that have potential for abuse and restricts their distribution; set up the Drug Enforcement Agency (DEA) to enforce regulations

Controlled Substance Schedules


Question Answer
Schedule Ihigh potential for abuse, no accepted use in US
Schedule IIhigh potential for abuse; accepted use (amphetamines, opiates, cocaine, etc)
Schedule IIImoderate potential for abuse; accepted use (anabolic steroids, limited quantities of narcotics such as codeine)
Schedule IVlow potential for abuse; accepted use (phenobarbitol, methohexital)
Schedule Vlow potential for abuse; accepted use (may contain small amounts of narcotics such as codeine)

DEA Forms

Question Answer
DEA Formsmust be filled out in pen/indelible ink and signed by an authorized person
Form 222order C-I and C-II substances
Form 41inventory of C-I and C-II drugs surrendered/returned
Form 106report theft/loss of C I and C II drugs
Forms 224, 224a, 224bRegistration/renewal/chain renewal
Forms 363,363aRegistration for Narcotic Treatment Program/renewal
Form 510for chemical registration

Classes of Recalls

Question Answer
Recall Class Istrong likelihood of serious adverse effects or death
Recall Class IImay cause temporary but reversible adverse effects; or little likelihood of serious adverse effects
Recall Class IIInot likely to cause adverse effects


Question Answer
American Society of Health-System Pharmacists (ASHP)for pharmacists practicing in hospitals, HMOs, long-term care facilities, etc. Accredits pharmacy residency and pharmacy tech training programs
United States Pharmacopeia (USP)sets standards for manufacture/distribution of drugs and related products in US; published standards in "USP and the National Formulary."
Joint Commission on Accreditation of Health Care Organizations (JCAHO)establishes standards/monitors compliance for healthcare programs (hospitals, HMOs, nursing homes, etc.)
American Society for Consultant Pharmacists (ASCP)sets standards of practice for pharmacists who provide medication distribution/consultant services to nursing homes

NDA and the IND

Question Answer
New Drugs safety requirement-FDARequired for all new drugs, domestic and imported
Two requirements before marketing in US1. Safe and effective; 2. benefits substantially outweigh risks
Pre-clinical testingTesting on cells or animals; before human testing
Clinical testingtesting on people
Phase I clinicalsmall group; short time; main purpose is safety
Phase II clinicalup to several hundred people; months to 2 years; short term safety, but main purpose is effectiveness
Phase III clinicallarge group; 1-4 years; purposes are safety, dosing and effectiveness
Amount of time spent testing, on average8.5 years
Single blind test (always this way at least)Patients don't know what treatment or placebo receiving
Double blind testNeither patients nor doctors know which treatment