MPJE Federal Flashcards

Timeline of Acts/Amendments

Pure Food & Drug Act of 1906

• prevent misbranded + adulterated drugs

Sherley Amendment (1912)

• expanded misbranded definition to cover therapeutic claims

• intent to defraud must be proven

  • loop hole - violaters can plead ignorance and escape enforcement

FD&CA of 1938 (follows sulfanilamide disaster 1937)

• File an NDA for “new drugs” to provide safety data (non toxic)

  • “new drugs” - before 1906 Act; not previously recognized as safe

  • “grandfathered” - subject to 1906 act & labeling unchanged yet still recognized as safe after clinical investigations

• adulteration (composition)

• misbranding (label)

• Covers medical devices & cosmetics

• “Grandfather clause”

Durham-Humphrey Amendment of 1951 (effective in 1952)

• Prescription (legend) vs Non-prescription (non-legend, OTC)

• used to have a dual coverage for levonorgestrel (Plan B)

  • Rx if < 18 yo; OTC 18+

  • removed age restrictions now and is completely OTC

Kefauver-Harris Amendments of 1962 (drug efficacy)

• Post thalidomide disaster —> created IND to conduct human clinical studies w/o NDA approval, after submitting preclinical (animal studies)

• report ADRs to FDA via FAERs

• FDA to review/evaluate 1938-1962 drugs for effectiveness by the DESI (Drug Efficacy Study Implementation) panel

  • ANDA if mfr only needed to make a labeling change

    • also approved generic versions

  • OTC drug categories made (another flashcard)

• must comply GMPs

• procedure for IND & NDA (informed consent, FAERs, review drug investigation qualifications)

• Rx ads (FDA); OTC ads (FTC)

Drug Price Competition & Patent Term Restoration Act of 1984

/Waxman Hatch

• eliminated paper NDA; only ANDA - applicable to all generics

• +5 years of patent protection (max effective patent life of 14 years)

  • later extended to 20 years from filing date

Poison Prevention Packaging Act of 1970

• require special packaging - childproof < 5 yo; so they cant open easily

  • with exceptions (ie. SL nitroglycerin, etc.) - p. 28 - 20

    • + hospitalized inpatients (bc administered by nurse)

    • + mfr stock bottles if rph repackages prior to dispensing

  • blanket authorization - waive act via writing per pt/pt’s family consent

    • rph must periodically check in & confirm if they want to continue preferred packaging choice

• Reversible/dual-purpose packaging discouraged

Medical Device Amendments of 1976

• required premarket approval of safety & effectiveness

• 3 classes of devices (another flashcard)

Federal Anti-Tampering Act

• Post Tylenol contamination in 1982

• tamper-evident packaging (not tamper-proof)

  • exemptions (another flashcard)

Orphan Drug Act of 1983

• 200,000 cut off for “orphan drug status” exclusive market x 7 years

Prescription Drug Marketing Act of 1987

• reduce public health risk

• reimportation - banned

• state licensure required

• drug samples

  • not to be sold

  • with limitations on drug sample distributions

    • only via mfr/distributor

    • written request by licensed practitioners

      • Pharmacists can never request sample

  • mfr to report discrepancies/suspected falsification of sample requests < 30 days to FDA

Anti-Drug Abuse Act of 1988 - 2 related to pharmacy

• those convicted of illegally distributing human growth hormone

  • 5 yr imprisonment +/- fine

    • minor: 10 yr imprisonment or fine

• sale of butyl nitrite + its isomers = banned

  • except for commercial purposes not resulting in misuse for euphoric effects

Onmibus Budger Reconciliation Act of 1990 (OBRA-90)

• enacted by congress to contain medicare costs & ensure proper medication utilization

  • prospective DUR (review medicare pt profile before filling)

  • must offer counseling to patient

    • extended to non-medicare recipients as well

  • proper maintainence of records

Dietary Supplement Health & Education Act of 1994

• not drug; subject to food laws

• burden on FDA to prove an unreasonable risk of illness/injury

• labeling req: not evaluated by FDA; not intended to dx/prevent/tx/cure, etc

FDA Modernization Act of 1997

• off-label uses

  • Eased strict prohibitions against pharmaceutical companies distributing information regarding off-label uses of FDA-approved drugs and devices

  • allowed manufacturers to provide physicians with peer-reviewed journal articles and scientific literature about unapproved uses, provided they committed to conducting further research

Combat Metamphetamine Epidemic Act of 2006

• pseudoephedrine decongestant (+ ephedrine & phenylpropanolamine) —> metamphetamine

• sale limits (another flashcard)

Biologics Price Competition & Innovation Act (BPCIA) 2009

Drug Quality & Security Act

• Title 1 - compounding (another flashcard)

  • 503A safe harbor (pt-specific rx

  • 503B (outsourcing facility)

• Title 2 - drug supply chain security act

  • track-and-trace electronic system

Federal Controlled Substances Act

Ryan Haight Online Pharmacy Consumer Protection Act of 2008

OTC Categories 1,2,3

ANDA - OTC drugs were examined by active ingredients and placed into 1/3 therapeutic categories:

• Category 1: GRAS/GRAE (generally regarded as safe/effective)

• Category 2: deemed unsafe, uneffective, or both

• Category 3: insufficient data to determine safety +/- efficacy

Violations of FD&CA penalties (2) + Recall Classifications (3)

violations of FD&CA (misbranded/adulterated)—>

• first offense: up to $1000 fine +/- 1 yr imprisonment

• second offense/intent to defraud or mislead:

  • up to $10,000 fine +/- 3 yrs imprisonment

recalled by mfr (voluntarily); not FDA (but can strongly suggest recall)

• Class I = serious adverse health consequences or death

• Class II = temporary or medically reversible adverse health consequences

• Class III: not likely to cause adverse health consequences

Medical Device - 3 Classes in assuring product safety & effectiveness

1976 Amendment - required premarket approval for safety/effectiveness

Class I (General controls) - safest

• scissors, forceps, needles, toothbrush, stethoscope

Class II (Special controls) - performance standards

• hearing aids, sun lamps, thermometers, catheters, in-home test kits, insulin syringes, electric heating pads

Class III (Premarket Approval) - most dangerous

• implanted & life-supporting or life-sustaining devices required to have FDA approval for safety & effectiveness before marketing

• contact lenses, pacemakers

Restricted devices - restricted to sale only upon a written/oral prescription of licensed practitioner to administer such device due to potential harm

• ie. aerochambers

Federal Anti-Tampering Act (1982) - exemptions to tamper-evident packaging (5)

(1) Dermatological products

(2) Lozenge products

(3) Prescriptions not accesible to the general public

(4) Insulin products

(5) Dentrifice products (toothpaste, dental floss, and dental adhesives)

NOT Exempt: Cosmetic liquid oral hygiene products (mouthwash/mouth freshners) & cosmetic vaginal products

Pregnancy information in the order presented in the prescribing information

• Pregnancy exposure registry

• Risk summary statements - based on data from relevant sources (in this order)

  • Human, animal, pharmacologic

• Cinical considerations - if available

• Data (that is the basis for risk summary)

National Drug Code (NDC) segments

first segment (4-6 digits) - labeler code/manufacturer

second segment (3-4 digits) - product code: strength/dosage form by mfr

third segment (1-2 digits) -package code; package size

OTC labels - electrolyte thresholds

Na+ terminology on label:

• Sodium free ( <= 5 mg)

• Very low sodium (<=35 mg)

• Low sodium (<= 140 mg)

• *include warning on label if Na > 140 mg

Label if electrolytes exceeds:

• 20 mg Ca2+ (3.2g)

• 8 mg Mg2+ (600 mg)

• 5 mg K+ (975 mg)

• (warning label in case of being on electrolyte-restricted diets)

DEA forms + other form #s

DEA 222

DEA 224

DEA 106

DEA 41

Form SMA - 163

Schedule C-I drugs (3-4)

• Heroin (Diacetyl morphine)

• Marijuana (legal in NJ tho)

• LSD (Lysergic acid diethylamide)

• Mescaline - controversy

Schedule C-II drugs (8)

• Opium

• Methadone

• Morphine

• Codeine

• Oxycodone

• Meperidine

• most amphetamines and many barbiturates

Schedule C-III drugs (4)

• Steroids

• Amphetamines

• Tylenol with Codeine

  • Not more than 1.8 g codeine per 100 mL or not more than 90 mg per dosage unit with one or more active non-narcotic ingredient

• Suboxone

Schedule C-IV drugs (3)

• Valium

• Phenobarbital

• Tramadol

Schedule C-V drugs

Antitussive preparations with codeine, etc.

“Exempt Narcotic” Record Book (OTC C-V)

• Sale restrictions (2)

• Codeine limit

• years retained

• paregoric vs opium tincture

Sale restrictions:

• Sale by RPh only

• Purchaser > 18 years old

Codeine limit:

• Other CS such as codeine, no > 4 oz. (120 cc) or 24 dosage units of any other nonprescription CS in any 48 hour period

Retained for 2 years (NJ - 5 years)

Paregoric tincture - aka Camphorated Tincture of Opium (0.4 mg morphine per mL) = C- III

Opium Tincture (10 mg morphine per mL) = C-II (more concentrated)

Pseudoephedrine Sale/Mail-Order Limits

includes pseudoephedrine, ephedrine, phenylpropanolamine:

• Sales limits: 3.6 grams of ephedrine, pseudoephedrine, or phenylpropanolamine per purchaser per day

  • up to 9 grams per purchaser per 30-day period (of which no more than 7.5 grams can be via mail or carrier)

• Mail order limits: 7.5 grams per customer per 30-day period