Law Exam 1

• USP standards for prescription labels

  NOTE - enforcement based on state

  Requires:

  1. patient's name

  2. prescription #

  3. generic and brand name

  4. strength

  5. directions
• NYS file storage of prescriptions

  1. filled and dispensed prescription is legally owned by the pharmacy

  2. DO NOT remove from file unless court order

  3. maintained for 10 years in paper or electronic form
• when is a pharmacist allowed to refuse a prescription fill

  1. suspected forgery

  2. suspected violation of law

  3. drug not in stock

  4. may be harmful to patient
• vaccines for children program (VFC)

  federally funded that provides vaccines to children who would otherwise be unable to afford it
• Drug approval process

  1. preclinical studies/data

  2. investigational new drug application (IND)

  3. Phase 1 - healthy subjects and assess SAFETY

  4. Phase 2 - disease subjects and assess safety, efficacy, dosage form, side effects

  5. Phase 3 - mass testing and assess efficacy compared to placebos

  6. New Drug Application (NDA)

  7. Phase 4 - post marketing surveillance
• inflation reduction act of 2022

  Requires:

  1. federal gov to negotiate prices for drugs covered in Medicare B/D starting 2026

  2. manufacturers pay rebates to Medicare if prices rise faster than inflation

  3. cap out-of-pocket expenses for Medicare D beneficiaries

  4. cap monthly cost of insulin to $35 for Medicare beneficiaries

  5. remove cost-sharing for adult vaccines for Medicare D

  6. establish low-income subsidy program

  7. delays implementation of Trump's rebate rule to 2027
• Affordable Care Act (aka Health Care Reform Act/Obama Care) of 2010

  Requires:

  1. all individuals have health insurance

  2. standardizes financial and administrative transactions

  3. prohibits third-party agreements to limit/delay generic drugs

  4. attempt to eliminate "donut hole"
• FDA Modernization Act of 1997


  States:

  1. expedited approval of new drugs for serious conditions

  2. individual states regulate compounding

  3. pharmacies exempt from GMP standards

  4. changed "Caution: Federal law prohibits dispensing w/o prescription" >>>>> "Rx only"

  5. removed warning labels of habit-forming drugs

  6. encouraged research of new/unapproved uses for drugs

  7. established drug approval process (PUT PICTURE OF THIS)
• Prescription Drug Marketing Act of 1987

  Prevented:

  1. reselling pharmaceuticals to other businesses

  2. pharmacies distributing drug samples
• Drug Price Competition and Patent Term Restoration Act of 1984 (aka Waxman-Hatch Amendment)

  Amended:

  1. dispute b/t generic and brand manufacturers

  2. streamlined drug approval process for generics

  3. provided incentives to develop new drugs
• Orphan Drug Act of 1983

  Provided incentives for the development of orphan drugs for treatment of rare diseases
• Medical Device Amendment of 1976

  Required:

  1. classification according to function

  2. established performance standards

  3. pre-market approval requirements

  4. conform to GMP standards

  5. established record/reporting requirements
• WHY was Kefauver-Harris Amendment of 1962 (aka Drug Efficacy Amendment)

  public concern about birth defects from thalidomide
• Kefauver-Harris Amendment of 1962 (aka Drug Efficacy Amendment)

  Required:

  1. safe and effective

  2. regulation of drug advertisements via FDA

  3. informed consent by research subjects

  4. reporting of side effects

  5. Good manufacturing practices (GMP) - no contaminants during drug manufacture
• Durham-Humphrey Amendment of 1951

  Required:

  1. division of drugs into OTC and prescription

  2. medical supervision for prescription only

  3. "Caution: Federal law prohibits dispensing w/o prescription" on label

  4. OTC drug label directions for use
• flaws of Food, Drug, and Cosmetic Act of 1938

  drugs already on the market prior to this law were "grandfathered" - allowed to remain without regulatory approval

  example: levothyroxine
• Food, Drug, and Cosmetic Act of 1938

  Required drug products:

  1. proven safe

  2. label directions for use

  3. warnings about habit-forming drugs

  4. 1st law to apply to cosmetics and medical devices
• flaws of Pure Food and Drug Act of 1906

  Did NOT:

  1. require list of ingredients

  2. label directions for use

  3. regulate cosmetics and medical devices

  4. need to be safe
• WHY was Pure Food and Drug Act of 1906

  107 deaths from liquid sulfanilamide
• Pure Food and Drug Act of 1906

  prohibit adulterated or misbranded food/drugs for distribution
• what is the mission of the United States Pharmacopoeia (USP)

  1. standards of quality

  2. authoritative information
• what does the state gov regulate?

  1. compounding

  2. defines personnel

  3. defines conditions for storage and distribution on individual basis
• What does the federal gov regulate?

  1. manufacturing process

  2. distribution/importation

  3. use of pharmaceuticals
• what is NOT required on a prescription label according to federal law?

  Expiration date and lot number
• Poison prevention packaging act (PPPA)

  1. special packaging features to prevent access to children under 5 years old
  2. glass containers = reusable
  3. plastic containers = replaced
• federal anti-tampering act of 1982

  packaging features with an indicator or barrier that tampering was evident for select OTC and cosmetics (especially if oral)
• patient package inserts (PPIs)

  written in lay language about proper use and dangers of a drug. MUST be provided in Accutane, "statin" drugs (HMG-CoA reductase inhibitors), estrogen/progesterone drugs
• repackaging guidelines

  expiration date should NOT exceed 25% of the time between day it was dispensed and manufacturer expiration OR 6 months from day it was dispensed; whichever of the two is LEAST

  1. repackaged 2/1/24 + manufacturer 9/30/24 = expiration 3/30/24 (2 mo)
  2. repacked 2/1/24 + manufacturer 12/30/25 = expiration 7/21/24 (5 mo + 3 wk)
• drug quality and security act of 2013

  all trading partners must have tracing systems of prescription products
• When can a pharmacy compound medications?

  1. quantity is reasonable
  2. anticipation based on prescribing habits and prescriptions already on file
  3. shortage of commercially available products. does NOT need prescription
• 503A compounding facilities

  traditional pharmacies that REQUIRE prescriptions to compound. can NOT compound STERILE products
• 503B compounding facilities

  voluntarily registered with FDA so must follow GMP standards and inspections. allows compounding of NONSTERILE and STERILE drugs. does NOT require prescriptions
• National drug code (NDC)?

  1. Manufacturer code
  2. ID of drug
  3. ID of package
• Adulterated vs misbranded

  Adulterated = contains filth, unapproved color additive, manufactured not under GMP standards

  misbranded = false labeling
• A rated generic products

  1. Bioequivalent AND therapeutically equivalent
  2. can substitute other A rated products
• B rated generic products

  1. NOT bioequivalent
  2. CANNOT be susbstituted with other B rated products
• adverse drug experience/adverse drug reaction

  ADE or ADR
• abbreviated new drug application

  ANDA
• alcohol, tobacco, firearms agency

  ATF
• complementary and alternative medicine

  CAM