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texas mpje > Ch 1: Federal Laws > Flashcards

Ch 1: Federal Laws Flashcards

1
Q

Food, Drug, and Cosmetic Act

A
  • FDCA, 1938
  • Followed deaths caused by sulfanilamide elixir in 1937
  • Congress passed requirement that new drugs are proven SAFE to marketing
  • Established FDA
  • Primary federal law dealing with food, drug, cosmetic, and medical device safety today
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2
Q

Durham-Humphrey Amendments

A
  • 1951
  • Established two drug classes: Rx and OTC
  • *Know which products are offered in each group**
  • Authorized VERBAL prescriptions and refills
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3
Q

Kefauver-Harris Amendments

A
  • 1962
  • Required drugs to be proven safe AND EFFECTIVE for their use
  • Increased safety requirements and established good manufacturing practices (GMP)
  • Gave FDA jurisdiction over Rx drug advertising
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4
Q

PDMA

A
  • Prescription Drug Marketing Act
  • 1987
  • Bans reimportation of Rx drugs/insulin produced in US EXCEPT by manufacturer
  • Bans sale/trade/purchase of Rx drug samples
  • Mandates storage/handling/recordkeeping for Rx drug samples
  • Prohibits resale of Rx drugs by hospitals/HC facilities (generally lower prices compared to community)
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5
Q

DQSA

A
  • Drug Quality and Security Act
  • 2013
  • Own card set due to extensive information
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6
Q

Prohibited Acts under FDCA

A
  • Nearly all of the acts cause the drug to be adulterated or misbranded
  • More commonly violated by manufacturers but pharmacists act can also cause it
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7
Q

Adulteration (9)

A
  1. Contains filthy, putrid, or decomposed substance
  2. Prepared/held under unsanitary conditions where it may be contaminated
  3. Methods used to manufacture don’t follow cGMPs
  4. Manufactured/processed/packed/held in any place where the owner or agents of the factory denies/delay/limit inspections or refuses permit to entry for inspection
  5. Container composed of poisonous/deleterious substance which could contaminate drug
  6. Unsafe color additive
  7. Purports to be official compendium drug but its strength/purity differs/falls below standards UNLESS difference clearly stated on label
  8. Not in compendium and its strength or quality falls below what is labeled (represents)
  9. Mixed/packed with any substance that reduces strength/quality OR drug has been substituted in whole/part
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8
Q

Misbranded (8)

A
  1. Label is false/misleading in any way
  2. Prescription drug/manufacturer labels fails to contain required information
  3. OTC drug that fails to include required information
  4. Drug is liable to deterioration unless packaged/labeled accordingly
  5. Container is made/formed/filled to be misleading
  6. Drug has exact information of another drug or sold under another drugs name
  7. Dangerous to health when used in manner/dosage suggested on label
  8. Packaged/labels in violation of Poison Prevention Packaging Act
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9
Q

Required Rx Drug Info (10)

A
  1. Name/address of manufacturer, packager, or distributor
  2. Brand/generic name
  3. Net quantity
  4. Weight of active ingredient per dose
  5. “Rx only”
  6. Specify route of administration if not oral
  7. Special storage instructions PRN
  8. Manufacturer control number (lot)
  9. Expiration date
  10. Adequate INFORMATION for use (PI) - including box warning, more for HC providers
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10
Q

Required OTC Info

A
  1. Principle display panel, including statement of identity of the product
  2. Name/address of manufacturer, packager, or distributor
  3. Net quantity of contents
  4. Caution/warnings needed to protect user
  5. Adequate DIRECTIONS for safe/effective use - layperson
  6. Content/format of OTC products labeling in “Drug Facts” panel
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11
Q

Required Contents of Drug Facts Panel

A
  1. Active ingredients
  2. Purpose
  3. Use(s) - indications
  4. Warnings
  5. Directions
  6. Other Information
  7. Inactive ingredients (alphabetical)
  8. Questions? Telephone number (optional)
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12
Q

Adulteration/Manufacturing Applied to Pharmacists (10)

A
  1. Dispensing prescription w/o authorization makes it misbranded even if labeled correctly (only exempt from Rx labeling products when dispensed pursuant to a valid script)
  2. Misfiling a script with wrong drug/strength/directions for use = misbranded
  3. If misfilled script also involves wrong STRENGTH, it would be adulterated (strength differs from what it represents)
  4. REMS drug and dispensed without meeting REMS requirements = misbranded
  5. Advertising/promotion compounded drug that is false/misleading = misbranded
  6. Expired drug product in manufacturer bottle = adulterated (strength can’t be assured); misbranded if Rx filled with expired product and BUD is after expiration date of drug
  7. Pharmacist counts medication on tray that has residue of other medication = adulterated
  8. Stores inventory in room/refrigerator where temp isn’t adequately controlled = adulterated
  9. Store specific product product incorrectly (shelf vs fridge) = adulterated
  10. Fail to dispense child-resistant container when needed = misbranded
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13
Q

FD&C Yellow No. 5 and No 6 OTC Label Requirements (per FDCA)

A

Must be disclosed and provide warning in “precautions” label for allergic reaction risk

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14
Q

Tartrazine

A

FD&C Yellow No. 5

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15
Q

Aspartame OTC Label Requirements (per FDCA)

A

Must have “precaution” warning for PKU patients (contains phenylalanine __ mg per __ dosage unit)

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16
Q

Sulfites OTC Label Requirements (per FDCA)

A

Rx drug contains sulfites (preservative) and must have allergy warning in “warning” section

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17
Q

Mineral Oil OTC Label Requirements (per FDCA)

A
  • Warning to be taken at bedtime and not used in infants unless recommended by provider
  • Cannot encourage use in preggo
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18
Q

Wintergreen Oil OTC Label Requirements (per FDCA)

A
  • AKA Methyl salicylate
  • Containing >5% methyl salicylate must include warning that use other than directed may be dangerous
  • Article should be kept out of reach of children
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19
Q

Sodium Phosphates OTC Label Requirements (per FDCA)

A
  • Limits amount of sodium phosphates oral soln to no more than 90 mL per OTC container
  • Specific warnings required
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20
Q

Isoproterenol Inhalation Preparations OTC Label Requirements (per FDCA)

A
  • Requires warning not to exceed dose prescribed

- Contact physician if experiencing difficulty in breathing

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21
Q

Potassium Salt Preps for Oral Ingestions OTC Label Requirements (per FDCA)

A
  • Requires warning regarding nonspecific small bowel lesions consisting of stenosis, w/ or w/o ulceration
  • Associated with administration of EC thiazides coated with potassium salts
22
Q

Ipecac Syrup OTC Label Requirements (per FDCA)

A
  • Boxed/Red letters: “For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room immediately for advice”
  • Warning: “Warning: Keep out of reach of children. Do not use in unconscious persons”
  • Dosage of medication MUST appear (usually 1 tablespoon/15 mL in people >1 yo)
  • May be sold in 1 oz (30 mL) containers
23
Q

Phenacetin OTC Label Requirements (per FDCA)

A
  • Acetophenetidin

- MUST contain warning about potential kidney damage when taken in large amount or over long periods of time

24
Q

Salicylates OTC Label Requirements (per FDCA)

A
  • ASA and other salicylates must have special warning about Reye’s syndrome when used in kids
  • Retail containers of 1.25 grains (pediatric) ASA cannot be sold in containers holding more than 36 tablets
25
Q

Drugs for Minor Sore Throats OTC Label Requirements (per FDCA)

A
  • Any OTC product that states “for temporary relief of minor sore throats” MUST including warning
  • Warning: “Severe or persistent sore throat or sore throat accompanied by fever, HA, nausea, and vomiting may be serious. Contact physician promptly. Do not use more than 2 days or administer to kids under 3 yo unless directed by physician.”
26
Q

Alcohol OTC Label Requirements (per FDCA)

A
  • Internal analgesics and antipyretics including APAP, ASA, Ibu, naproxen, and ketoprofen
  • Required warning: Persons consuming 3+ alcoholic beverages per day to consult with doctor before taking
27
Q

Vaginal Contraceptive/Spermicide OTC Label Requirements (per FDCA)

A
  • Containing nonoxynol-9
  • Subject to several warnings
  • “STDs alert: This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from infected partner”
28
Q

Pain Relievers OTC Label Requirements (per FDCA)

A
  • APAP: must have acetaminophen prominently displayed, warn about liver toxicity, not use other products containing APAP and talk to doctor/pharmacist before taking warfarin
  • NSAIDs: Must have both NSAIDs/spelled out on bottle, must contain “stomach bleeding” warning
29
Q

Iron in Solid Oral Form OTC Label Requirements (per FDCA)

A

-Warning: “Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 yo. Keep out of reach of children. Call doctor or poison control center immediately in cause of accidental overdose”

30
Q

Tamper-Evident Packaging

A
  • OTC drugs for retail must package products in tamper evident packaging
  • If not packed properly would be considered misbranded and adulterated
  • Exceptions: dermatological, dentifrice, insulin, or lozenges
31
Q

Repackaging of OTCs

A
  • Repackaging of OTC is subject to cGMP requirements
  • Need to meet all additional requirements including manufacturer labeling and tamper-evident packaging if offered to sale to public
32
Q

OTC Prescribed/Filled Requirements

A
  • OTC labeling requirements do not have to be followed
  • Prescription drug labeling requirements would apply and include prescriber’s directions for use
  • Any instructions for refills would apply and BUD (1 year)
33
Q

FDA Recall Classifications

A
  • Class I: Reasonable probability product will cause serious AE or death
  • Class II: May cause temporary or medically reversible AE or where probability to serious AE is remote
  • Class III: Not likely to cause serious health consequences
34
Q

Advertising/Promoting Prescription Drugs

A
  • Prescription drug advertising is regulated by FDA
  • OTC drug advertising is regulated by FTC
  • Pharmacies that compounds may advertise compounding services, BUT if make any therapeutic claims of those products would be subject to FDA rules on advertising
35
Q

Advertising of Prescription Drug Prices

A
  • Considered reminder advertising by FDA
  • Exempt from FDA advertising regulations IF:
    1. Only purpose of advertising is to provide information on price (not safety/indication/efficacy)
    2. Contains proprietary name of drug, generic, strength, dosage form, and price charged for specific quantity of drug
    3. MAY include availability of professional or other types of services, IF not misleading
    4. Price stated on advertising shall include all changes to consumer (delivery/mailing fees, must be stated separately)
36
Q

PPIs

A
  • Supplied by manufacturer, written for layperson
  • Required to give to patients in community when new/refills of certain products are dispensed
  • Required for: oral contraceptives and estrogen-containing products
37
Q

Hospitalized Patients + PPI

A
  • Must be provided to patients prior to first administration of drug and Q30d after
  • Failure to provide would be considered misbranded
38
Q

Medication Guides

A
  • AKA MedGuides, similar to PPI program but with amended requirements for institutionalized patients
  • Written in standard format and suitable language
  • Obtain FDA approval and provide sufficient amount of MedGuides to pharmacies
  • Required for certain drugs (see flashcard)
  • FDA requires MedGuides for all new/refill scripts dispensed in the community setting when:
    1. Labeling could prevent serious AE
    2. Product has serious risks relative to benefits
    3. Patient adherence is crucial
39
Q

Drugs that Require MedGuides

A
  1. Accutane (isotretinoin)
  2. Antidepressants (kids/teens)
  3. Coumadin
  4. Epogen
  5. Forteo (teriparatide, rDNA origin)
  6. Lindane shampoo/lotion
  7. Lotronex (alosetron)
  8. Nolvadex (tamoxifen)
  9. NSAIDs
  10. Remicade
  11. Trizivar (Zidovudine/Aba/Lamiv)
  12. Opioids and cough products
  13. Benzos
    * *Failure to provide MedGuide makes these drugs misbranded**
40
Q

Rx Drugs: SE Statement

A
  • Enable consumers to report SE of Rx drugs to FDA => provide SE statement to pts when dispensing all new/refills to outpatient
  • SE Statement MUST including “Call your doctor for medical advice about SE. You may report SE to FDA at 1-800-FDA-1088”
  • Can be a sticker, preprinted on vial cap, separate sheet of paper, or found within CMI/MedGuides
41
Q

REMS

A
  • Strategies to manage known/potentially serious risks associated with drugs/drug class/biologics
  • Required if FDA finds necessary to ensure benefits outweigh risks of product
  • CAN include MedGuide, PPI, communication plan, elements to ensure safe use, and implementation system
  • MUST include timetable for assessment of REMS
  • Full list of required drugs on FDA website (can be drug class too)
42
Q

REMS Elements to Ensure Safe Use

A
  1. Special training, experience, certification of practitioners prescribing
  2. Special certification for pharmacies/practitioners/facilities dispensing it
  3. Dispensing drugs to patient only in certain HC settings
  4. Dispensing to patient with evidence /documentation of safe use conditions (labs)
  5. Monitoring patients using drugs
  6. Enrolling each patient using drug in registry
43
Q

NDC Number

A
  • Not technically required on drug’s label
  • Most manufacturers include since they facilitate automated processing of drug by govt agencies, third-party payers, wholesalers, and other manufacturers
  • NDC code does NOT indicate drug is approved by FDA
  • FDA proposed a standardized 11-number format, not approved yet
44
Q

Orange Book

A
  • “Approved Drug Products with Therapeutic Equivalence Evaluations”
  • On FDA’s website
  • Primary source for determining generic equivalency (pharmaceutically and therapeutically equivalent)
45
Q

Pharmaceutically Equivalent

A

Drug products with identical dosage forms and routes of administration that contain identical amounts of identical active drugs

46
Q

Therapeutically Equivalent

A
  • Drug products are pharmaceutical equivalents for which bioequivalence has been established
  • Same clinical effect and safety profile when administered to patients under the conditions specified in labeling
47
Q

Orange Book Lettering System

A
  • A: Drug products that FDA considered pharmaceutically/therapeutically equivalent
  • B: Drug products FDA does NOT consider pharmaceutically/therapeutically equivalent
48
Q

Orange Book Lettering, No Known Bioequivalence Issues

A
  • AA: conventional dosage forms
  • AN: solns/powders for aerosolization
  • AO: inj oil solns
  • AP: inj aq solns
  • AT: topical products
  • AB: actual/potential bioequivalence problems but sufficient evidence established bioequivalence
  • If multiple drugs are considered bioequivalent to referred drug product but NOT one another => AB1, AB2, etc.
49
Q

Purple Book

A
  • “List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluation”
  • List of drugs considered biosimilars w/ interchangeability evaluations done for products
  • Biosimilar = highly similar to reference product notwithstanding minor differences in inactive components; no clinically meaningful differences between biological product/reference in terms of safety, purity, and potency
  • Only those designated as “interchangeable” can be switched by pharmacist, OTHERWISE need physician intervention to sub
  • ONLY drug with interchangeable status currently is Semglee to Lantus (reference)
50
Q

Medical Devices

A
  • FDA regulates companies that manufacture/repackage medical devices
  • Devices do NOT achieve purpose through chemical action within/on body and do NOT depend on being metabolized
  • Classified based on risk of association with device
  • Not all require prescription, but many do
  • Certain Class I/II devices are exempt from premarket approval and GMPs, but must still comply with other regulatory requirements
51
Q

Medical Device Classes

A
  • Class I: Deemed low risk, therefore subject to less regulatory controls (Ex: dental floss)
  • Class II: Higher risk, require greater regulatory control (Ex: syringes)
  • Class III: Highest risk, highest level of regulatory control, require premarket approval by FDA due to significant risk of illness/injury (Ex: heart valve)

texas mpje (11 decks)

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