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PHRM 871: Law > Reading 3 > Flashcards

Reading 3 Flashcards

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1
Q

What is Adulteration in pharmacy law?

A
  • Basically issues that when a substance is mixed or packaged alters the quailty or strength
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2
Q

What are the Eight main summarys that define “Adulteration”?

A
  • Filthy, Putrid, Decomposed [expired or contaminated]
  • Using insanitary conditions [bad temps, environement]
  • NOT using good manufacturing processes
  • Container is not good material
  • Unsafe Coloring agents
  • DOES NOT meet offical standards
  • Mixed to reduce quaility
  • NO Inspections
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3
Q

What does the FDA do in terms of Adultertion?

Like when do they check?

A
  • Cant really check processes BUT…
  • Can check facilities, warehouses, containers, testing logs
  • Focus on Prevention of adulteration rather than removing the products
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4
Q

What are Current Good Manufacturing Practices?

A
  • Regulations that establish minimum requirements for making drug products for human/animals to use
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5
Q

What is Misbranded in Pharmacy Law?

A
  • Issues that are dealing with the label and labeling of the product
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6
Q

What are some of the concepts that defines Misbranding?

A
  • False or Misleading Labels
  • Manufacturer/Quaility info missing
  • Information on prominently displayed
  • NO Established Names
  • Wrong directions/warnings
  • Packaging violates PPPA
  • REMS not followed…
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7
Q

What is compounding?

A
  • Combining two or more drugs to make one
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8
Q

What are the 2 types of compounding?

A
  • Pharmacy Compounding
  • Bulk Compounding [Outsourcing Facilities]
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9
Q

What does it mean when its “Pharmacy or Traditional Compounding” (503A)?

A
  • Creating small batches for specific patinets
  • EXEMPT from cGMP, some misbranding, and new drug requirements
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10
Q

What are the three elements that a compound made through Pharmacy or Traditional methods must me to be real?

A
  • MUST be for ONE patient
  • Based off of Physician judgement
  • Made by Pharmacist
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11
Q

What are compounds that are made from Traditional (503A) Facilities exempt from?

A
  • cGMP; because they are making a single batch NOT bulk
  • Some Misbranding; must follow labeling and NOT manufacturer
  • New Drug Requirements; they arent studied
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12
Q

How are Outsourcing Facilities (503B) define as?

A
  • Pharmacies or non-pharmacies that compound without prescriptions or orders
  • “the compounding, admixing, mixing, diluting pooling, reconstituting, or just altering a drug”
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13
Q

What are some of the requirements that have to be on a 503B compounded drug?

A
  • Saying “This is compounded”
  • Name, Address, Phone
  • Lot number and Batch
  • Dosage and Strength
  • Experation or BUD
  • Handling
  • ETC…
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14
Q

What are the classes of devices and when did they become classified?

A
  • Class I, II, III
  • New devices marketed after 1976
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15
Q

What is a class I device?

A
  • NOT used for supporting or sustaining life & NOT risk illness or injury
  • Low to Mod risk devices
  • i.e.: Stethoscopes, Scissors, Elastic Bandages, Tootbrushes
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16
Q

What is a class II device?

A
  • Mod to High risk devices that have special controls to ensure safety and effectiveness
  • i.e.: Syringes, Tampons, Condoms, pregnancy tests, wheelchairs…

43% of medical devices are this

17
Q

What is a class III device?

A
  • High risk device that Requires premarket approval
  • These ARE supporting life & ARE possible risks
  • i.e.: Pacemakers, heart values, breast implants, contacts
  • ALL devices are III unless the FDA says so
18
Q

What are restricted devices?

A
  • REQUIRE a presricption to use
  • REQUIRE training
19
Q

What are Custom Devices?

A
  • Devices that are personalized to fit the needs of a patients
20
Q

What items are voluntary recalls and what are mandatory recells?

A
  • Drugs = Voluntary
  • Devices = Mandatory
21
Q

What are the different classes of Recall?

A
  • Class I, II, III
22
Q

What are class I recalls?

A
  • MOST SERIOUS; theres a probability that if used will kill
23
Q

What are class II recalls?

A
  • Sitations where taken may cause adverse events may occur
24
Q

What are class III recalls?

A
  • exposure wont really cause any adverse effects

PHRM 871: Law (19 decks)

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