Reading 3

Question 1

What is Adulteration in pharmacy law?

Answer 1

• Issues inside or with the product

the FDA wants to prevent this from happening

Question 2

What are the eight statements that say when a drug is adultered by law?

Answer 2

• Bad Products (Filthy, Putrid, Decomposed)
• Bad Conditions (Prepared, Packed, or held under Insanitary Conditions)
• NOT using CGMP
• Bad Containers (deleterious substances)
• Bad Coloring Agents
• DOES NOT meet offical standards
• Mixing to reduce quailty
  -Refuse Inspections

CGMP = Current Good Manufacture Processes

Question 3

What does the FDA do in terms of Adultertion?

Like when do they check?

Answer 3

• Can really check the during and after of manufacturing but they try to prevent it from happening

Question 4

What are Current Good Manufacturing Practices?

Answer 4

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

Question 5

What is Misbranded in Pharmacy Law?

Answer 5

• Issues outside of the product OR the words that are associated with the product

Question 6

What are the 12 concepts that related to misbranding for pharmacy law

Answer 6

• False or Misleading Labels
• NO Manufacturer Info
• NO Quantity Info
• Info NOT displayed properly
• NO name on label
• NO directions or warnings on label
• NOT packaged properly
• NOT labeled for deterioration
• Color agent NOT listed
• Name NOT on Ads
• Violates PPPA
• REMS not followed

Caution with how you tell patients to take OTC drugs

Question 7

What is compounding?

Answer 7

• Combining two or more drugs to make one
• Since NOT manufacutred then NO FDA approval

Question 8

What are the 2 types of compounding?

Answer 8

• Pharmacy or Traditional (503A)
• Outsourcing Facilities (503B)

Question 9

What is 503A compounding?

Answer 9

• Creating small batches for specific patient (NO Manufacturing)
• EXEMPT from cGMP, some misbranding, and new drug requirements

Question 10

To be exempt, what are some of the general requirements?

What are the exemptions again

Answer 10

• Issued to ONE patient…
• …based off of physicians judgement…
• …made by a pharmacist or physician

CGMP, Misbranding, New Drug Applications

Question 11

What are the exemptions for 503A compounding

Answer 11

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

Question 12

What are 503B compounding pharmacies?

Answer 12

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

These have to follow CGMP and met specific labing requirements

Question 13

What are some of the labeling requirements for a 503B compounded drug?

11

Answer 13

• Saying “Compounded Drug”
• Name, Address, Phone # of facility
• Lot & Batch #
• Generic Name
• Dosage & Strength
• Quantity & Volume
• Exp or BUD
• Storage requirements
• NDA, if available
• Saying “NOT for Resale”
• List of ingredents (both active and not)

Question 14

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

Answer 14

• Class I, II, III
• New devices marketed after 1976

Question 15

What is a class I device?

Answer 15

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

Question 16

What is a class II device?

Answer 16

• 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

Question 17

What is a class III device?

Answer 17

• 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

Question 18

What are restricted devices?

Answer 18

• REQUIRE a presricption to use
• REQUIRE training

Question 19

What are Custom Devices?

Answer 19

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

Question 20

What items are voluntary recalls and what are mandatory recells?

Answer 20

• Drugs = Voluntary
• Devices = Mandatory

Question 21

What are the different classes of Recall?

Answer 21

• Class I, II, III

Question 22

What are class Irecalls?

Answer 22

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

Question 23

What are class II recalls?

Answer 23

• Sitations where taken may cause adverse events may occur

Question 24

What are class III recalls?

Answer 24

• exposure wont really cause any adverse effects

Question 25

What id the process when a drug is recalled>

Answer 25

- Depends on the severity but it will be the **manufacturer** notifiying the **pharmacist (retail)** then they notify the **patient**

Question 26

# Practice Question 1 Products compounded by pharmacies are not held to the same requirements for cGMP, misbranding, and new drug approvel as marketed products? ## Footnote a. True b. False

Answer 26

- a. True

Question 27

# Practice Question 2 A manufacturer recentyl recalled a specific lot of prescription of birth control that had the pills in reverse order. Which type of recall has most likely been issued? ## Footnote a. Class I b. Class II c. Class III d. Class IV e. They're unlikely to issue a specific type of recall

Answer 27

- b. Class II

Question 28

# Practice Question 3 All of the following situations would be considered adulteration EXCEPT: (Select all that apply) ## Footnote a. A pharmacy repackages a drug and forgets to place an expiration date on the label b. A company follows cGMP when manufacturing c. A drug product doesn't conform to compendial standards but is labeled "not USP" d. A drug product has a lower strngth then what the label says e. A drug product in a container that is radioactive

Answer 28

- B, C

Question 29

# Practice Question 4 Which of the following situations would be considered misbrading? (Select all that apply) ## Footnote a. An oral controlled substance is not dispensed in child-resistant packaging b. A brand name drug list the generic on the label c. A drug product can develop a precipitate, and there are warnings included in the package insert d. A prescription drug is dispensed without a prescription e. A drug product is manfactured with an unsafe color agent

Answer 29

- A, D

Question 30

# Practice Question 5 A Class I device is the complicated device type and requires premarket approval ## Footnote a. True b. False

Answer 30

- b. False