Lecture 8

Question 1

T/F: Drug monographs within the USP have the force of law

Answer 1

T

Question 2

Status of drug that does not follow the drug monograph

Answer 2

Adulterated or Misbranded

Question 3

T/F: USP-published information on the appropriate means for drug preparation and drug storage has the force of law federally

Answer 3

F

Question 4

Purpose of USP 795

Answer 4

Focuses on ensuring the quality and safety of nonsterile compounding and requires beyond-use dates to be assigned to nonsterile products

Question 5

Purpose of USP 797

Answer 5

Covers numerous sterile compounding requirements, including personnel, training, facilities, environmental monitoring, and storage and testing of finished products

Question 6

Purpose of USP 800

Answer 6

Discusses the handling of hazardous drugs in healthcare settings

Question 7

Drugs that constitute as hazardous

Answer 7

Carcinogenic, teratogenic or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or new drugs that mimic existing hazardous drugs

Question 8

Expiration date of a drug

Answer 8

Last date the product will meet the requirements of the USP monograph for the strength or stability

Question 9

Two ways of writing expiration dates

Answer 9

Exact date (January 21, 2029) or month and year (Jan 2029)

Question 10

Assumption of expiration date as month and year

Answer 10

Assume the product is good through the last day of the month noted

Question 11

Beyond use date (BUD)

Answer 11

Date after which a product should not be used; cannot be later than an expiration date and is often soone

Question 12

Factors that affect beyond use dates

Answer 12

When a product is opened, storage, reconstitution, and stability or sterility data

Question 13

T/F: A BUD should not be later than the expiration date on the manufacturer’s container or 1 year from the date the drug is dispensed, whenever is earlier

Answer 13

T

Question 14

Repackaging

Answer 14

When a location takes a drug from the manufacturer’s bottle and puts it into a new package without doing other things

Question 15

Provisions that repackaged products must meet

Answer 15

FDCA

Question 16

T/F: Taking a drug out of a stock bottle and placing into a prescription bottle for dispensing meets the criteria for repackaging

Answer 16

F

Question 17

Exemptions of FDCA repackaging requirements

Answer 17

1. Prescription drug product on the drug shortage list
2. Drug product repackaged under direct supervision of a licensed pharmacist
3. If repackaged by a pharmacy, only distributed upon receipt of a valid prescription for an individual patient
4. Repackaged product is assigned a BUD as described in the repackaging guidance

Question 18

BUD for repackaged FDA-approved product with specific in-use time

Answer 18

BUD established with in-use time or expiration date on the product repackaged, whichever is sooner

Question 19

BUD for repackaged non-aqueous formulation of FDA-approved product without an in-use time

Answer 19

No more than six months or the expiration date, whichever is sooner

Question 20

BUD for repackaged water-containing oral formulation of FDA-approved product without an in-use time

Answer 20

No more than 14 days or the expiration date, whichever is sooner

Question 21

BUD for repackaged water-containing topical, mucosal, and semisolid formulation of FDA-approved product without an in-use time

Answer 21

No more than 30 days or the product expiration date, whichever is sooner

Question 22

BUD for repackaged FDA-approved sterile product with specified in-use time

Answer 22

BUD established with in-use time or the expiration date on the product repackaged, whichever is sooner

Question 23

BUD for repackaged FDA-approved sterile product without a specified in-use time or unapproved product

Answer 23

BUD established by USP 797 or the expiration date of the product repackaged, whichever is sooner

Question 24

Types of pharmacy inspections

Answer 24

Routine inspection (done periodically at random) or an inspection triggered by knowledge, suspicion, or a formal complaint of wrongdoing that may be a danger to public safety

Question 25

Who conducts inspections

Answer 25

FDA, DEA, and State Board of Pharmacy

Question 26

Why would the FDA inspect a pharmacy

Answer 26

May inspect a pharmacy to determine if they manufacture drugs and to verify compounding is done appropriately

Question 27

How can FDA inspectors request entry to a pharmacy

Answer 27

By showing a notice of inspection (FDA form 482) and their credentials

Question 28

DEA inspections

Answer 28

Examine records and reports related to controlled substances, inspect the premises, and inventory conrolled substances without a warrant

Question 29

Requirements for DEA inspector when requesting inspection

Answer 29

State the purpose of their inspection, show their credentials, and provide written notice of inspection to the pharmacy ownder or pharmacy in charge

Question 30

Following rights included in the DEA Notice of Inspection (NOI)

Answer 30

1. You have the right to require the DEA to get an administrative inspection warrant (AIW) 2. You have the right to refuse an inspection (at which point they will give you an AIW) 3. Anything incriminating found can be seized and used against you in prosecution 4. You will get a copy of the NOI 5. You may withdrawal your consent to inspection at any time

Question 31

Two types of warrants utilized by the DEA

Answer 31

Administrative inspection warrants (AIW) and search warrants

Question 32

Purpose of administrative inspection warrants (AIWs)

Answer 32

Provided for anything considered a valid public interest; low bar to clear

Question 33

Purpose of search warrant

Answer 33

Provided if an officer can convince a judge that a reasonable person would believe that a crime has been or will be committed on the premises to be searched or that evidence relevant to a crime exists at the premises; high bar to clear

Question 34

When can AIWs be served?

Answer 34

Regular business hours

Question 35

When can search warrants be served?

Answer 35

Anytime

Question 36

Can you say no to Board of Pharmacy inspections?

Answer 36

No

Question 37

Can BoP inspectors inspect without a warrant?

Answer 37

Yes

Question 38

What provides equivalency ratings for many products

Answer 38

Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)

Question 39

What provides interchangeable biological product information?

Answer 39

The Purple Book (Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations)

Question 40

Reference listed drug (RLD) in the Orange Book

Answer 40

Original brand name product

Question 41

Reference standard (RS)

Answer 41

Product to which the generic must demonstrate equivalency

Question 42

Therapeutic equivalence

Answer 42

Pharmaceutical equivalence + bioequivalence

Question 43

Pharmaceutical equivalence

Answer 43

Same active ingredient, dosage form, strength, route, and labeling

Question 44

Bio-equivalence

Answer 44

Same in vivo (human) results and in vitro (lab) results

Question 45

Therapeutic equivalence (TE) code

Answer 45

First letter indicates the relevant therapeutic equivalence code (if substitutable or not) and second letter indicates the dosage form (T= topical, X= insufficient data)

Question 46

Therapeutic equivalence of drugs with a three-character code

Answer 46

Considered therapeutically equivalent only to other drugs with the same three-character code (AB1 = AB1; AB1 ≠ AB2)

Question 47

Therapeutic equivalence code A_

Answer 47

Product is therapeutically equivalent, with no concerns related to pharmaceutical equivalence or bioequivalence

Question 48

Therapeutic equivalence code B_

Answer 48

Product is not therapeutically equivalent, with concerns related to pharmaceutical equivalence and/or bioequivalence