Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Pharmacy Law > Federal Law: Dispensing > Flashcards

Federal Law: Dispensing Flashcards

You may prefer our related Brainscape-certified flashcards:
Civil Procedure 1L flashcards MBE flashcards MPRE flashcards
1
Q

Durham-Humphrey Amendment

A

establishes the criteria for distinguishing prescription drugs from OTC drugs

legally establishes oral Rxs and refills

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What determines who may prescribe independently or in collaborative practice

A

Federal law leaves it up to states to decide

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Prescription Drug Marketing Act of 1987

A

bans the sale, trade, or purchase of prescription drug samples

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

To prevent counterfeiting, what does PDMA prohibit

A

reimportation of prescription drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Who instituted a policy to allow certain medications to be imported from other countries

A

FDA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Drug Quality and Security Act of 2013

A

addresses issues with meningitis outbreak that killed over 60 patients

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What are the 2 major sections of the drug quality and security act of 2013

A

Title I: compounding Quality Act

Title II: Drug Supply Chain Security Act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Title I: Compounding Quality Act

A

preserves and protects the practice of traditional pharmacy compounding in community pharmacies (made it legal to compound in community pharmacies)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Definition of compounding

A

taking 2 or more ingredients and combining them into a dosage form of a drug

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Who can compound according to traditional pharmacy compounding (503A)

A

a licensed pharmacist in a licensed pharmacy or a licensed physician authorized by state law to prescribe drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Traditional compounding

A

compounding a sterile or nonsterile drug for a specific patient based on a prescription

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Is it lawful to compound in anticipation of receiving prescriptions?

A

Yes, but only in limited quantities, Can only be dispensed with a valid prescription

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Which USP chapters must compounds comply with?

A

USP 795: non-sterile
USP 797: sterile
USP 800: hazardous drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Is it lawful to use a bulk substance to compound?

A

Yes, if it complies with the standards of an applicable USP or NF monograph, if a monograph exists

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What is the 503A Bulks List

A

a list being developed by the FDA that lists acceptable bulk drug substances which do not fall into the USP or NF monograph

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What are outsourcing facilities?

A

facility that compounds sterile drugs (can also compound non-sterile drugs); registration is voluntary

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What are outsourcing facilities allowed to do?

A

manufacture and send interstate shipments of larger quantities of compounded drugs without prescriptions being issued

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Are outsourcing facilities required to be a licensed pharmacy?

A

no, but they must be under the direct supervision of a licensed pharmacist

19
Q

Can outsourcing facilities use bulk drugs to compound?

A

yes, if the drug appears on a list published by the FDA OR the drug compounded from the bulk appears on the FDA drug shortage list

20
Q

Manufacturers of bulk substances used to compound must be registered with who?

A

the FDA. They must send a valid certificate of analysis with each bulk drug substance

21
Q

All ingredients used to compound must comply with what?

A

USP/NF standards

22
Q

Is it legal to compound a copy of a commercially available drug?

A

Depends; cannot compound copies of commercial drug product regularly or in inordinate amounts

23
Q

Can pharmacies compound “for office use only”

A

no, it’s illegal

24
Q

If you want to compound medications without a prescription, you must register as what?

A

an outsourcing facility

25
Q

Do hospitals need to register as outsourcing facilities?

A

No

26
Q

Title II: Drug Supply Chain Security Act

A

places unique product identifiers on individual drug packages and provide product and transaction information at each sale with lot level info, in paper, or electronic format

27
Q

What is the main goal of the Drug Chain Security Act

A

employ a track and trace program for prescription drugs only

28
Q

3 T’s of product tracing info

A

transaction history, transaction information, transaction statements

29
Q

How long must transaction records be maintained?

A

6 years

30
Q

Can a dispenser accept drugs from a trading partner who does not provide the transaction history?

A

no

31
Q

When is it appropriate for a dispenser to not provide any tracing information?

A

when the transfer is for a specific patient’s prescription, product returns, or intracompany distributions

32
Q

Which drug class did the FDA first issue regulations for providing patient package inserts?

A

oral contraceptive drugs

33
Q

What do patient package inserts require?

A

drug use, risks, and precautions

34
Q

Who’s duty is it to supply package inserts to patients?

A

the manufacturer and the pharmacist

35
Q

Are hospital pharmacies required to give patient package inserts?

A

Yes, the law still applies to hospital and inpatient settings

36
Q

How often are community pharmacies required to give patient package inserts?

A

each time the patient recieves their medication

37
Q

How often are institutional pharmacies required to give patient package inserts?

A

each time a medication is given; or with the first dose and every 30 days after

38
Q

What is Consumer Medication Information?

A

the drug leaflets/patient information materials provided with prescriptions dispensed by pharmacies

39
Q

What are MedGuides

A

patient information material for drugs posing a serious and significant concern to public health

40
Q

Who is responsible to dispense medguides?

A

the manufacturer and the pharmacist

41
Q

beyond-use date

A

the date after which a drug should not be used

42
Q

USP rules on beyond-use dates

A

the dispenser (pharmacy) shall place on the label of the prescription container a suitable BUD

43
Q

What is the expiration date on dispensed drugs?

A

1 year from the date dispensed or the expiration date from the manufacturer, whichever is first

44
Q

Is off-labe prescribing legal?

A

yes under the FDCA

Pharmacy Law (2 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions