Federal Pharmacy Law and Regulation: Reading 3

Question 1

the ________ ____________ amendment of ________:

1) established and defined what qualities make a drug a prescription drug, and WHO is allowed to prescribe these drugs

2) allowed both written and oral rxs from prescribers, meaning prescribers were now able to call-in rxs over the phone

3) allowed refills on rxs, whereas previously refills rxs could only be filled once

Answer 1

Durham-Humphrey Amendment of 1951

Question 2

Prescribing authority is defined by:

Answer 2

states and other jurisdictions, NOT the federal government

**discussed here as a general overview of who can and can’t prescribe (this deck is a general federal idea, NOT indiana law)

Question 3

Who are considered the BIG FOUR prescribers which are recognized in ALL states and jurisdictions?

Prescriptions written by these practitioners are accepted and filled in any part of the United States as long as the prescriber is licensed in at least one jurisdiction, meaning state or territory, of the United States.

Answer 3

Physicians (MD/DO)
Dentists (DDS/DMD)
Podiatrists (DPM)
Veterinarians (DVM)

“Big Four”

Question 4

__________ ___ _________ is best described as what a practitioner can do within their practice, based on their education and professional licensure

Answer 4

Scope of practice

**a general rule is that practitioners are only permitted to prescribe within their scope of practice

Question 5

Physician’s scope of practice:

Answer 5

Whole body responsibility

Question 6

T or F?

Physicians when specialized can only prescribe in that specialty.

Answer 6

FALSE -

** physicians may choose to specialize in a particular area, but this specialization does NOT take away their education, licensure, and ability to prescribe whatever they want.

ie. internal medicine, but ALSO surgeons! even tho they specialize in surgery, they aren’t required to only prescribe for only surgical issues or surgical patients)- we may want to know more about why a surgeon is prescribing Adderall for a patient, and we may even refuse to refill this prescription based on the physician’s reasoning, but it’s not illegal.

Question 7

Dentists scope of practice:

Answer 7

dentists education only involves the mouth and maxillofacioual area; therefore, dentists can prescribe medications for these areas, related structures, and conditions affecting these areas:

pain meds for toothache, antibiotic (amoxicillin, cephalexin, augmentin) for gum infection, denzodiazepine for dental anxiety = ALL ACCEPTABLE

HOWEVER, an antibiotic for an upper respiratory infection (azithromycin) = NOT ACCEPTABLE = call dentist for further info

Question 8

Podiatrists scope of practice:

Answer 8

treat feet, ankles, and in some jurisdictions, hands (refer to state of licensure)

Podiatrists are much more likely to stay within their scope than dentists (one controversy- podiatrist using heart drug to affect edema in the ankle: would you dispense? something to consider)

Question 9

Veterinarian scope of practice:

Answer 9

can only prescribe for animals: they are allowed to prescribe human drugs for animals or animal drugs.

No limitations on the types of drugs they can use as long as those drugs are prescribed for an animal. (some weird requirements for DISPENSING in Indiana)

Question 10

Midlevel practitioner scope of practice:

Answer 10

More difficult to determine compared to the big four.

NP and PAs are usually limited to the specialty of their supervising physician – this means, under internal medicine dr= wide scope, whereas for derm= only prescribe drugs related to derm issue.

some midlevel prescribers are sometimes limited to a specific formulary of drugs they’re allowed to prescribe ** refer to state.

Question 11

Federal law-
To be exempted and not considered misbranded, the rx label MUST contain all of the following:
1)
2)
3)
4)
5)
6)
7)

Answer 11

1. The name AND address of the dispenser.
2. Serial number of the prescription.
3. Date of the rx OR its filling date
4. Name of the prescriber.
5. IF STATED ON THE RX, the name of the patient
6. IF CONTAINED ON THE PRESCRIPTION, any directions for use.
7. IF CONTAINED ON THE PRESCRIPTION, any cautionary statements.

(5-7 NOT ALWAYS REQUIRED BY FEDERAL LAW!)

Question 12

For an rx that was filled at a central pharmacy, according to federal law, which address would be on the rx label?

Answer 12

the label would contain the address of the pharmacy dispensing it to the patient.

Question 13

FEDERAL REFILL RULES:

OTC, Non-control: how long can a prescription be refilled?

Answer 13

No rule*

*different than indiana

Question 14

FEDERAL REFILL RULES:

Rx-only, non-control: how long can a prescription be refilled?

Answer 14

No rule*

*different than indiana

Question 15

FEDERAL REFILL RULES:

OTC or Rx-only, CIII, CIV, CV: how long can a prescription be refilled?

Answer 15

6 months

Question 16

FEDERAL REFILL RULES:

OTC, non-control: how many refills are allowed?

Answer 16

No rule

Question 17

FEDERAL REFILL RULES:

OTC or Rx-only, CIII, CIV, CV: how many refulls are allowed?

Answer 17

5#

Question 18

FEDERAL REFILL RULES:

OTC, non-control: When does the expiration clock start ticking?

Answer 18

No rule*

*different than indiana

Question 19

FEDERAL REFILL RULES:

Rx-only, non-control: when does the expiration clock start ticking?

Answer 19

no rule*

*different than indiana

Question 20

FEDERAL REFILL RULES:

OTC or Rx-only, CIII, CIV, CV: when does the expiration clock start ticking?

Answer 20

Dated Issued

Question 21

INDIANA REFILL RULES:

OTC, Non-control: how long can a prescription be refilled?

Answer 21

1 year*

*differs from federal law

Question 22

INDIANA REFILL RULES:

Rx-only, non-control: how long can a prescription be refilled?

Answer 22

1 year*

*differs from federal law

Question 23

INDIANA REFILL RULES:

OTC or Rx-only, CIII, CIV, CV: how long can a prescription be refilled?

Answer 23

6 months

Question 24

INDIANA REFILL RULES:

Rx-only, CII: how long can a prescription be refilled?

Answer 24

1 year*

*differs from federal law (not defined)

Question 25

INDIANA REFILL RULES:

OTC, non-control: how many full refills are allowed?

Answer 25

No rule

Question 26

INDIANA REFILL RULES:

Rx-only, non-control: how many full refills are allowed?

Answer 26

No rule

Question 27

INDIANA REFILL RULES:

OTC or Rx-only, CIII, CIV, CV: how many full refills are allowed?

Answer 27

5#

Question 28

INDIANA REFILL RULES:

OTC, Non-control,

Rx-only, non-control,

OTC or Rx-only, CIII, CIV, CV,

RX-only, CII

When does the expiration clock start ticking?

Answer 28

DATE ISSUED*

Differs from federal law (only starts ticking for OTC/Rx-only CIII, CIV, CV; not defined for CII)

Question 29

Indiana law:

Non-controlled medications are refillable any number of times up to _____ from the date written.

Answer 29

1 year

Question 30

Indiana law:

Both Rx-only and OTC controlled medications in schedules III, IV, and V are refillable no more than ____ times up to ___ months from the date written.

Answer 30

5 times

6 months

Question 31

Schedule II medications are not refillable but can be filled up to _______ from the date written.

Answer 31

1 year.

Question 32

Scenario:

A patient cannot afford to purchase the full 30 tablets the prescription was written for (or they prefer 90 day supply) - can you dispense the prescription in the way the patient wants/different quantity than the face amount?

Answer 32

Yes, for a NON-CONTROLLED medication.

if an rx is written for 30 tablets with 10 refills, it’s written for 330 tablets. It can be dispensed one tablet at a time or all at once, or any other combo, as long as its dispensed before the expiration date of the rx.

Question 33

the _________ is found on most legend drug containers and helps us identify that a product is what we’re expecting.

Answer 33

national drug code (NDC)

• it is something requested by the FDA but is not a mandatory requirement for labeling

Question 34

NDC:

the first 5 digits in the number represent:

Answer 34

the manufacturer

(5-4-3); sometimes leading zeros are dropped off.

Question 35

NDC:

the second 4 digits in the number represent:

Answer 35

the drug

Question 36

NDC:

the third 2 digits represent:

Answer 36

package size

Question 37

__________ describes situations where one person authorizes a second person to deal with a third person on their behalf.

Answer 37

agency

Question 38

the “principal” is the person who delegates authority to an agent. In healthcare, this is considered to be:

Answer 38

the prescriber

the “agent” is an individual who is completing tasks that require legal authority to complete and that the individual does not have on their own - such as a nurse working under the prescriber.

Agency law allows a nurse to call in a prescription, clarify a prescription, and complete other tasks on behalf of the prescriber.

Question 39

T or F?

Authorized agents may call in non-controlled AND controlled medications, but the prescriber MUST be the one who determined that the patient needed the medication and the prescriber MUST specify all the elements of the prescription to the agent.

Answer 39

True.

ex: prscriber can’t just say “call in amoxicillin rx for mrs. smith”; they MUST say/write “call in a prescription for mrs. jane smith (dob0 for amoxicillin 500mg capsules, twice daily for 10 days, number 20)

Question 40

T or F?

Agents can call in CIIs.

Answer 40

CIIs CANT BE DELEGATED TO AN AGENT, only very few cases its allowed – an agent is allowed to fax CII in the few cases it is allowed***