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Spring 2022: Pharmacy Law > Reading 9 > Flashcards

Reading 9 Flashcards

Covers DEA registration.

You may prefer our related Brainscape-certified flashcards:
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1
Q

What are the 10 types of federal registration?

A
  1. manufacturing
  2. distributing
  3. reverse distributing
  4. dispensing or instructing
  5. research (I)
  6. research (II-V)
  7. narcotic treatment program including compounder
  8. importing
  9. exporting
  10. chemical analysis
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2
Q

When is registration required?

A

before a person can “engage in any activity for which registration is required”

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3
Q

True or false: each pharmacy owned by a company needs its own registration.

A

true; a separate registration is required for each place of business or professional practice location where controlled substances are held

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4
Q

True or false: a prescriber may need to register multiple practice sites if they keep controlled substances there.

A

true

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5
Q

Who fills out DEA Form 224 for registration?

A
  • retail pharmacy
  • hospital/clinic
  • practitioner
  • teaching institution
  • mid-level practitioner
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6
Q

Who fills out DEA Form 225 for registration?

A
  • manufacturer
  • distributor
  • researcher
  • analytical laboratory
  • importer
  • exporter
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7
Q

Who fills out DEA Form 363 for registration?

A

narcotic treatment programs

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8
Q

Who fills out DEA Form 510 for registration?

A

domestic chemical

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9
Q

In most cases, registrations must be renewed annually; what is the exception to this tule?

A

the “dispensing or instructing” registration type (valid for 3 years)

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10
Q

Who fits into the “dispensing or instruction” registration type?

A
  • practitioners
  • pharmacies
  • clinics
  • hospitals
  • teaching institutions
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11
Q

What two factors are registration based on?

A
  • schedules of drugs handled
  • activities the drugs are engaged in
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12
Q

What is the true definition of “dispense”?

A

delivering “a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery.”

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13
Q

True or false: prescribing a controlled substance is basically considered to be dispensing a controlled substance (in the legal sense)

A

true; this is why prescribers end up in the “dispenser” category of registration

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14
Q

What are coincident activities?

A

extra activities that a DEA registrant can engage in without obtaining an additional registration; functions that the registrant needs to do to complete their primary registered function

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15
Q

What is the controlled substance limit pharmacies are allowed to distribute before they must obtain a separate registration for distribution?

A

up to 5% of their total amount of controls dispensed

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16
Q

What coincident activities are allowed for dispensing or instructing registrants?

A
  • May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute.
  • A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound or mixture.
  • A retail pharmacy may perform central fill pharmacy activities.
17
Q

Which registration categories have NO coincident activities?

A
  • reverse distributing
  • narcotic treatment program
  • exporting
18
Q

Where are DEA numbers used in practice?

A
  • order forms to the DEA
  • reports to the DEA
  • controlled substance prescriptions
19
Q

What is the DEA number format?

A

9 characters; 2 letters followed by 7 numbers

20
Q

What is the only way to guarantee that a given DEA number is valid?

A

DEA verification site

21
Q

Whose DEA number may start with an A, B, F, or G?

A

one of the Big Four prescribers OR any dispensing/instructing registrant (i.e., a pharmacy)

22
Q

Whose DEA number may start with the letter M?

A

mid-level practitioner

23
Q

Whose DEA number may start with a P or R?

A

distributor

24
Q

What does the second letter in the DEA number indicate?

A

first initial of the prescriber’s last name OR first initial of the business name (be conscientious of name changes, though)

25
Q

How can you verify that a DEA number’s actual digits are correct?

A
  1. Add the 1st, 3rd, and 5th digits together
  2. Add the 2nd, 4th, and 6th digits together and multiply by 2
  3. Add the result from step 1 and step 2
  4. Determine if the right-most digit from step 3 matches the DEA number’s final digit (the check digit).
26
Q

When might registration requirements be exempted for certain entities?

A
  • agent/employee of a registered person (i.e., pharmacist may not need a registration since their pharmacy is registered)
  • common or contract carriers (i.e., UPS, FedEx, USPS)
  • an “ultimate user who possesses such substance” (i.e., the patient)
  • armed services, public health service, bureau of prisons, and other law enforcement
27
Q

Does a pharmacy within an institution need their own registration?

A

no; they can dispense on the institution’s DEA number

28
Q

How would an ultimate user legally import/export a controlled substance for personal medical use?

A
  • must be in original container in which it was dispensed
  • must declare on Customs form
  • must bring no more than 50 dosage units into the US
29
Q

Individual practitioners may dispense, administer, or prescriber controlled substances under an institutional DEA number, as long as they follow which 6 rules?

A
  1. it’s done in the usual course of their professional practice
  2. they are permitted to administer/dispense/prescribe by their jurisdiction
  3. their institution has verified that they are permitted to dispense/administer/prescribe drugs within their jurisdiction
  4. the practitioner is acting only within the scope of their employment in the institution
  5. the institution authorizes the practitioner to administer/dispense/prescribe under the hospital DEA number and uses a specific internal code to the DEA number for each practitioner authorized
  6. the institution keeps a current list of internal codes and the practitioners they match for verification purposes

Spring 2022: Pharmacy Law (20 decks)

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