Reading 9 Flashcards
Covers DEA registration.
What are the 10 types of federal registration?
- manufacturing
- distributing
- reverse distributing
- dispensing or instructing
- research (I)
- research (II-V)
- narcotic treatment program including compounder
- importing
- exporting
- chemical analysis
When is registration required?
before a person can “engage in any activity for which registration is required”
True or false: each pharmacy owned by a company needs its own registration.
true; a separate registration is required for each place of business or professional practice location where controlled substances are held
True or false: a prescriber may need to register multiple practice sites if they keep controlled substances there.
true
Who fills out DEA Form 224 for registration?
- retail pharmacy
- hospital/clinic
- practitioner
- teaching institution
- mid-level practitioner
Who fills out DEA Form 225 for registration?
- manufacturer
- distributor
- researcher
- analytical laboratory
- importer
- exporter
Who fills out DEA Form 363 for registration?
narcotic treatment programs
Who fills out DEA Form 510 for registration?
domestic chemical
In most cases, registrations must be renewed annually; what is the exception to this tule?
the “dispensing or instructing” registration type (valid for 3 years)
Who fits into the “dispensing or instruction” registration type?
- practitioners
- pharmacies
- clinics
- hospitals
- teaching institutions
What two factors are registration based on?
- schedules of drugs handled
- activities the drugs are engaged in
What is the true definition of “dispense”?
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.”
True or false: prescribing a controlled substance is basically considered to be dispensing a controlled substance (in the legal sense)
true; this is why prescribers end up in the “dispenser” category of registration
What are coincident activities?
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
What is the controlled substance limit pharmacies are allowed to distribute before they must obtain a separate registration for distribution?
up to 5% of their total amount of controls dispensed
What coincident activities are allowed for dispensing or instructing registrants?
- 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.
Which registration categories have NO coincident activities?
- reverse distributing
- narcotic treatment program
- exporting
Where are DEA numbers used in practice?
- order forms to the DEA
- reports to the DEA
- controlled substance prescriptions
What is the DEA number format?
9 characters; 2 letters followed by 7 numbers
What is the only way to guarantee that a given DEA number is valid?
DEA verification site
Whose DEA number may start with an A, B, F, or G?
one of the Big Four prescribers OR any dispensing/instructing registrant (i.e., a pharmacy)
Whose DEA number may start with the letter M?
mid-level practitioner
Whose DEA number may start with a P or R?
distributor
What does the second letter in the DEA number indicate?
first initial of the prescriber’s last name OR first initial of the business name (be conscientious of name changes, though)
How can you verify that a DEA number’s actual digits are correct?
- Add the 1st, 3rd, and 5th digits together
- Add the 2nd, 4th, and 6th digits together and multiply by 2
- Add the result from step 1 and step 2
- Determine if the right-most digit from step 3 matches the DEA number’s final digit (the check digit).
When might registration requirements be exempted for certain entities?
- 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
Does a pharmacy within an institution need their own registration?
no; they can dispense on the institution’s DEA number
How would an ultimate user legally import/export a controlled substance for personal medical use?
- 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
Individual practitioners may dispense, administer, or prescriber controlled substances under an institutional DEA number, as long as they follow which 6 rules?
- it’s done in the usual course of their professional practice
- they are permitted to administer/dispense/prescribe by their jurisdiction
- their institution has verified that they are permitted to dispense/administer/prescribe drugs within their jurisdiction
- the practitioner is acting only within the scope of their employment in the institution
- 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
- the institution keeps a current list of internal codes and the practitioners they match for verification purposes
