pharmacy law II exam I

What does DEA stand for?

Drug Enforcement Administration.

How many refills are allowed on a Schedule II prescription under federal law?

0

How many refills are allowed on a Schedule II prescription under Massachusetts law?

0

What is the federal quantity limit for a Schedule II prescription?

There is no federal quantity limit.

What is the maximum day supply for a Schedule II narcotic in Massachusetts?

30-day supply.

What is an example of a Schedule II narcotic?

OxyContin/oxycodone.

What is the maximum day supply for a Schedule II non-narcotic in Massachusetts?

90-day supply.

What is an example of a Schedule II non-narcotic?

Adderall.

What is the Massachusetts limit for a first-time Schedule II narcotic prescription?

7-day supply.

What is the exception to the 7-day limit for a first-time Schedule II narcotic prescription?

If the prescriber determines there is a medical reason requiring more than a 7-day supply.

What is the legal definition of a Schedule VI drug in Massachusetts?

An Rx-only legend drug that does not fall under Schedules I–V.

What is an example of a Schedule VI drug?

Ibuprofen 800 mg.

What wording identifies a prescription-only legend drug?

“Rx only.”

What is an example of a Schedule III drug?

Acetaminophen with codeine (Tylenol #3 or #4).

What schedule is Fiorinal?

Schedule III.

What schedule is Fioricet under Massachusetts law?

Schedule VI.

What schedule are anabolic steroids such as testosterone?

Schedule III.

What is the maximum day supply for testosterone in Massachusetts?

Up to a 90-day supply.

What schedule are benzodiazepines such as alprazolam, lorazepam, and diazepam?

Schedule IV.

What schedule is pregabalin?

Schedule V.

What schedule are certain cough products containing codeine?

Schedule V.

What schedule is diphenoxylate/atropine (Lomotil)?

Schedule V.

What does the expiration/validity of a Schedule II prescription in Massachusetts depend on?

Whether the prescription is in-state or out-of-state.

Within how many days must an out-of-state Schedule II prescription be written to be filled in Massachusetts?

Within the preceding 5 days.

Can an out-of-state Schedule II non-narcotic prescription come from any state?

Yes, as long as it was written within the preceding 5 days and the prescriber has appropriate DEA authorization.

Can an out-of-state Schedule II narcotic prescription come from any state?

no

Where can an out-of-state Schedule II narcotic prescription come from to be filled in Massachusetts?

A state contiguous with Massachusetts or Maine.

Within how many days must an out-of-state Schedule II narcotic prescription be written?

Within the preceding 5 days.

Which states are contiguous with Massachusetts?

New York, Vermont, New Hampshire, Rhode Island, and Connecticut.

Is Maine contiguous with Massachusetts?

No, but Massachusetts law still allows qualifying Schedule II narcotic prescriptions from Maine.

Can an out-of-state mid-level practitioner prescribe a Schedule II that is filled in Massachusetts?

Yes, as long as the practitioner has DEA registration authorizing the prescription.

Does a Massachusetts prescriber need a Massachusetts Controlled Substance Registration for Schedule VI drugs?

yes

Which schedules require a Massachusetts Controlled Substance Registration?

Schedules II–VI.

Which schedules require DEA registration for prescribing?

Schedules II–V.

Who needs to be registered with the DEA when handling controlled substances?

Prescribers, pharmacies/dispensers, and distributors/wholesalers.

Does a pharmacy need its own DEA registration?

Yes.

How often does a pharmacy's DEA registration expire?

Every 3 years.

Can a hospital resident without an individual DEA registration use the hospital's DEA registration?

yes

What does the first segment of an NDC number represent?

the manufacturer

What does the second segment of an NDC number represent?

the product

What does the third segment of an NDC number represent?

the package size

If a stock bottle expiration date only lists a month and year, when does the product expire?

The last day of that month.

If the manufacturer's expiration date is more than 1 year away, what beyond-use date is generally placed on the dispensed prescription?

1 year

If the manufacturer's expiration date is less than 1 year away, what beyond-use date is used?

The actual expiration date.

For which schedules is the federal transfer warning required?

Schedules II, III, and IV.

What does the federal transfer warning state?

Federal law prohibits transfer of the drug to anyone other than the patient for whom it was prescribed.

What happens if the federal transfer warning is placed on a Schedule V or VI prescription?

The drug is misbranded.

What is the difference between misbranding and adulteration?

Misbranding = problem with the label; adulteration = problem with the drug itself.

Can written prescriptions still be filled in Massachusetts?

Yes, certain exceptions allow written prescriptions.

What do the first letters of a DEA number indicate?

The type of prescriber/registrant.

What letter does a mid-level practitioner's DEA number begin with?

M

What does the second letter of a DEA number correspond to?

The prescriber's last name.

How long is an in-state Massachusetts Schedule II prescription valid?

30 days from the date written.

When counting the 30-day validity period of a Massachusetts Schedule II prescription, when is day 1?

The day after the prescription was written.

If a patient's address is missing from a prescription, can the pharmacist add it?

Yes, without contacting the prescriber.

If the patient's address is present but incorrect, can the pharmacist simply change it?

No; the prescriber or authorized agent must be contacted.

What information can NEVER be changed on a controlled substance prescription?

The patient's name or prescriber's name.

For most changes to a Schedule II prescription, who must the pharmacist contact?

The prescriber directly.

For changes to Schedule III–VI prescriptions, who may the pharmacist contact?

The prescriber or the prescriber's authorized agent.

Can a missing DEA number be added to a prescription?

Yes.

What is the maximum number of refills for Schedule III and IV prescriptions?

5

When does a Schedule V prescription expire under Massachusetts law?

6 months

When does a Schedule VI prescription expire in Massachusetts?

1 year from the date written.

What does EPT stand for?

Expedited Partner Therapy.

Can an EPT prescription be filled even if the partner did not personally see the prescriber?

Yes.

Is a patient's name and address required on a controlled substance prescription?

Yes, unless a specific exception applies.

Is a patient's date of birth legally required on a Massachusetts prescription?

no

Why is date of birth commonly included even though it is not legally required?

It is a best practice for patient identification, profiles, and insurance billing.

When must a new pharmacy complete its initial controlled substance inventory?

On the day it begins business, even if it has zero controlled substances.

If a new pharmacy has no controlled substances on opening day, what is recorded?

A zero inventory.

How often is the federal controlled substance inventory required?

Every 2 years.

For the biennial inventory, which schedules require an exact count?

Schedule I and II.

For Schedule III–V inventory, when is an exact count federally required?

When a container holds more than 1,000 dosage units.

How often must Massachusetts pharmacies count their Schedule II inventory?

At least once every 10 days

When should a full controlled substance inventory be performed when the manager of record changes?

At the change of manager so the outgoing and incoming managers establish the inventory on hand.

What is the 5% rule for a pharmacy distributing controlled substances?

A pharmacy may distribute up to 5% of its total controlled substances without registering as a distributor.

What DEA form is used to order Schedule I and II controlled substances?

DEA Form 222.

How are Schedule III–V controlled substances generally ordered?

By invoice.

What electronic system can be used to order controlled substances instead of a paper Form 222?

CSOS (Controlled Substance Ordering System).

Who automatically has authority to sign DEA Form 222?

The person who signed the pharmacy's most recent DEA registration.

What allows another employee to sign DEA Form 222?

A power of attorney.

Can a pharmacy technician legally sign DEA Form 222?

Yes, if granted power of attorney.

How long must controlled substance records generally be retained under federal law?

2 years.

What DEA form documents destruction of controlled substances?

DEA Form 41.

What is a reverse distributor?

A third party used to handle controlled substances for return/destruction.

When expired Schedule II drugs are transferred to a reverse distributor, whose Form 222 is used?

The reverse distributor's.

For Form 222 purposes, who completes/provides the Form 222?

The purchaser.

What DEA form is used to report theft or significant loss of controlled substances?

DEA Form 106.

How quickly must the DEA be notified of a theft or significant loss?

Within 24 hours.

Does DEA Form 106 apply to theft or loss of Massachusetts Schedule VI drugs?

no

If an employee diverts a Schedule VI drug in Massachusetts, who must be notified?

The Massachusetts Board of Pharmacy

How much employee diversion must occur before the Massachusetts Board of Pharmacy must be notified?

Any amount, even one tablet.

For a controlled substance lost in transit, who is responsible for reporting the loss?

The party that had custody and control of the drug when the loss occurred.

If a wholesaler's delivery is stolen before reaching the pharmacy, who reports the loss?

The wholesaler.

If the pharmacy accepts and signs for a controlled substance delivery and later discovers drugs are missing, who is responsible for reporting the loss?

The pharmacy.

How are expired Schedule III–V drugs transferred to a reverse distributor documented?

By invoice.

What should be done if a mistake is made on a paper DEA Form 222?

Void the form and keep it; do not erase or alter it.

How long must DEA Form 222 records be maintained?

2 years.

Who keeps the original paper DEA Form 222?

The supplier.

What must be done if a DEA Form 222 is lost or stolen?

Report it to the local DEA office.