4. Closed System of Controlled Substance Distribution

What primary federal law regulates controlled substances?

The Controlled Substances Act (CSA) of 1970

What are the four activities regulated by the Controlled Substances Act (CSA)?

1. manufacturing

2. distribution

3. dispensing

4. management of opioid treatment programs (OTP)

What does it mean to have a "closed system" of manufacturing, distributing, and dispensing controlled substances?

There is no outside intervention and all controlled substances are accounted for

What is the federal entity responsible for administering the CSA?

Drug Enforcement Administration (DEA)

Which schedule does not have to have an accepted medical use?

I

Which 2 schedules have a high potential for abuse?

1. I

2. II

Which schedule has a moderate potential for abuse?

III

Which 2 schedules have a low potential for abuse?

1. IV

2. V

Which 2 schedules have potential for severe dependence?

1. I

2. II

Which schedule has potential for moderate to low dependence?

III

Which schedule has potential for low dependence?

IV

Which schedule has potential for very low dependence?

V

The CSA grants the authority to schedule, reschedule, or unschedule a drug to the

Attorney General

The Attorney General must consult the _____________ for recommendations on scheduling drugs.

Secretary of the Department of Health and Human Services

The Attorney General may temporarily place a drug in schedule I for what reason without consulting the Secretary of the Department of Health and Human Services?

the drug is an imminent hazard to public safety

The secretary of H.H.S must notify the attorney general if a ________________ for any drug that has a stimulant, depressant, or hallucinogenic effect.

manufacturer submits a new drug application

What does the symbol look like required by the CSA to be placed on the label of the commercial container of drugs in schedules C-I through C-V?

C with a roman numeral inside

Who are the entities that must register with the Drug Enforcement Administration (DEA) before engaging in activities involving controlled substances?

1. prescribers

2. hospitals

3. pharmacies

4. research investigators

Who are the 11 entities that are exempt from registering with the Drug Enforcement Administration (DEA) before engaging in activities involving controlled substances?

• Common carriers (eg, FedEx, UPS, trucking companies, railroads)

• Agents/employees of registered manufacturers, distributors, or dispensers

• Ultimate users (eg, patients with legal prescriptions)

• Officials of the Armed Forces, the Public Health Service, and Bureau of Prisons who arE in the usual course of their official duties

How often manufacturers, distributors, and opioid treatment programs (OTP) must renew their DEA registrations?

annually

How often dispensers must renew their DEA registrations?

every 3 years

__________ includes wholesalers and reverse distributors but that do not administer or dispense.

Distributing

A ___________ delivers a controlled substance to an ultimate user (ex: patient) or research subject by a pursuant to the lawful order of a practitioner, including prescribing, administering, packaging, labeling or compounding to prepare for such delivery.

Dispenser

Who are 4 examples of dispensers?

1. prescribers

2. hospitals

3. pharmacies

4. research investigators

The DEA registration begins with what 4 letters for a dispenser (physician, hospital, pharmacy, and researchers)?

1. A

2. B

3. F

4. G

The DEA registration begins with what letter for a mid-level practitioner (nurse practitioner and physician assistant)?

M

The DEA registration begins with what 2 letters for a distributor (manufacturer, wholesaler, and reverse distributor)?

1. P

2. R

What are the 4 steps to determine the potential validity of the number by calculation?

1. add digits 1, 3 and 5

2. add digits 2, 4, and 6 then multiply by 2

3. add steps 1 and 2

4. the last digit of the sum should match the final digit of the identifier

What are the 3 steps of the process to be followed in the event a DEA registrant dies, ceases legal existence, or discontinues business/practice?

1. notify DEA

2. registration is returned to DEA

3. controlled substances must be transferred to another registrant or destroyed

The Attorney General may deny, revoke, or suspend a registration if

registration would not be in the public interest.

DEA regulations require that all registrants provide effective controls and procedures to guard against

theft and diversion of controlled substances

All practitioners must store schedule ___ drugs in a securely locked and substantially constructed cabinet.

I

Prescribing practitioners (physicians and nurse practitioners) must store schedule ___ drugs in a securely locked and substantially constructed cabinet.

II

In what 2 places can pharmacies (retail and hospital) store schedule II drugs?

1. locked cabinet

2. dispersed throughout the stock of legend drugs

Summarize the storage requirements imposed on non-practitioners?

More stringent security regulations than practitioners

What are the 2 acts that would constitute a drug trafficking offense under the CSA?

1. manufacture, distribute, or dispense

2. possessing with intent to manufacture, distribute, or dispense

A recordkeeping violation is a ________ offense if the agent had the knowledge or intent to fail to make and keep required records.

criminal

A recordkeeping violation is a ________ offense if the agent was negligent when they failed to make and keep required records.

civil

Failing to complete a DEA Form 222 for schedule ___ and ____ drugs is a criminal offense.

I and II

_________ or _______ possessing a controlled substance without a valid prescription is considered illegal possession.

Knowingly or Intentionally

What 5 statements the must be contained in a Notice of Inspection of Controlled Premises issued by the DEA in order to conduct an inspection?

1. owner or PIC has a constitutional right to refuse consent

2. incriminating evidence may be seized and used in criminal prosecution

3. notice of inspection must be presented

4. consent is voluntary and not coerced

5. consent may be withdrawn at anytime during inspection

An administrative inspection warrant (AIW) is issued by a judge on the showing of _________ which is that there is valid public interest.

probable cause

The probable cause requirement for a __________ (administrative inspection/search) warrant is more stringent.

search

What are the 3 circumstances that would meet the probable cause requirement for obtaining an AIW?

1. large purchases of controlled substances

2. a need to ensure compliance and recordkeeping

3. passage of substantial period of time since last inspection

What are the 5 situations when an AIW or search warrant is not needed?

1. initial inspection

2. have a subpoena

3. consent is given by owner or lead pharmacist

4. imminent danger

5. lack of time or opportunity to get one

When can an AIW be served?

during regular buisness hours

When can a search warrant be served?

at any time

What are the 2 potential penalties for refusing to permit the execution of an AIW?

1. jail for 1 year

2. fine of up to $25K

What are the 3 qualifying circumstances under which the Controlled Substance Registrant Protection Act of 1984 (CSRPA) would mandate that a federal investigation be carried out?

1. replacement cost is over $500

2. death or significant injury (blood or bone)

3. interstate or foreign commerce

________ is illegal entry into a building with the intent to commit a crime therein.

burglary

_________ is illegal taking of property by force or threat of force.

robbery

What are the 2 qualifying crimes in which the Controlled Substance Registrant Protection Act of 1984 (CSRPA) would mandate that a federal investigation be carried out?

1. burglary

2. robbery

What 2 items must be present to determine whether a federal investigation must be carried out under the terms of the Controlled Substance Registrant Protection Act of 1984?

1. qualifying crime

2. qualifying circumstance

What are the 3 specific drugs placed by the Combat Methamphetamine Epidemic Act (CMEA) into the category of the CSA known as "scheduled listed chemical products" (SLCP)?

1. Pseudoephedrine (PSE)

2. ephedrine

3. phenylpropanolamine (PPA)

What is the daily limit on the purchase of SLCP as mandated by CMEA federally?

3.6 g

What is the daily limit on the purchase of SLCP as mandated by CMEA in Alabama?

3.6 g

What is the 30-day limit on the retail purchase of SLCP as mandated by CMEA federally?

9 g

What is the 30-day limit on the retail and mail order purchase of SLCP as mandated by CMEA in Alabama?

7.5 g

What is the 30-day limit on the mail order purchase of SLCP as mandated by CMEA federally?

7.5 g

What are the retail storage requirements for SLCP as mandated by CMEA federally?

behind the counter or in a locked cabinet

What are the retail storage requirements for SLCP as mandated by CMEA in Alabama?

behind the counter

What 5 pieces of information are included in the recordkeeping requirements for the sale of SLCP as mandated by the CMEA both federally and in Alabama?

1. product name

2. quantity sold in g

3. name and address of purchaser

4. date and time of sale

5. purchaser signature

How should the record be kept for the sale of SLCP as mandated by the CMEA federally?

does not specify

How should the record be kept for the sale of SLCP as mandated by the CMEA in Alabama?

electronically

If pursuant to Notice of Inspection,

determine whether you will give consent.

If pursuant to Administrative Inspection Warrant or search warrant,

do not attempt to obstruct the search

Note the _____ of the official conducting the search.

name and credentials

____. Say as little as possible.

Do not lie

Contact the _____ at the earliest opportunity.

pharmacy owner and an attorney

Do not sign any document that

you have not read and fully understood