Controlled Substance Act (Lecture 1)

What does the DEA mean by diversion

The movement of controlled substance from legitimate channels into illegal channels or uses

How does the DEA deter against diversions

Registration, fines, revocation, or suspension of registration and sentencing of individuals

Who decides how many controls will be produced in a year

The DEA

Closed System of Distribution

Includes schedules, registration, established quotas, arcos, security, record keeping, cyclic investigations

What is The Comprehensive Drug Abuse Prevention and Control Act

Act that gives the DEA oversight of controlled substances. Established the control classes. Set up the closed distribution system. They work in conjunction with FDA when it comes to scheduling and the Department of Justice. Also work with state boards of pharmacy.

Purpose of DEA registration

To ensure that each registrant is responsible for their part in monitoring controlled substances until they are dispensed to the patient.

State vs Federal Laws

States can be stricter but not more lenient than federal law.

How much is a DEA fine

$15,040 for EACH mistake made

Who must register with the DEA

Any location that has controlled substances. Anyone that administers, dispenses, or stores.

What needs to be checked on a control prescription

Does this prescriber have the authority to prescribe this medication?

Does this prescription have the necessary information to dispense?

What regulations (State and Federal) decide how the pharmacist fills the Rx?

If someone calls in a Rx and they don’t say the DEA # can the pharmacist write it in

No

What are DEA schedules based on

Potential for abuse and medical use

Who has the authority to decide what schedule a drug is placed in

Both the Attorney General and the Secretary of the Department of Health and Human Services. If the DHHS says a drug should not be controlled the AG can not go against that, however the reverse is not true. Whenever a manufacturer submits an NDA, one must go to AG and FDA.

What can the AG do if a drug is an “imminent Hazard”

Can schedule it as a CI to avoid harm to public safety. This has a 2 year expiration with a 1 year extension.

Schedule I CS

No accepted medical use.

Cannot be manufactured, prescribed, or dispensed except as approved by the DEA for investigational purposes. High potential for abuse.

Schedule II CS

High potential for abuse and abuse may lead to severe physical or psychological dependence. Tightly controlled.

Are all CIIs narcotics

No, some are stimulants (ADHD meds)

Schedule III CS

Lesser potential for abuse than CI or II drugs. Abuse may lead to moderate or low physical dependence of high psychological dependence. Includes many CII combination products with non-controlled ingredients.

DEA Exempted Prescriptions list

The statute lets the AG exempt a product if it is a compounded or finished product that contains a controlled substance but is unlikely to be abused or diverted. Simple differences like manufacturer and other ingredients can determine if a drug lands on this list. Ex: Fioricet and Fironol

Schedule IV CS

Lower potential for abuse than C-III drugs. May lead to limited physical or psychological dependence.

Holy trinity

Benzodiazepines, an opioid, and muscle relaxant

What benzodiazepines are CI (not FDA approved)

Clonazolam, Diclazepam, Etizolam, Flualprazolam, Flubromazolam

Schedule V CS

Low potential for abuse relative to CIV drugs. Abuse may lead to limited physical or psychological dependence relative to CIV-V drugs. Consist of preparations containing limited quantities of certain narcotics. Many states have different CV medications that are not federally scheduled

What must a CS have on it packaging/labeling

Labels and labeling of commercial containers of CS must contain identification symbol of the schedule.

Symbol must be prominently located on the label or labeling of the commercial container

Easily identified without having to take the bottle off the shelf

What does dispense mean

Deliver to ultimate user or research subject

Practiotioner

Person licensed, registered, or otherwise permitted by the US or the jurisdiction in which they practice.

Individual Practitioners

Include physicians, dentists, veterinarians, or other licensed to dispense by the state. Does not include pharmacist, pharmacy, or institutional practitioners.

Institutional Practitioners

A hospital or other entity other than an individual, licensed, registered, or otherwise permitted by the US or state in which it practices to dispense a CS in their professional practice, but does not include pharmacy.

What must come before registration application to DEA

A potential registrant must first have the states-controlled substance authority approval

Can a practitioner not have an individual registration but still prescribe CS?

Yes but they need to be agents of the institution and add their assigned suffix after the institutions DEA #

Do practitioners need more than one registration when prescribing from more than one office.

Yes if they store CS in different locations. If they only keep the CS in one office no.

Are pharmacies considered manufactuers

Not if they are engaged in ordinary pharmacy practices like compounding, repackaging, or relabeling. They may make their own dosage form of a medication that contains a narcotic as long as the narcotic makes up no more than 20% of the finished product.

Who are distributers

Wholesalers. Or anyone delivering CS that is not administering or dispensing it. Distributers must register with DEA. Practitioners are not considered distributors as long as they do not distribute more than 5% of total units of CS. Return of CS to wholesaler is exempt provided recordkeeping requirements are met. Distributors needs a Suspicious Order Monitoring System.

Suspicious Order Monitoring System (SORS)

Ensures that CS are not diverted into the illegal drug trade. If a suspicious order is identified, stop the shipment and they notify the DEA.

ARCOS

An automated, comprehensive drug reporting system which monitors the flow of DEA controlled substances form their point of manufacture to their dispensing.

What is tracked by ARCOS

CI and CII. CIII narcotics and GHB materials, some CII and IV psychotropic drugs.

What does DEA form 224 do

New registration for retail pharmacies, hospitals, practitioners, and mid-level practitioners

What does DEA form 224b do

Renewal form for chain pharmacies registration

What does DEA form 224M do

Registration for medical marijuana dispensaries

What does DEA form 225 do

Registration form for manufacturers, distributors, exporters, researchers

What does DEA form 363 Do

New registration for narcotic treatment programs

What does DEA form 510 do

New registration for handlers of List I chemicals

Renewal period for form 224/224b

3 years

Renewal period for 224m

1 year

Renewal period for 225

1 year

Renewal period for 363

1 year

Renewal period for 510

1 year

If registration is submitted prior to expiration can you continue dispensing controlled substances

Yes while renewal is pending

If registration is submitted after expiration ca you continue to dispense controlled substances

No because now the registration is expired. You have a 30 day window to be reinstated before you must go through the whole registration process again

What is DEA Form 223

This is what registrants get in return saying that they are registered. It must be on site and readily available.

Why might the DEA deny registration

Past behaviors, if you have charged or have been convicted.

When might the DEA suspend or revoke registration

If they catch you doing anything outside of the closed distribution system or if you are found to be falsifying records.

What if you business address changes

You must notify the DEA

What if you are terminating your

You must turn in certificate

What if you are transferring your business

Give 14 day’s notice