PHA 373 - Georgia Controlled Substance Act L6

What law established the federal Controlled Substances Act?

Comprehensive Drug Abuse Prevention and Control Act of 1970.

What system did the Controlled Substances Act establish?

A closed system for manufacturing, distributing, and dispensing controlled substances.

How many schedules of controlled substances were created under the CSA?

Five schedules (I-V).

What factors determine how a drug is scheduled?

Abuse potential, pharmacologic effect, current scientific knowledge, history/pattern of abuse, scope/duration/significance of abuse, public health risk, dependence liability, and whether it is an immediate precursor.

What is a dangerous drug?

Any drug that may be dispensed by prescription only.

Are all prescription drugs dangerous drugs?

Yes.

What is a controlled substance?

A dangerous drug regulated into one of five schedules based on medical use, abuse potential, and dependence liability.

How is a controlled substance different from a dangerous drug?

A controlled substance is a dangerous drug with additional legal restrictions.

Who determines what is considered a dangerous drug or controlled substance in Georgia?

The Georgia Legislature.

Describe Schedule I (C-I).

High abuse potential, no accepted medical use in the U.S., and lack of accepted safety even under medical supervision.

Describe Schedule II (C-II).

High abuse potential with accepted medical use or use under severe restrictions.

Describe Schedule III (C-III).

Lower abuse potential than C-I/C-II, accepted medical use, moderate or low physical dependence and/or high psychological dependence.

Describe Schedule IV (C-IV).

Lower abuse potential than C-III, accepted medical use, limited physical and psychological dependence.

Describe Schedule V (C-V).

Lowest abuse potential of the schedules, accepted medical use, limited physical and psychological dependence.

Will the exam ask you to identify which schedule a specific drug belongs to?

No. Know the differences between the schedules instead.

How can combining drugs affect scheduling?

A combination product may be placed in a lower schedule because it has less abuse potential.

What is the purpose of the DEA?

To administer and enforce the Controlled Substances Act.

When was the DEA created?

1973.

Which agencies does the DEA commonly work with?

FDA, Georgia Board of Pharmacy (BOP), and Georgia Drug and Narcotics Agency (GDNA).

Who must register with the DEA?

Manufacturers, distributors, importers, exporters, researchers, pharmacies, physicians, laboratories, and narcotic treatment programs.

Do individual pharmacists register with the DEA?

No. They work under the pharmacy's DEA registration.

Which DEA form is used by pharmacies and physicians?

DEA Form 224.

Which DEA form is used by manufacturers, distributors, importers, exporters, and researchers?

DEA Form 225.

Which DEA form is used by narcotic treatment programs?

DEA Form 363.

What does "normal course of business" mean?

The prescription must match the practitioner's scope of practice and legitimate professional practice.

Give an example of a prescription outside the normal course of business.

A pediatrician prescribing controlled substances for adults or an OB/GYN prescribing large quantities of opioids to an adult male without justification.

Can hospitals allow practitioners to prescribe under the hospital's DEA registration?

Yes, if the practitioner is authorized, verified, and assigned a unique internal code.

Does a physician working in a hospital always need to use their personal DEA number?

No. The hospital's DEA registration may be used with a unique internal code.

What is a DEA registration number?

A unique identifier required to prescribe or dispense Schedule II-V controlled substances.

How many characters are in a DEA registration number?

Nine (2 letters and 7 numbers).

What letters may begin a DEA number for hospitals, practitioners, or pharmacies?

A, B, F, or G.

What letter begins a DEA number for mid-level practitioners?

M.

What letters begin a DEA number for distributors?

P or R.

What is the second letter of a DEA number usually based on?

The first letter of the registrant's last name (but not always).

How do you verify a DEA number?

Add the 1st, 3rd, and 5th digits; add the 2nd, 4th, and 6th digits and multiply by 2; add both totals; the ones digit must equal the last digit of the DEA number.

What DEA form is required to purchase Schedule I or II controlled substances?

DEA Form 222 or its electronic equivalent.

How many line items are allowed on a paper DEA Form 222?

20.

Is there a line limit on the electronic DEA Form 222?

No.

Who completes DEA Form 222 first?

The purchaser/pharmacy.

What color ink is used to complete a paper DEA Form 222?

Blue or black ink.

What does the purchaser do after completing DEA Form 222?

Makes a copy and sends the original to the supplier.

What does the supplier do after receiving DEA Form 222?

Fulfills the order, records their DEA number, keeps the original, and sends a copy to the DEA.

What does the purchaser record after receiving the shipment?

The quantity received and the date received on their copy.

Who may issue a controlled substance prescription?

An authorized practitioner who is registered (or exempt) and acting for a legitimate medical purpose in the usual course of professional practice.

Is a prescription issued outside the usual course of professional practice legal?

No.

Can physicians prescribe controlled substances for "office use only"?

No.

What is the purpose of the Georgia PDMP?

To reduce misuse and abuse, improve patient care, and reduce duplicate prescribing and overprescribing.

Who may access the PDMP?

Prescribers, pharmacists, and up to two authorized staff members per shift assisting with patient care.

What are common red flags for controlled substance misuse?

Altered prescriptions, cash payments, early refill requests, multiple prescribers, distant prescribers, opioid/benzodiazepine/carisoprodol cocktails, and pattern prescribing.

How should a pharmacist respond to controlled substance red flags?

Review the PDMP, communicate with prescribers or pharmacists, verify legitimacy, refuse to dispense if appropriate, and report suspected violations when necessary.

What are prescribers required to do regarding the PDMP?

Register if prescribing controlled substances and review the PDMP initially and at least every 90 days unless an exception applies.

When is PDMP review NOT required for prescribers?

≤3-day supply (≤26 tablets/capsules), hospitalized patients, outpatient surgery prescriptions ≤10 days and ≤40 tablets/capsules, hospice/terminal illness, or cancer treatment.

What are dispensers required to do regarding the PDMP?

Report controlled substance dispensing within 24 hours and protect PDMP confidentiality.

Are pharmacists required to check the PDMP before dispensing?

No, but they should.

What should pharmacists do if they suspect misuse or diversion?

Communicate concerns and report suspected violations to GDNA or the Board of Pharmacy when appropriate.

What was the purpose of the Combat Methamphetamine Epidemic Act of 2005?

To reduce access to methamphetamine ingredients.

Which ingredients are regulated under the Combat Methamphetamine Epidemic Act?

Ephedrine, pseudoephedrine (PSE), and phenylpropanolamine (PPA).

Who must approve pseudoephedrine sales?

A pharmacist.

Where must pseudoephedrine products be stored?

In the pharmacy prescription department.

Must pharmacists complete the pseudoephedrine sale themselves?

No. They only have to approve the sale.

What is the maximum amount of pseudoephedrine that may be purchased in 24 hours?

3.6 grams.

What is the maximum amount of pseudoephedrine that may be purchased in 30 days?

9 grams.

What is the 30-day mail-order limit for pseudoephedrine?

7.5 grams.

How must non-liquid pseudoephedrine products be packaged?

In blister packs containing no more than 2 dosage units per pack.

How long must pseudoephedrine sales records be maintained?

Two years.

What information must be verified before selling pseudoephedrine?

A valid government-issued photo ID.

What information must the seller record for pseudoephedrine sales?

Purchaser's name, address, date and time of sale, signature, product sold, and amount sold.

What is Georgia's Controlled Substance Act?

Title 16, Article 13 of Georgia law regulating controlled substances within the state.

What is the difference between the federal Controlled Substances Act and Georgia's Controlled Substance Act?

The federal CSA establishes national regulation of controlled substances, while Georgia's Controlled Substance Act (Title 16) governs controlled substances under Georgia law.

What is Georgia pharmacy law?

Title 26 of the Georgia Code.

Can controlled substances be prescribed for office use?

No. Controlled substance prescriptions may only be issued for a legitimate patient and legitimate medical purpose.