Controlled Substances Scheduling, DEA Registration, and Inventory Procedures

Schedule I

•No current accepted medical use

•High potential for abuse

•High potential for physical dependance

•High potential for psychological dependence

Schedule II

•Has current accepted medical use with restrictions

•High potential for abuse

•High potential for physical dependence

•High potential for psychological dependance

Schedule III

•Currently has accepted medical use

•Potential for abuse is less than schedule I and II

•Potential for physical dependence is moderate to low

•High potential for psychological dependence

Schedule IV

•Has current accepted medical use

•Has low potential for abuse

•Has limited potential for physical dependence

•Has limited potential for psychological dependence

Schedule V

•Current accepted medical use

•Low potential for abuse

•Limited potential for physical dependence

•Limited potential for psychological dependence

Schedule II

Any combination product containing MORE than 90 mg of codeine per dosing unit

Schedule II

Codeine sulfate tablets

Schedule II

Any combination preparation containing MORE than 1,800mg of Codeine per 100 mL

Schedule III

Combination products containing 90mg of Codeine per dosage unit of LESS (Ex. Tylenol #3, Tylenol #4, Fiorcet w/codeine)

Schedule III

Combination preparations containing 1,800mg of codeine per 100mL or less

Schedule V

Combination cough preparations with 200mg of codeine per 100mL or less (Robitussin AC, Phenergan w/codeine, etc)

Schedule II

Amobarbital

Schedule II

Pentobarbital

Schedule II

Secobarbital

Schedule III

Amobarbital (combination product w/non-controlled active ingredient or suppository formulation)

Schedule III

Pentobarbital (combination product w/non-controlled active ingredient or suppository formulation)

Schedule III

Secobarbital (combination product w/non-controlled active ingredient or suppository formulation)

Schedule IV

Phenobarbital

True

T/F?

All commercial containers of controlled substances must be labeled with identification symbols of the designated schedule the drug has been placed, and it must be prominent

Every 3 years

How often should the pharmacy renew their DEA registration?

An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance if such agent or employee is acting the the usual course of his/her business or employment

Under the CSA which person(s) are exempt from DEA registration?

DEA form 224

By which DEA from do pharmacies register with the DEA?

DEA 224a

What is the DEA renewal from for pharmacies?

Yes, each separate location requires one. Large healthcare entities can request a "campus registration" on a case-by-case basis

Do separate locations/branches need different DEA registrations?

•The applicant (if for individual)

•A partner (if for partnership)

•An officer (if for a corporation)

Who must applications for registration be signs (written or electronically) by?

By filling out a "power of attorney" with the DEA

How can applicants authorize another individual to sign applications/renewals?

Biennially (Every 2 years)

How often does controlled substance inventory need to be done?

Hospital, Clinic, Practitioner, Teaching institution, and pharmacy

DEA registrant type that begins with A/B/F is for which professions?

Department of Defense Contractors

DEA registrant types that begin with G is for which professions?

Mid level practitioners (APRN, PAs, NPs, etc)

DEA registrant types that begin with M is for which professions?

Manufacturer, distributor, researcher, analytical lab, importer, exporter, reverse distributor, narcotic treatment program

DEA registrant type that begins with P/R is for which professions?

•Addition of digits 1,3, and 5

•Addition of digits 2,4, and 6 (multiplied by 2)

•Add the results of the two numbers above and the last number of the summation should be equal to the last number in the DEA

How can DEA numbers be verified?

False, penalties can range from years of imprisonment to life with fines up to millions of dollars.

T/F?

Practitioners cannot be prosecuted as drug traffickers.

Illegal possession

Any person knowingly/intentionally possessing a controlled substance (except with a valid prescriptions) faces up to 1 year in prison and/or fine of up to $1,000

The inspector is required to state the purpose of the inspection and present to the owner/pharmacist in charge the inspecting agent's credentials and a written notice of inspection. The owner must consent to inspection w/o administrative inspection warrant (AIW)

What must an inspector do before a pharmacy inspection?

DEA form 222

Which DEA form is required for the sale or transfer of schedule II drugs (except dispensing to the ultimate user)?

No, only schedule II

Is a DEA form required to order all controlled substances?

By creating a "power of attorny" that must be maintained in the pharmacy (does not have to be filed with the DEA)

How may a registrant authorize other individuals to execute DEA 222 forms?

10/30/2021

When was the DEA triplicate form phased out?

Retained by the supplier; brown

Who keeps the copy 1 of the DEA 22 form and what color is it?

Sent to the DEA; green

Who keeps copy 2 of the DEA 222 form and what color is it?

Retained by the purchaser; blue

Who keeps copy 3 of the DEA 222 from and what color is it?

•Controlled Substance ordering system (CSOS)

•Provides an electronic equivalent of DEA form 222

•Also allows for ordering of controlled substances outside of just schedule II

Which system is used to order controlled substances?

•In a locked cabinet with pull out shelves

•Dispersed alphabetically within pharmacy stock

What are the two ways controlled substances can be stored within the pharmacy?

1. Initial inventory is required on the 1st day of business

2. Inventory must be performed biennially with 6 months wiggle room

3.Any time a drug schedule changes

When specific times should controlled substance inventory be done?

•Schedule II: an exact count

•Schedule III-V: an estimate is allowed.....unless stock bottle holds more than 1,000 tab/caps

How should controlled substances be recorded during inventory?

•Name of controlled substance

•Dosage form and strength

•Number of units per container

•Quantity received

•Date of receipt

•Name/address/DEA number of the registrant from where the controlled substance was received

What must be included in the invoice used in the transfer of schedule III-V drugs?

A pharmacy would not to register with the DEA as a distributor as long as the total quantity of controlled substances distributed in a 12 month period does not exceed 5% of total quantity of controlled substances dispensed/distributed

When would a pharmacy not to be registered with the DEA as a distributor?

•Distributors authorized by the FDA for pharmacies to transfer controls back over to destroy

•Preferred method of destruction in a pharmacy

•DEA form 222 for schedule II

•Invoice for III-V

•DEA form 41 not required

•Exception, controlled substances dispensed to ultimate users or nursing homes

What are reverse distributors?

DEA form 41

Which form allows for disposal/destroying of controlled substance on site?

•DEA form 41

•Two witnesses

•Method of destruction must render all controlled substances "non-retrievable"

•Must consider EPA laws

What requirements must be met for disposal/destroying of controlled substances?

•Medical doctors

•Osteopathic physicians

•Dentists

•Podiatrists

•Veterinarians

•Optometrists (limited tramadol and Tylenol #3)

•PAs (limited to 7 days supply of schedule II)

•APRN (limited to 7 day supply of schedule II)

•Out of state practitioners

•Out of country practitioners WITH IS DEA REGISTRATION

Which professions have prescribing authority for controlled substances?

•Full name and address of patients

•Drug name, strength, and dosage form

•Quantity prescribed (Florida law requires numerically and textually)

•Directions for use

•# of refills authorized

•Name, address, and DEA number of practitioner

What are required components of controlled substance prescriptions?

•Electronically

•Written

•Verbally

•Facsimile or Fax

Which methods can controlled substances be transferred?

•FDA requries prescription to contain elements that are unable to be transmitted via eRX

•Patient receiving hospice care or is a resident of a nursing home facility

•It is in the patient's best interest to compare prescription drug prices among area pharmacies.... This reasoning must be documented in patient records

When is electronic transmission for controlled substances not indicated?

•Must be "manually" signed not stamped and dated on date issued

•Must be on counterfeit-proof pad approved by Fl DOH (resits copying, alteration, and tracking ID number)

•Cannot also include non-controlled medications on the same blank

What are requirements for written controlled substance scripts?

•Only schedule III-V can be verbally transmitted

•On Schedule III only maximum 30 day supply (Fl Law)

What are requirements for verbal transmission of controlled substances?

•Must be for "EMERGENCY" and intended for immediate administration

•No appropriate alternative treatment is available and prescribe r is unable to provide written prescription

•Quantity dispensed is limited to 72 hours supply (FL Law)

•Pharmacist must reduce all components ot writing (excluding practitioner signature

•A written/electronic prescription must be provided to pharmacist within 7 days, or else pharmacist must notify the DEA

Which schedule II can be transmitted verbally (exceptions to the rule)?

•Only schedule III-V

•Still must meet same requirements of a written prescription (manual signature)

What requirements must faxed transmission of controlled substances meet?

•Prescription for hospice patient

•Prescription for long term care facility patients

•Prescription for home infusion/IV pain therapy

What are the exceptions that allow a schedule II to be transmitted via fax?

1. Initiate communication with the patient to acquire relevant information

2. Initiate communication with the prescriber to acquire relevant information

3. In lieu of 1 or 2, but not both, the pharmacist may elect to access the PDMP to acquire relevant information

What are the minimum standards before refusing to fill a prescription?

•Within one business day of discovery.

•Florida Law reports it must be reported to the county sheriff within 24 hours of discovery

•Must be reported to the Florida Board of Pharmacy within one business day of discovery

•Complete DEA form 106

When must theft be reported to the DEA?

2 years

How long must controlled substance records be kept?

Corresponding Responsibility

The equivalent duty to ensure that a prescription is issued for a legitimate medical purpose and by an individual practitioner acting in the usual course of professional practice

•Required to be on the patient label of schedule II-IV substances

•Exception is participants in a blinded clinical study

When should this auxiliary label be used/

•Patients under 16 y/o

•Patients under hospice care

•Non-narcotics in schedule V (Lyrica, Vimpat, Brivact)

When do we not need to consult the PDMP?

•No greater than a 3 day supply can be prescribed/dispensed with documentation

What is the course of action if the PDMP cannot be accessed?

No later than close of the next business day

When is the latest a dispense of a controlled substance be reported to the PDMP?

•Acts of administration

•Dispensing within the healthcare system of department of corrections

•Dispensing to persons under 16 y/o

•Pharmacies/dispensing practitioners that do not dispense controlled substances in the state must submit 'Notification of exemption from reporting"

What are exceptions to reporting to the PDMP?

•Name of prescribing practitioner

•Practitioner's DEA number

•Practitioner's NPI number

•Date prescription was issued

•Date prescription was filled

•Method of payment

•Patient name/address/telephone number/DOB

•Controlled substance name, NDC, quantity, and strength

•Pharmacy name, DEA, address, and pharmacy permit number

•Whether prescription was initial fill or refill

•Name of individual picking up controlled substance and type of ID provided

What information must be reported to the PDMP by the pharmacy?

•Personally known by dispensing pharmacist

•Photo ID

•Verification of identity of the patient with the prescriber or prescriber agent

•Verification of health plan eligibility through real-time inquiry of adjudication system

•Any form of ID listed in 8CFR274a(b)(1)(v)(A) and (B)

What are acceptable forms of ID for receipt of controlled substances?