Texas MPJE: Chapter 2

Federal and Texas Controlled Substances Acts

Schedule 1 Drugs definition

high potential for abuse and severe potential for dependence

no currently accepted medical use in tx in US

C1 Drugs

• heroin

• dihydromorphine

• hallucinogens

  • marijuana

  • lysergic acid diethylamide (LSD)

  • peyote

  • mescaline

• depressants

  • methaqualone

Schedule II definition

high potential for abuse

have currently accepted medical use in tx in US or currently accepted medical use with severe restrictions

abuse of drug may lead to severe physical or psychological dependence

CII drugs

• opium

• narcotics

  • morphine

  • codeine

  • dihydrocodeine

  • oxycodone

  • APAP + hydrocodone (Vicodin)

  • methadone

  • meperidine

  • hydromorphone

  • fentanyl

  • cocaine

• stimulants

  • amphetamine

  • methamphetamine

  • phenmetrazine

  • methylphenidate

• depressants

  • pentobarbital

  • secobarbital

  • amobarbital

  • glutethimide

  • phencyclidine

narcotics definition

derivatives of opium, poppy straw, cocaine, ecgonine

while all narcotics are controlled substances, not all controlled substances are narcotics

schedule III definition

abuse of durg may lead to moderate or low physical dependence (addiction) or high psychological dependence (addition)

CIII drugs

• some narcotic CII drugs in combo with another ingredient (ASA/codeine, APAP/codeine Tylenol #3

• nonnarcotic

  • suppository forms of amobarbital, secobarbital, pentobarbital

• stimulants

  • chlorphentermine

  • phendimetrazine

  • benzphetamine

• anabolic steroids

  • testosterone

• ketamine and paregoric

• Fiorinal (butalbital, ASA, caffeine)

  • Fioricet (butalbital, APAP, caffeine) is exempt and NOT listed as controlled substance

Schedule CIV definition

abuse may lead to limited physical or psychological dependence

CIV drugs

• no more than 1mg of difenoxin

• no LESS than 25mcg of atropine sulfate PER dosage unit

• benzodiazepines

  • alprazolam

  • chlordiazepoxide

  • clonazepam

  • lorazepam

  • midazolam

  • oxazepam

  • triazolam

• depressants

  • chloral hydrate

  • phenobarbital

• stimulants

  • modafinil

  • phentermine

• others

  • fospropofol (Lusedra)

  • carisoprodol (Soma)

  • tramadol

  • pentazocine

  • butorphanol

schedule V definition

abuse of drug may lead to limited physical or psychological dependence relative to CIV

CV drugs

• pregabalin (Lyrica)

• ezogabine (Potiga)

• lacosamide (Vimpat)

• antitussive products containing codeine (Robitussin AC)

• antidiarrheal products containing opium, diphenoxylate (Lomotil) or difenoxin (Motofen)

  • concentration limits for diphenoxylate and difenoxin

  • ≤2.5 mg diphenoxylate and NOT LESS THAN 25mcg of atropine sulfate per dosage unit

  • ≤0.5 mg difenoxin and not less than 25mcg of atropine sulfate per dosage unit

examples of exempted prescription drug preps

Fiorcet

small amounts of phenobarbitals, butalbital, chlordiazepoxide, meprobamate

if the exempt status was removed, what would all butalbital containing products become?

C3

what are listed chemicals

in addition to legitimate uses, can be used in manufacturing a controlled substance

what otc products are considered listed chemicals

ephedrine*

pseudoephedrine

phenylpropanolamine*

*FDA removed from market for human use for safety reasons

is pseudeoephedrine considered a CS under federal law?

NO, but is subject to certain sales limitations and other restrictions

who has scheduling authority for CS on federal level?

U.S. Attorney General (head of Department of Justice) (DEA is under this)

• may add, delete or reschedule but must obtain scientific and medical recommendation from FDA

who has scheduling authority for CS on state level?

The Commissioner of the Texas Department of State Health Services

• may add, delete, or reschedule substance, but CANNOT override actions by legislature

what is the limit of compounding aqueous or oleaginous solutions or solid dosage forms

20% concentration

(>20% is considered manufacturing per DEA)

the narcotic substance must be compounded with:

one or more NONNARCOTIC therapeutic ingredients

codeine CV limit

200mg/100ml

codeine C3 limit

1.8g/100ml

AND

90mg/dosage unit

T/F: texas requires all codeine and dihydrocodeine products to be dispensed pursuant to a prescription

TRUE

Cheracol and Robitussin AC require prescription (C5)

if you add 1mg of codeine to Cheracol or Robitussin AC, what schedule is this?

C3 drugs

they already contain the MAX for C5

dihydrocodeine C5 and C3 limits

C5: 100mg/100ml

C3: 1.8g/100ml and 90mg/dosage unit

anything above = C2!!!

Opium federal and texas C5 limits

Federal CV 100mg/100ml

Texas CV 50mg/100ml

most of comercially available C5 products cannot be purchased without a prescription in Texas

these products are C3 under Texas law and require a prescription (higher than the texas limit)

Opium Schedule III limit

500mg/100ml

and

25mg/dosage unit

does morphine have a C5 compound?

NO, no morphine products are C5, either C3 or C2

C3 morphine limit

50mg/100ml

T/F: a compounded narcotic prescription will never be a C4

TRUE

what is required in Texas controlled substances by pharmacies?

ONLY registration with DEA

T/F: both pharmacies and practitioners register as dispensers

TRUE

not a separate registration form for prescribers

how often must DEA registrations must be renewed

every 3 years

Dispenser registrants start with letters (3)

A, B, F

Department of Defense: G

what is the second letter in DEA registration?

first letter of the practitioner’s last name for individual practitioners

first letter of pharmacy’s or hospital’s name

Mid-level practitioners include

NPs

PAs

ambulance services

animal shelters

veterinary euthanasia technicians

Mid-level designation first letter

M

separate registrations are required for different activities

TRUE

• C1 and C2-5 for research purposes are separate

steps to verify DEA registration

1. add 1st, 3rd, and 5th digits

2. add 2nd, 4th, 6th digits and multiply by 2

3. add sum of step 1 and step 2, last digit of number is last digit of DEA number

do pharmacies need to have separate DEA registrations?

YES

each pharmacy must have own registration

do individual practitioners who register at a single location but practice at others require separate registrations?

NO

• as long as they are only prescribing at other locations in same state

• if controlled substances are maintained at other locations or in diff state, must obtain separate registrations

DEA form 224

dispensers (pharmacies and practitioners)

DEA Form 225

manufacturers, distributors, researches, importers, exporters

DEA Form 363

narcotic treatment facilities

when are electronic reminders sent for DEA renewals?

60, 45, 30, 15, and 5 days prior to exp date

can registrant continue operations authorized beyond exp date if submitted in timley manner prior to expiration?

YES

what is max timeline for reinstatement after exp date of DEA?

1 calendar month after exp date

• if not, new DEA registration will be required

• federal law prohibits handling of controlled substances or List 1 chemicals for any period of time under expired registration

who is exempt from registering with DEA?

1. agent or employee of any registered mfg, distributor, dispenser (pharmacists, nurses)

2. common or contract carrier or employee thereof

3. ultimate user (patient) who possess for lawful purpose

4. officials of US Armed Services, Public Heath Service, Bureau of Prisions

for federal employees who are exempt, rules for e-prescribe and written RX

can issue electronic C2 prescriptions

canNOT issue written C2 prescriptions to be filled OFF base, out of facility

• would not be written on Texas official prescription form

• TSBP only issues to those who are registered with DEA practitioners

• when exemption from electronic rx applies for C3-5 from these feds, written prescriptions can be filled off base!

can practitioners use hospital DEA number?

YES

agents or employees of hospital may admin, dispense, prescribe CS under registration of hospital

what is the suffix at end of DEA # for hospitals?

internal code for each practitioner

• can be filled by ANY pharmacy, not just the hospital pharmacy

how long is previous owner DEA registration valid for if permitted?

45 days max

can temporary use of previous owner DEA registration be used?

YES

must agree:

• new owner must expedite applying for own registration

• previous owner grants Power of Attorney to new owner

  • PO allows CS activities to be under their DEA

  • PO agrees NO to order CS as agent of PO

  • PO acknowledges that they will be held accountable for any violations

  • PO agrees their DEA should remain in effect for no more than 45 days

when can a new owner apply for DEA registration?

has received state pharmacy license and state controlled substance license (if applicable, NOT IN TX)

DEA Form 222

each sale or transfer of Schedule II drugs

(can be used for Schedule I drugs for clinical/research trials)

how many items can be ordered on each numbered line of Form 222?

single item per numbered line

carfentanil, etorphine hydrochloride, diprenorphine orders

DEA Form 222; must only contain orders for those substances

super potent narcotics primarily used as animal tranquilizers

DEA Form 222 Rules

1. only single item may be ordered on each numbered line

2. orders for animal tranquilizers must only contain orders for those substances

3. number of lines completed must be noted on the form

4. name and address of supplier must be entered

5. must be signed by registrant AND by person being authorized to execute DEA form 222

6. registrant may authorize other individuals to execute form by creating POA

   1. does NOT need to be sent to DEA, just maintained in pharmacy

For DEA Form 222, the purchaser keeps what?

maintains copy of the form for its records and submits the original form to the supplier

copy in electronic or paper form (electronic copy does NOT need to be stored in different place)

who should report C2 transactions to DEA?

pharmacies who act as suppliers (<5% rule)

• <5% total distributions of all CS transactions during the year means they are suppliers

wholesalers DO NOT need to send a copy for DEA Form 222, ARCOS already tells the DEA

what must be done with product has been received for DEA Form 222?

purchaser must record the # of containers received

date received for EACH item on the COPY of the DEA Form 222

what specifically about Texas must be done on DEA Form 222 when product is received?

pharmacists must verify that CS listed on supplier’s invoice were actually received by recording on invoice their initials and actual date of receipt

what must be done if completed order form is lost or stolen?

purchaser must prepare another DEA Form 222

+

statement containing serial number and date of lost form: goods covered by the first order were not received because form was lost

how many days must a supplier supply the balance of an incomplete order from DEA Form 222?

60 days

is a CSOS certificate specific to a person or facility?

EACH person, not a facility

expires with the DEA registration of the facility (3 years)

which CSOS certificate is allowed for ordering controlled substances?

CSOS Signing Certificate - must have valid POA for CS ordering

• CSOS administrative certificate used for communications with DEA and with CSOS community

Who can obtain CSOS Signing Certificate?

A DEA registrant or an individual with Power of Attorney (POA) to order controlled substances.

Is Power of Attorney sent to DEA when using a paper DEA Form 222?

No. The POA must be maintained at the registrant's location but is not routinely sent to DEA.

When must a Power of Attorney be submitted to DEA?

When applying for a CSOS Signing Certificate (electronic Schedule II ordering).

DEA Form 222 vs CSOS: When is POA sent to DEA?

Paper DEA Form 222 → POA NOT sent to DEA.

CSOS Certificate → POA MUST be sent to DEA.

how long must statement of nonacceptance and original order statement be retained for CSOS?

2 years

• neither purchaser nor supplier may correct a defective order

how can C3-5 be ordered?

normal ordering processes from a wholesaler or manufacturer

must be documented by a pharmacy with an invoice provided by wholesaler/mfg

what must invoice contain when purchasing C3-5?

• name of controlled substance

• dosage form and strength

• number of units per container (100 tablet bottle)

• qty received (containers)

• date of receipt

• name, address, DEA number of registrant from where CS was received

what must be done for all invoices for controlled substances C3-5?

initialed by receiving pharmacist in Texas

which Classes do NOT need a pharmacist to sign invoice of C3-5? (2)

Class C-ASC

Class F

5% rule for Controlled Substances between registrants

pharmacy does NOT need to register with DEA as distributor if pharmacy does not exceed 5% of total qty of all CS dispensed and distributed during that same calendar year period

• CS returned to wholesaler are not included in count

what form is required for transfer of C2 drugs?

DEA Form 222

what form is required for C3-5 transferred drugs?

invoice provided by the supplier with all required elements

who initiates DEA Form 222?

person (purchaser) receiving the product INITIATES and fills out the form for C2 drugs, which is sent to the supplier or seller

who initiates invoice for C3-5 drugs?

invoice is provided by the SUPPLIER or seller to the purchaser

what system was implemented in 2019 for suspicious orders of controlled substances?

Suspicious Orders Report System (SORS)

• online centralized database

• only applies to distributions of controlled substances between DEA registrants, NOT dispensing of controlled substances by pharmacies

where can controlled substances be stored? (2)

1. secure cabinet that is locked

2. dispersal throughout the non-controlled stock to deter theft

3. may NOT store all CS on a single unsecured shelf

Texas law requires what CS to be stored differently?

schedule II controlled substances in Class C (Institutional) and Class F (Freestanding Emergency Medical Care Facility) must be stored in locked storage

when should theft or significant loss of CS be reported to DEA?

within 1 business day of discovery

DEA recommends notifying local police

when should theft or significant loss of CS be reported to TSBP?

immediately upon discovery

what form must be completed for Theft or Loss of CS?

DEA Form 106 online using DEA’s Theft and Loss Reporting (TLR) System

how many days should DEA Form 106 be inputted into DEA TLR system?

within 45 days of discovery of theft or significant loss

What should DEA Form 106 include

1. name and address of the registrant (pharmacy)

2. DEA registration #

3. Date of theft

4. name and telephone number of local police department notified

5. type of theft

6. total value (amt paid)

7. listing of CS missing from theft or significant loss

8. NDC number of missing products

9. listing of mail-back packages or inner liners lost or stolen (only appplies to pharmacies if they are Authorized Collectors of CS from ultimate users)

DEA Form 107

Loss of Listed Chemicals (pseudoephedrine)

when should form 107 be filed?

within 15 days after becoming aware of circumstances requiring the report

when should DEA be notified of lost of listed chemicals?

earliest practicable opportunity