schedule changes:

when scheduling change occurs, a pharmacy must complete an inventory of the drug on the ___ the change become effective

date

dronabinol oral solution ( syndros) is classified as class ____ where as dronabinol capsule ( Marinol) is classified as scheduled ____

II

III

codeine single entity products are classififed as class ___ where as combination tablets/capsules that contain codeine are classified ____. Combination cough syrups with codeine are classified as class ____

II

III

V

Barbituate schedules refer to page 6

6

NMT: For a drug to be classified as schedule 3, opioid quantity should not have more than___

1.8 g of codeine per 100 mL or 90 mg per dosage unit ( when combined with an equal or greater quantity of an isoquinoline alkaloid of opium)

1.8 g of codeine per 100 mL or 90 mg ( when combined with one or more active non-narcotic ingredient)

1.8 g of dihydrocodeine per 100 mL or 90 mg per dosage unit

schedule IV: A drug is classified as class IV if NMT than

1 mg difenoxin and not less than 25 mcg of atropine per dosage unit

schedule V if NMT

200 mg of codeine per 100 mL or 100 g

100 mg of dihydrocodeine per 100 mL or 100 g

2.5 mg of diphenoxylate and not elss than 25 mcg of atropine per dosage unit

what are two natural compounds found in marijuana

THC and CBD

Federally, are pharmacies allowed to sell marijuana?

Pharmacies are not permitted to sell amrijuana or drug paraphernalia ( eg rolling papers)

calculation example on page 115

refer

Examples of schedule V medications are

these are codeine/promethazine, codeine/guaifenesin, codeine/promethazine/phenyephrine

Brivacetam

Cheratussin AC

Robutissun A-C

Virtussin A/C

Schedule IV drugs are

Benzodiazepines

Hypnotics

Weight loss drugs

Others: armodafinil etc refer to page 113

brand names and generics review skipped repeat

brand names and generic review skipped repeat

Controlled substances Section II

Section II

What are healthcare provider practices that can prescribe administer, or dispense controlled substances without registering with the DEA

Federal bureau of prisons

indian health service

US Armed forces ( Air Force, Army, Coast guard, Navy, Marine corps, Space force)

US Public health service

Ordering of controlled drugs for schedules 3-5 through CSOS, receipts of must be readily available in the pharmacy and should contain what?

name of each controlled substance

drug formulation

number of dosage units

numbe rof packages ordered and delivered

When ordering first control schedule I and II, the PIC must first register with the DEA form ____

222

CSOS can be used to oder I-V while dea 222 is limited to I-II. Note Schedule I have no medical use but may be ordered for investigational purposes

complete the following

DEA method of submission is ___ where as CSOS is ____

Limit of items in DEA form 222 ___ itms on triplate form, ___ on single sheet, ___ CSOS

Form 222 turn around time___, CSOS turn around time

DEA form 222 signature is ___ CSOS is

Can order be endorsed for Form 222? For CSOS?

Form 222 when does supplier report transaction to DEA?For CSOS?

Paper, electronic

10,20,no limit

2-5 days, 1-2 days

handwritten, digital

yes, no

by end of month, within 2 days

Triplate form ( copy 1,2,3) and no longer accepted after octoer 2021, we only use single sheet forms

each entity invloved in the transfer of schedule II must retain a copy for form 222

page 124

page 124

triplicate form 222 for scheduled II drug transactions

Pharmacy orders drug from a supplier copy 1(brown) goes to ___ copy 2 ( green) goes to ___ copy 3 ( blue) goes to___

Supplier, DEA, Pharmacy

triplicate form 222 for scheduled II drug transactions

Pharmacy returns unused drugs back to a supplier, copy 1 goes to ___ copy 2___ copy 3___

pharmacy

DEA

Supplier

triplicate form 222 for scheduled II drug transactions

Pharmacy sends unused drugs back to reverse distributor for disposal, copy 1 goes to __ copy 2__ copy 3___

pharmacy ( cause they are the supplier)

DEA

reverse distributor

triplicate form 222 for scheduled II drug transactions

Pharmacy sells or lends drugs to another pharmacy copy 1__ copy2__ copy 3___

supplying pharmacy

DEA

Receiving pharmacy

triplicate form 222 for scheduled II drug transactions

Pharmacy sells or lends drugs to a physician for administration or dispensing

copy 1___ copy 2____ copy 3____

pharmacy

DEA

Physician

The supplier must report the transaction to DEA within ___ business days from the date the order was filled

2

Lost or stolen DEA form 222

If a completed form 222 is lost or stolen,the pharmacy must provide a statement to the distributor with the new form 222. The pharmacy must provide a statement to the distributor with the new form 222 containing the following information:

serial number of original form

the date of the initial order

a statement that the controlled substances were not received

Distribution of controlled substances between dea registrants. An invoice or csos is used to transfer schedule III-IV drugs and must contain

drug name, dosage form, strenght, quantity

dtae of controlled substance transfer

recipient name address and dea number

If a pharmacy goes out of business All records of transfer should be kept for at least ____ years

2

initial and final inventory should bedone before the dispensing day has started or end of the day

Pharmacy can sell controlled substances to other pharmacies or prescribers registered with DEA to dispense controlled substances. The total quantity sold cannot exceed ____ % of the total quantity dispensed each year by the selling pharmacy

5%

cancelled or voiding controlled substances orders

the purchaser can cancel the order and notifying the supplier in writing

purchase must draw line and write _____ where as supplier must indicate _____ on form 222

cancell

cancellation

a supplier can void part or all of an order by notifying the purchaser.. Supplier must draw a line through the cancelled items on form 222 and print___ in the space for the number of items shipped

void

Loss or theft of controlled substances

Report theft within ___ business day of discovery. Submit form __ to DEA. If theft is determined not occurred the form doesn't need to be submitted

1

106

DEA Form ___ is used to document the destruction of controlled substances

41

even for breakage damage, spillage

if breakage or spillage is not recoverable, registrant must document the incident of inventory record, two witnesses to the breakage or spillage must sign the record

GA LAW: All controlled substances which are outdated or expired must be disposed of in a manner
that generates a DEA Form 41 (Drug Destruction Form), a copy of which must be
retained by the pharmacy. Such controlled substances can be disposed of by one of the
following:

(a) Representatives of the Georgia Drugs and Narcotics Agency (GDNA);
(b) Agents of the U.S. Drug Enforcement Administration (DEA); or
(c) A reverse distributor holding a current permit issued by the Georgia State Board of
Pharmacy (Board).

DEA Controlled substances inventory requirements

The registrant needs a record showing ___ inventory if there are no controlled substances at the time of opening. After initial inventory, a complete inventory of current stock on hand is taken minimally on a __ basisi

zero

biennial ( every two years)

how are records of inenvenotry of schedule II drugs kept?

separate from all other controlled substances

for sealed, unopened containers of all controlled substances an ____ count is needed

exact, there is no need to open a sealed container to perform a count

for opened containers fill the following

all scheduled I and II require ____ count

scheduled III , IV, V containers holding < 1000 dosage unit can be exact or estimated?

scheduled III , IV, V containers holding > 1000 can be exact or estimated?

exact

estimated

exact

record keeping of controlled substances

All scheduled II drug records must be kept separate from all other records. What about scheduled III, IV and V?

iii, iv, v must either be kept separately from all other records or stored in a way that the information is readily retrivable

Paper prescription record keeping: according to fedral law pharmacies have two options for filing paper

Option 1( three separate files): explain these

Option 2 ( two separate files) : explain these

option 1: 2S

345 S

Non controlled S

option 2:

2S

345 with red C at least 1 inch high + Non together but

letter c is waived if pharmacy has an electronic prescription recordkeeping system

federal law requires keeping records for ___ years

2

notify the DEA and borad of pharmacy in each state which intends to conduct business ___ days before dispensing through the inetrnet

30

Part III

PART III