Controlled Substance State Laws

What does a CS license allow?

manufacturer, distribute, prescribe, and dispense CS

What is the CS license for a pharmacist like?

need one license to dispense from any pharmacy

What are exceptions to CS license?

agent/employee, carrier/warehouse employee, ultimate use/agent in possession

What must a distributor report?

distribution quarterly

What is the required training for a CS license?

one time only opioid/CS awareness, retention of 3 renewals + 1 year

When should the state be notified for theft/diversions?

within 15 days of investigation completion

What is considered significant loss?

qty of CS lost in relation to business type, specific CS lost, association with access by specific individual/unique activities, pattern of loss, likely candidate for diversion, local trends

What is the storage requirements for CS?

schedule 1 = locked, 2-5 = locked or dispersed throughout regular stock

What is the employee disqualification criteria?

licensee not employ with/without compensation an individual who is a substance abuser, CS license is expired/revoked/denied, convicted of crime related to CS and currently under sentence

When should CS inventory be done?

annually, < 30D before 5/1 but not > 60D after 5/1

What is the requirements for controlled schedules during inventory?

2 = actual count, 3-5 = estimate unless > 1000 need actual

When is inventory taken?

PIC change, new pharmacist, beginning or COB

How long are inventory records kept?

2 years

How long are invoices/acquisition records kept?

2 years, CII have separate file, III-V either separate or with others

What are the record requirements for CS prescriptions?

same as non-controlled = 5 years, 2 years can become electronic

What are requirements for written CS scripts?

qty written and numerical, preprinted box okay, animal = species/address and name of owner, legible, agent can prepare for prescriber to sign

What must be done by prescribers for CS scripts?

patient-prescriber relationship, MAPS, opioid counseling

What must be done by pharmacist when dispensing CS?

positive ID requirement if not known, transmitting agent name/receiving individual for oral rx, good faith criteria

What is the expiration of CS schedule II rx?

90 days

What are pharmacy/pharmacy monitoring/recording aspects with CS?

MAPS

What is the patient ID in MAPS?

full ane, address/zip code, DOB, any 1 of the following = DL, state ID card, passport, number zeroes for patient without other options

When can a pharmacist partially dispense a C2?

pharmacist unable to supply full qty, must give remainder within 72 hours, notify doc if not given in 72 hours

What is the requirements if a patient/prescriber request a C2 be partially filled?

remaining portions have to be filled within 30 days after date written

what is the expiration for partial dispensed C2 from long term care/terminal illness patients?

60 days after issue

What are the requirements with dispensing CV without a prescription?

240 ml opium liquid/48 hours, 120 ml guaifenesin or codeine/48 hours, keep record for 5 years

What are refills allowed for CII-V?

II = none, III-IV = 5 refills/6 months, V = up to 1 year

Who would be considered a distributor?

5% in 12 months

What is reverse distribution?

pharmacy send back to wholesaler, recall, destruction of expired/contaminated

What is done with discontinuation of business/transfers?

DEA 222 forms, return state license

What is used to order CS?

II = 222 form/CSOS, III-V = invoice/CSOS

centralized processing of CS

processing by a pharmacy of a request from another pharmacy to fill/refill a rx order or to perform processing functions such as dispensing, DUR, completing claims adjudication, obtaining refill authorizations, initiating therapeutic interventions, and other pharmacy functions