Module 3: CS Handing and recordingkeeping

How does a pharmacy order CS II?

• form 222

• CSOS (controlled substance ordering system)

• used to transfer CII subs between any registrants

how long do we need to maintain form 222?

2 years!

what to do if you see suspicious orders?

• report to DEA through suspicious orders report systems (SORS)

• pharmacies must also report to the PEB on the same day as reporting to DEA!

T/F prescribers can write Rx’s for “office use” - including CS

FALSE

• they must prescribe for someone, not for office use

what are the limitations for a pharmacy as a CS distributor?

5 percent rule

• pharmacy can sell (distribute) no more than 5% of total dosage units dispensed annually to other DEA registrants

• if more than 5% = must register as a distributor

5% rule applies to what?

• total quantity of Rx drugs (CS + non-CS)

• also applies to all CS drugs as a subset

when is a pharmacy considered a CS distributor

when it sells CS to prescribers or to other pharmacies

when is CS inventory performed?

federally

• every 2 years

• initial registration

• buying/selling

• quarterly inspection

Schedule II

• perpetual inventory ( must have accurate inventory at ALL TIMES)

• reconciled at least quarterly

when is exact counts need for inventory?

• ALL CS II

• ALL containers of >1000 tabs/caps (for any schedule)

  • one containing exactly 1000 does NOT fall into this category!

recording keeping for CS: how to file, location, and duration

files

• CS II records separate from all other records

duration

• Rx/med profiles - 5 years

• DEA required records - 2 years

location

• registered location

  • invoices, shipping records can be kept at central location after notifying DEA

what does readily retrievable mean?

the standard for CS III-V records when field together with other records

• must have a visually marking that indicates its CS so that it is easy to find!

what to do when a pharmacy expereinces a significant loss

1. notify local police

2. notify local DEA office DIRECTLY via WRITTEN via 1 business dau

   1. also notify PEB

3. complete DEA form 106 and send to DEA office

Who should report a signficant loss if it was lost in transits?

• whoever has custody (supplier or purchaser) at time loss is discovered must report it