Disposal or Destruction of Controlled Substances page 59

Request DEA for permission to destroy - DEA will give 4 options
1. Two Parties - Keep records
2. State agency will destroy or forward to state agency
3. Hold for DEA
4. Forward to DEA

Part 1304 (page 162)

RECORDKEEPING (1304.03)

RECORDS OF DRUGS:
1.DISPERSED

2.RECEIVED
3.INVENTORIES
KEEP FOR TWO YEARS(1304.04)

Records of distributions to other dispensers

Same records as purchases from wholesalers

Records of Receipt

• 1. Schedule II drugs - Use third copy of DEA form 222.

• 2. Sch III, IV & V drugs. Invoices from wholesaler are acceptable. Invoices containing both controlled and non-controlled drugs must be identified in some notable manner.

Records of dispersal /Removal of any drugs from pharmacy

• 1. Prescriptions,
2. record books,
3. Form 222,
4. invoices,
5. med orders,
6. records of destruction & theft and loss

Prescription files - three options Section 1304.04(H) (page 163) or page 34

• 1. Three files:(This is the mandatory option for Ohio)
-Sch II
-Sch III, IV & V
-Non controlled drugs
2. Two files:
-Sch II
-Sch III, IV & V & non controlled drugs w controlled drugs marked w Red C

Prescription files

• 3. Two files:
All controlled drugs - III, IV & V with RED C
Non controlled drugs in separate file
Red C not required if computer can retrieve information

Filled Prescriptions - 1304.22(c)

• 1. Dated when written (issued)
2. Name & address of patient
3. Name & address & DEA # of practitioner
5. Date dispensed and number dispensed
6. Written or typewritten name or initials of dispenser
(Ohio requires written initials)

Inventory Requirement (1304.11)
(page 164)Page 34-35

1. All Controlled substances
2. Initial inventory then every two years
3. At beginning or end of business
4. Sch II exact count
5. Others estimate except for bottles >1000
6. Remember newly scheduled drugs When to inventory?

Records of Theft or Loss

Must notify DEA and State agency - Section 1301.76 (Use form 106)

1. Thefts must be reported to local law enforcement
2. Note Ohio board to be notified by phone immediately of any theft or significant loss of CS and dangerous drugs (4729-9-15)

1307.11 Five Percent Rule

• Note difference between DEA rule & Ohio Board of Pharmacy rule

• Pharmacies cannot distribute (different from dispensing) more than 5% of the total dosage units of all controlled substances they DISPENSE in one year.

Example

• Dispense total of 100,000 tablets of CS per year.

• Then the pharmacy cannot distribute more than 5000 tablets of CS to other pharmacies