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Illinois Law

Controlled Substances Act

TermDefinition
Schedule 2 Rx All prescriptions shall have both a written and numerical notation of quantity, no refills may be given
Electronic Rx Requirements Overall, a prescription for a C2-5 substance must be sent electronically; unless they can certify with the board they will not write more than 150 prescriptions in a year. Before 1/26: financial hardship getting electronics, after requires waiver from CMS
Dispensing Controlled Substances Written prescription must be maintained on file for 2 years. Rx for C2 shall not be issued for more than a 30 d supply and shall be valid for up to 90 days. Rx for C3-5 shall not be (re)filled more than 6 months after issuance or >5 times w/o renewal
Labeling requirements Federal: Name/address of pharmacy, pt name, Rx #, date of dispensing, name of prescriber, directions, cautionary statements (if any) IL: Drug name, dosage, and quantity
Recordkeeping Requirements Federal and IL CSA - 2 years (all records) IL PPA - 5 years (all records) HIPAA - 7 years Medicare - 10 years (including invoices)
Security Requirements Effective controls and procedures top guard against theft/diversion of CS that are commensurate with the schedules and quantity should be put in place, no bags in CS areas, basic alarm system, maintain a physical key. All evidence available to division
Physical Security Controls Schedules 1 and 2must be stored in a securely locked, substantially constructed cabinet Schedule 3-5 shall be stored similarly or spread throughout the noncontrolled stock
Inventory Requirements Annual inventory should be conducted with actual count of C2s, and approximate counts of C3-5. Record of inventory should be kept for 5 years After theft/loss, DEA 106 should be sent to division within one business day after sent to DEA + sig of sender
C2 Partial Fills Is permissible if pharmacy is unable to supply full quantity. Must notate quantity supplied on Rx, and the rest must be picked up within 72 hours. After 72h, remaining can't be obtained without new Rx
Emergency Medication Kits No more than 10 controlled substances shall be placed in one kit, and no more than three single, injectable doses of each CS Consultant RPh shall check the CSs in the kit at least monthly and document inside the kit
Created by: skelly46
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