📌 How to Use This Cheat Sheet
This is a rapid-review reference — not a substitute for understanding the law behind each item. Use it in your final week of preparation to confirm you have the key specifics memorized. For each item you cannot recall instantly, go back to your full study materials and review the context before re-testing on this list.
DEA Forms — Know Every One
| Form | Purpose | Who Uses It |
|---|---|---|
| DEA 106 | Report of Theft or Significant Loss | Registrant — must file within 1 business day of discovery |
| DEA 222 | Order Schedule I and II controlled substances | Purchaser completes; supplier keeps copies 1&2; purchaser keeps copy 3 for 2 years |
| DEA 224 | Application for retail pharmacy DEA registration | Pharmacies — renewal every 3 years |
| DEA 225 | Application for manufacturer/distributor/researcher registration | Non-retail DEA registrants |
| DEA 41 | Registrant Record of Controlled Substances Destroyed | Used when requesting DEA authorization to destroy controlled substances on-site |
| CSOS | Controlled Substances Ordering System — electronic equivalent of DEA 222 | Electronic ordering of CII; records kept 2 years |
Controlled Substance Schedule Rules
| Schedule | Refills | Rx Validity | Emergency Oral Rx? | Record Retention |
|---|---|---|---|---|
| CII | 0 — No refills ever | No federal expiration (most states add 6 months) | Yes — written Rx within 7 days | 2 years, stored separately |
| CIII | Up to 5 refills within 6 months | 6 months from issue date | Yes, at prescriber discretion | 2 years, readily retrievable |
| CIV | Up to 5 refills within 6 months | 6 months from issue date | Yes, at prescriber discretion | 2 years, readily retrievable |
| CV | Up to 5 refills (some OTC per state) | 6 months from issue date | Yes | 2 years |
CMEA Key Numbers (Pseudoephedrine)
- Daily limit: 3.6 grams of base PSE per person per day
- 30-day limit: 9 grams per person per 30-day period (7.5 g for mail-order)
- Storage: Behind counter or locked cabinet — never accessible to customers
- Logbook: Government ID required + signature; records kept 2 years
- Products covered: Any product containing PSE, ephedrine, or phenylpropanolamine
HIPAA Key Rules
- No authorization needed: Treatment, Payment, Operations (TPO) — the big three
- Minimum necessary: Applies to all disclosures except treatment and patient-requested
- Breach notification: 60 days from discovery; notify HHS; notify media if 500+ in one state
- Patient access request response: 30 days (one 30-day extension allowed)
- PHI retention: HIPAA requires retention for 6 years from creation or last use
- Psychotherapy notes: Always require specific authorization — even for TPO purposes
- 42 CFR Part 2: Stricter than HIPAA — governs substance abuse treatment records. Requires explicit written consent for most disclosures, even for treatment purposes.
PPPA — Child-Resistant Container Rules
- Who can waive CR: Patient (written or oral request documented) OR prescriber (on the prescription)
- Permanent exemptions (no CR required ever): Sublingual nitro tablets; oral contraceptives in manufacturer's package; powdered OTC aspirin; effervescent aspirin; inhalation aerosols; erythromycin ethylsuccinate granules
- LTCF exemption: Unit-dose medications for LTCF patients generally exempt
DQSA — 503A vs 503B
| 503A (Traditional) | 503B (Outsourcing Facility) | |
|---|---|---|
| Patient-specific Rx required? | Yes | No |
| Can sell in bulk to hospitals? | Limited | Yes |
| cGMP compliance required? | No | Yes |
| FDA inspects? | State boards primarily | Yes — FDA |
Drug Recall Classification
- Class I: Reasonable probability of serious adverse health consequences or death (most severe)
- Class II: May cause temporary adverse health consequences; probability of serious harm is remote
- Class III: Unlikely to cause adverse health consequences (least severe — labeling/packaging issues)
- Pharmacist duty: Remove recalled product immediately; notify affected patients; document all actions
Ryan Haight Act — Telemedicine CS Prescribing
- General rule: At least one in-person evaluation of the patient required before prescribing CS via telemedicine
- Exceptions: Emergencies; covering practitioners; Indian Health Service; PHE declarations by DEA; DEA-registered telemedicine sites
- Post-COVID: PHE flexibilities that expanded telemedicine CS prescribing are temporary — verify current DEA rules
DEA Inventory Requirements
- Initial inventory: Required when first registering
- Biennial inventory: Required every 2 years on any date within the 2-year window
- CII inventory: Exact count required always
- CIII–V inventory: Estimated count acceptable unless opened container has >1,000 units (then exact count)
- Retention: All inventory records kept for 2 years minimum