U.S. Federal Pharmacy Law – Study Guide
This is your federal layer for the MPJE – CSA, DEA, FDA/FD&C, PPPA, HIPAA, OBRA ’90, Medicare/Medicaid, CMEA, Ryan Haight, REMS, and more.
Combine this with a state cheat sheet and always pick the stricter rule on exam day.
Use it as a printable one-pager, or scroll it on-screen with the toggles below.
Quick Navigation (Federal Clusters)
Fast mental model: “Federal = floor, State = ceiling.” Memorize the federal pattern in this guide, then write your state’s stricter numbers next to each section. On exam day, always choose the answer that matches the stricter rule.
Who Controls What? – The “F–D–C–H” Map
Think of federal pharmacy law as a set of “departments” you can route problems to: FDA handles drug quality & labeling, DEA handles controlled substances & diversion, CMS/OIG handles payment & fraud, and HHS/OCR handles privacy (HIPAA). PPPA (CPSC) lives in the safety/packaging lane.
What to Memorize From This Page
- Statute vs Regulation vs Guidance – U.S. Code vs C.F.R. vs manuals.
- FDA = FD&C Act, misbranding/adulteration, Rx vs OTC, REMS, compounding lanes.
- DEA = CSA, schedules, registration, ordering, records, disposal.
- CMS / OIG = Medicare/Medicaid payment rules and fraud/waste/abuse.
- CPSC (PPPA) = child-resistant packaging requirements.
- HHS / OCR (HIPAA) = PHI, privacy, security, breaches.
30-Second Story Version
- Congress passes big laws (FD&C, CSA, HIPAA, OBRA ’90).
- Agencies (FDA, DEA, CMS, CPSC, HHS/OCR) write detailed rules in the C.F.R. and guidance docs.
- States then add practice acts and board rules on top. On MPJE, the safest answer is usually “follow the stricter of state vs federal.”
Food & Drug Administration
- FD&C Act – safety, efficacy, labeling.
- Approves new drugs & biologics.
- Rx vs OTC status, REMS.
- Compounding lanes (503A/503B) & manufacturing quality.
Drug Enforcement Administration
- Controlled Substances Act (CSA).
- Schedules I–V, registration, ordering (222 / CSOS).
- Recordkeeping, prescribing/dispensing, disposal.
- Diversion control and investigations.
Medicare, Medicaid & Fraud Control
- Medicare Part D & Medicaid coverage rules.
- Billing standards and documentation expectations.
- Fraud, waste, abuse enforcement (e.g., Anti-Kickback).
- OIG compliance guidance for pharmacies.
Child-Resistant Packaging
- Poison Prevention Packaging Act (PPPA).
- Which Rx/OTC products require CR caps.
- Testing standards & packaging rules.
- Enforcement of packaging safety defects.
HIPAA Privacy & Security
- Defines PHI & covered entities.
- Privacy, Security, & Breach Notification Rules.
- Minimum necessary & patient rights.
- Investigates privacy complaints & breaches.
Medicaid DUR & Counseling
- Prospective & retrospective DUR.
- Offer to counsel Medicaid patients.
- Many states extend counseling to all patients.
Memory hook: Say out loud: “F–D–C–H + P” – FDA (drug quality & labeling), DEA (controlled substances), CMS/OIG (cash & claims), HHS/OCR (HIPAA privacy), PPPA/CPSC (child-resistant caps). Most federal MPJE questions can be solved by first asking: “Which letter is this?”
Schedules I–V – The Pattern You Actually Need
You do not need to memorize every drug, but you must know the ladder: abuse potential, accepted medical use, dependence risk, and the refill pattern. Once the ladder is memorized, most “What schedule is this?” or “How many refills?” questions become quick pattern matches.
Exam Checklist for Schedules
- C-I = no accepted medical use, highest abuse, no prescriptions.
- C-II = high abuse, accepted medical use, no refills.
- C-III & C-IV = “5 in 6” (5 refills within 6 months from date written).
- C-V = lowest abuse among controlled; refills as authorized under federal law.
- Federal vs state tension: marijuana/cannabis is C-I federally even if your state allows medical/recreational use.
One-Paragraph Pattern
The CSA schedules form a ladder from C-I (no medical use, highest abuse, no prescriptions) down to C-V (lowest abuse). C-II drugs have legitimate uses but severe abuse potential and can never be refilled. C-III and C-IV drugs are less risky and share the same refill rule – up to five refills in six months from the date written. C-V drugs are the least risky controlled substances and can be refilled as authorized by the prescriber under federal law. State law can tighten any step on this ladder but cannot loosen it.
Top of the Ladder – C-I vs C-II
Schedule I (C-I)
- High abuse potential.
- No accepted medical use.
- No valid prescriptions in community practice.
- Examples: heroin, LSD, MDMA; marijuana federally.
Schedule II (C-II)
- High abuse, but accepted medical use.
- Abuse → severe physical/psych dependence.
- Requires written/electronic Rx; no refills.
- Examples: morphine, oxycodone, hydromorphone, fentanyl, methylphenidate, amphetamines.
Middle & Bottom – C-III, C-IV, C-V
Schedule III (C-III)
- Less abuse than C-II, more than C-IV.
- Moderate/low physical or high psychological dependence.
- Refills: 5 in 6.
- Examples: products with limited codeine, buprenorphine, anabolic steroids, some dronabinol.
Schedule IV (C-IV)
- Abuse risk lower than C-III.
- Limited physical/psych dependence vs C-III.
- Refills: 5 in 6.
- Examples: benzodiazepines, Z-drugs, some weight-loss agents.
Schedule V (C-V)
- Lowest abuse potential among CS.
- Small amounts of certain narcotics.
- Refills: as authorized (no federal numeric cap).
- Examples: certain codeine cough syrups, some antidiarrheals.
| Schedule | Abuse / Medical Use | Refill Pattern (Federal) | Typical Examples |
|---|---|---|---|
| C-I | No accepted medical use; highest abuse. | None – cannot be prescribed. | Heroin, LSD, MDMA, marijuana (federal). |
| C-II | High abuse; accepted medical use. | 0 refills. | Strong opioids, stimulants, short-acting barbiturates. |
| C-III | Moderate abuse; moderate/low physical or high psych dependence. | 5 refills / 6 months. | Codeine combos, buprenorphine, anabolic steroids, some dronabinol. |
| C-IV | Lower abuse than C-III. | 5 refills / 6 months. | BZDs, Z-drugs, some weight-loss/sleep agents. |
| C-V | Lowest abuse among CS. | As authorized under federal law. | Certain cough syrups, antidiarrheals, low-dose combos. |
Schedule ladder to memorize: “I = No Rx, II = No Refills, III/IV = 5 in 6, V = As Written.” On any MPJE schedule question, run this ladder in your head first, then layer your state’s stricter rules on top.
Federal “Refill Ladder” – C-II, C-III/IV, C-V & Non-Controlled
MPJE loves to ask: “Is this prescription still valid?” and “Can it be refilled?”. This page gives you the federal ladder for controlled and non-controlled prescriptions. Your job: write your state’s stricter rule right next to each block.
Refill & Validity – What You Must Know Cold
- C-II – no refills, ever, under federal law.
- C-III & C-IV – max 5 refills within 6 months from the date written (“5 in 6”).
- C-V – may be refilled as authorized by the prescriber (no federal numeric cap).
- Non-controlled – federal law does not set a fixed “expires in X months” rule; this is usually from state law and payers.
- On test day, whenever you see a refill/expiration question, first apply the federal ladder, then overlay your state’s stricter limits.
Refill Ladder (Federal)
- 1 C-II → 0 refills
- 2 C-III & C-IV → 5 refills / 6 months
- 3 C-V → as authorized by prescriber (no federal number)
- 4 Non-controlled → expiration & refills driven by state & payers
Write your state’s stricter numbers next to each step in this ladder.
Trap – “Expired” vs “No Refills Left”
MPJE mixes up refill limits and time validity. For C-III/C-IV, both matter (“5 in 6”). For C-V and non-controlled prescriptions, federal law does not set a numeric expiration. When you see a scenario, say out loud: “Is this about number of refills, time since written, or both?” then apply the ladder above.
Memory hook: “II = 0, III/IV = 5-in-6, V = as written, Non-CS = state decides.” Write this once at the top of your scratch paper on test day and reuse it on every refill/validity item.
C-II Partials & Emergencies – 5 Scenarios to Memorize
C-II prescriptions can never be refilled, but they can be partially filled in specific situations, and there’s a special rule for emergency oral C-II prescriptions. MPJE questions love to mix these together. This page breaks it into 5 named scenarios you can recall quickly.
The 5 C-II Scenarios
- Pharmacy out-of-stock (“unable to supply” partial).
- LTC / terminally ill patient – multiple partials allowed.
- CARA patient/prescriber-requested partial – patient wants less now.
- Emergency oral C-II – true emergency, phone-in C-II.
- Multiple C-II Rxs up to 90 days – future-dated “do not fill before” set.
On test day, label which scenario you’re in first, then recall the box below.
- Reason must be pharmacy stock – not patient preference.
- Document quantity dispensed and remaining amount on the Rx or in the electronic record.
- Remaining quantity must be dispensed within the allowed time frame or not at all.
- Pharmacist must mark the Rx as “LTCF patient” or “terminally ill”.
- Each partial fill requires recording date, quantity dispensed, remaining amount, and pharmacist ID.
- Total dispensed quantity cannot exceed the original prescribed amount.
- Here, the driver is clinical preference or patient request, not pharmacy stock shortage.
- Pharmacist must track cumulative quantity and ensure remaining amount is dispensed within the permitted time period or not at all.
- States may narrow or condition the use of these federal flexibilities.
- Situation must require immediate administration, with no suitable alternative and no time to provide written/electronic Rx first.
- Quantity is limited to the amount needed for the emergency period only.
- Prescriber must provide a follow-up written or DEA-compliant electronic prescription within a short federally-defined time (classically referenced as about 7 days), clearly referencing the emergency dispensing.
- If follow-up is not received, the pharmacist documents and notifies DEA per requirements.
- Prescriber must judge that this does not create an undue risk of diversion or abuse.
- Each prescription is a separate, valid Rx with its own date and all required elements.
- Later prescriptions must include instructions such as “Do not fill before [date].”
- Total quantity of all C-II prescriptions issued that day must not exceed a 90-day supply.
- States or payers may restrict or discourage this practice even though it is permitted federally.
Trap – Partial vs Refill vs Emergency
A partial fill is not a refill. C-II prescriptions can be partially filled in specific scenarios but can never have refills. Emergency oral C-II prescriptions are a separate, narrow pathway with their own rules. On MPJE, write “1: Stock, 2: LTC/Terminal, 3: CARA, 4: Emergency oral, 5: 90-day multiple” on your scratch sheet and match the question to the scenario before answering.
Memory hook: Say: “Stock, LTC, CARA, Emergency, Ninety.” That’s your 5-box C-II map. If a question doesn’t fit one of those boxes, pause – you’re probably missing something in the scenario.
Who Needs a DEA Number? – Registration Types & Responsibilities
Before you can prescribe, dispense, or handle controlled substances, you need the right type of DEA registration at the right location. This page turns the DEA registration world into a small set of flash cards: who registers, what form they use, and what they’re allowed to do.
What to Be Able to Answer in 10 Seconds
- Which activities require DEA registration: manufacture, distribution, dispensing, research, OTPs.
- When a separate location does or does not need its own DEA number.
- Role of DEA Form 224 / 224a for pharmacies and practitioners.
- Difference between an individual DEA and an institutional (hospital) registration.
- Basic responsibilities of every registrant: security, recordkeeping, reporting theft/loss, and not accepting suspicious orders.
DEA Registration Roles (Big Picture)
- Manufacturers – make controlled substances.
- Distributors / Wholesalers – move product between registrants.
- Dispensers – pharmacies & prescribers that give drug to patients.
- Narcotic Treatment Programs (OTPs) – methadone/buprenorphine for OUD.
- Researchers – conduct studies on controlled substances.
On MPJE, most questions occur in the “dispenser” lane (community, hospital, clinic pharmacies and prescribers).
Makes Controlled Substances
- Produces bulk or finished dosage forms.
- Needs manufacturer-level DEA registration.
- Heavy security, recordkeeping, and quota controls.
Moves Product Between Registrants
- Ships controlled substances to pharmacies, hospitals, prescribers.
- Must monitor for suspicious orders and report them.
- Uses DEA Form 222/CSOS for C-II distribution.
Pharmacies & Prescribers
- Includes community & hospital pharmacies.
- Includes prescribers who administer or dispense CS in practice.
- Register using DEA Form 224 / renew with 224a.
Opioid Treatment Programs
- Dispense methadone or other meds for OUD treatment.
- Need special OTP registration & certification.
- Heavily regulated dosing, take-home rules, and records.
Study & Lab Use
- Researchers studying controlled substances.
- May have schedule-specific research registrations.
- Tight accountability for every milligram used.
Hospital DEA vs Prescriber DEA
- Hospitals can have an institutional DEA.
- Interns/residents may prescribe under hospital DEA + internal code.
- Independent prescribers usually maintain their own DEA number.
- A chain pharmacy with 10 stores usually needs 10 pharmacy DEA registrations.
- A hospital with satellite “departments” may or may not need separate registrations depending on how operations are structured and where drugs are stored.
- Temporary off-site vaccination or health fair clinics are often governed by state-specific rules; federal DEA may not require a separate registration if they operate as an extension of a registered site and do not store CS long-term.
Think “2-2-4 = To-Dispense-For”. If your job is to dispense for patients, you are probably in the 224 group.
Trap – “We Use the Doctor’s DEA for the Whole Pharmacy”
A pharmacy generally needs its own DEA registration as a dispenser. It is not correct for the entire pharmacy to “borrow” an individual prescriber’s DEA for all ordering and dispensing. Individual prescriber DEA numbers are for that prescriber’s ordering/prescribing authority; the pharmacy, as a facility, has its own registration and responsibilities.
Memory hook: On your scratch paper write: “M–D–D–O–R” = Manufacturer, Distributor, Dispenser, OTP, Researcher. Any DEA registration question fits into one of those buckets.
DEA Number Logic & “Corresponding Responsibility”
MPJE questions love the DEA number. But instead of memorizing the checksum formula in pain, focus on the pattern: what each letter prefix means, how institutional DEA numbers work, and the pharmacist’s corresponding responsibility to refuse obviously invalid prescriptions.
High-Yield DEA Number Concepts
- DEA number = 2 letters + 7 digits (with a check digit concept).
- First letter shows registration type (e.g., A/B/F/G for most practitioners/facilities, M often for mid-levels).
- Second letter usually matches the first letter of prescriber’s last name (or institution name).
- Institutional DEA: prescribers use the hospital’s DEA plus a unique internal code.
- Corresponding responsibility: pharmacists must refuse prescriptions that are not issued for a legitimate medical purpose.
Big Idea in One Sentence
The DEA number is an identifier that signals “this prescriber or facility is registered for controlled substances,” but a valid DEA number alone does not guarantee a prescription is legal – the pharmacist has a corresponding responsibility to catch and refuse obvious red-flag prescriptions.
Prefix Cheat Sheet (High-Level)
- A / B / F / G – physicians, pharmacies, hospitals, clinics, main practitioners.
- M – mid-level practitioners (e.g., NPs, PAs) where applicable.
- X – historically used for DATA-waived buprenorphine prescribers (now phased out; current rules focus on regular DEA numbers with scope of practice).
On MPJE, they may show older-style X numbers but emphasize that prescribing authority must still match state scope of practice and DEA registration.
Structure & Name Match
- Format: Letter 1 (type) + Letter 2 (name) + 7 digits.
- Second letter usually matches the first letter of the prescriber’s last name (or institution).
- The last digit is a check digit that can be validated with a math formula, but MPJE rarely asks you to perform the full calculation.
For the exam, you mainly need to recognize an obviously bogus DEA (wrong prefix or name mismatch) and know that “correct format” alone does not make a prescription legitimate.
- Clearly inappropriate dose or combination (e.g., high-dose opioid + BZD + carisoprodol for multiple unrelated patients).
- Prescriber writing outside their usual specialty or geographic area in suspicious patterns.
- Patients traveling in groups, paying cash, seeking early refills without explanation.
- Pharmacy dispensing large volumes of high-risk regimens without documentation or resolution of concerns.
- Institutional DEA is not the same as giving every prescriber their own DEA number through the hospital.
- Prescriptions must contain the institution’s DEA plus the prescriber’s assigned code and signature.
- Scope of practice and state licensure still limit what each individual may prescribe.
Trap – “DEA Number Looks Okay, So It Must Be Fine”
A prescription can have a DEA number that looks valid and still be illegal or inappropriate to dispense. The MPJE will test whether you remember that the pharmacist has an active corresponding responsibility to question and refuse prescriptions that show obvious signs of abuse, diversion, or non-therapeutic intent – even if the math on the DEA number checks out.
Memory hook: Say: “DEA ≠ autopilot.” First, glance at the prefix & name to see if it makes sense. Second, ask: “Does this prescription make clinical sense?” If either answer is no, your corresponding responsibility is to stop and clarify before dispensing.
DEA Forms, 222s & CSOS – The “Form Deck” You Must Know
Federal controlled substance work is basically a card game of forms. MPJE questions often ask: “Which form is needed here?” or “How long do you keep the records?” This section turns the main DEA forms into a compact flash deck: what each form is for, who uses it, and what happens if something goes wrong.
Forms You Need to Recognize Instantly
- DEA Form 222 – paper ordering of Schedule II drugs.
- CSOS (electronic 222) – electronic ordering of C-II, with added flexibility.
- DEA Form 106 – report significant theft or loss of controlled substances.
- DEA Form 41 – document destruction of controlled substances.
- DEA Form 224 / 224a – registration and renewal for dispensers (pharmacies/practitioners).
One-Line Memory Hooks
- 222 → “Two-Two-Two = To-Order C-II.”
- 106 → “One-Oh-Six = Oh No, Theft.”
- 41 → “Four-One = For Destruction.”
- 224 → “To-Dispense-For = Registration.”
- CSOS = “Online 222 with more flexibility and less paper.”
On test day, if you can match the scenario to the right “form hook,” most questions here are freebies.
Paper C-II Order Form
- Used to order Schedule II controlled substances.
- Also used to transfer C-II drugs between registrants.
- Requires careful completion, signature, and record retention.
Electronic C-II Ordering
- “Controlled Substance Ordering System.”
- Allows electronic ordering of C-II (and sometimes other schedules).
- Can support larger orders and more lines than paper 222s.
Theft or Significant Loss
- Used to formally report significant theft or loss of controlled substances.
- Filed after internal investigation/verification of loss.
- Often submitted electronically via DEA systems.
Destruction of Controlled Substances
- Documents the destruction of controlled substances.
- Used for expired, damaged, or unusable inventory when destroyed.
- Can involve reverse distributors or authorized destruction processes.
Registration & Renewal – Dispensers
- 224: application for initial registration as a dispenser (e.g., pharmacy).
- 224a: renewal for existing dispenser registrations.
- Must be renewed periodically to keep DEA status active.
- MPJE may ask which transactions require a 222/CSOS order (e.g., wholesaler → pharmacy, pharmacy → pharmacy transfer of C-II).
- Refills and dispensing to patients do not use Form 222; that form is for registrant-to-registrant transfers.
- “Significant” is a professional judgment call, based on quantity, pattern, type of drug, and local context.
- Registrants should investigate and document facts before filing the final report.
- State boards and local authorities may require parallel reports.
- Pharmacies may send controlled substances to a registered reverse distributor for destruction.
- Alternatively, destruction may be conducted on-site under defined procedures with documentation.
- Drug take-back events and consumer returns have additional guidance; the key principle is a secure chain and documented destruction.
Trap – Mixing up 106 vs 41 vs 222
MPJE loves “form swap” questions. If the scenario is about ordering C-II, think 222/CSOS. If it’s about theft or loss, think 106. If it’s about destruction, think 41. If it’s about getting or renewing DEA registration, think 224/224a. Once you attach the right verb – order, lose, destroy, register – the form usually falls into place.
Memory hook: Write this mini-equation: “222/CSOS = ORDER, 106 = LOST, 41 = GONE, 224 = EXIST.” Every DEA form question you see on MPJE will line up with one of those verbs.
CS Inventory, Counting Rules & “Readily Retrievable” Records
When DEA visits, they live in your records: inventories, invoices, 222s/CSOS, prescriptions, and logs. This page summarizes federal expectations for initial and periodic inventories, how to count C-II vs C-III–V, and what “readily retrievable” really means.
Inventory Facts to Know
- Need an initial inventory of all controlled substances on hand when first engaging in dispensing.
- Need a periodic inventory at least every two years (biennial) under federal law.
- C-II substances must be counted with an exact count.
- C-III–V can often be estimated unless the container is above a certain large size, where an exact count is required.
- Records must be kept separate or readily retrievable, and retained for at least a minimum period under federal law.
Bird’s-Eye View
Federal law wants a clear, current picture of exactly what controlled substances you have on hand and where they came from. You start with an initial inventory, update with every shipment and dispensing event, and perform at least a biennial inventory. C-II counts must always be exact. C-III–V counts can often be estimated unless in large containers, but many pharmacies choose exact counts anyway. Records must be organized so that DEA can quickly separate and review controlled vs non-controlled files.
Starting Snapshot
- Taken on the day the pharmacy first stocks controlled substances.
- Lists all controlled substances “on hand.”
- Includes drug name, strength, dosage form, and quantity.
At Least Every 2 Years
- Required at least every 2 years under federal law.
- Can be done more frequently if the pharmacy chooses.
- Must clearly indicate whether it was taken at opening or close of business.
Exact vs Estimate
- C-II: must always be counted exactly.
- C-III–V: may be estimated unless the stock bottle is very large (beyond a specified high-count threshold), where an exact count is required.
- Many pharmacies prefer exact counts for all controls for simplicity.
- Separate physical files for C-II, C-III–V, and non-controlled prescriptions.
- Single file with controlled prescriptions stamped or highlighted and easily searchable in the system.
- Electronic systems that can produce controlled-only reports quickly on request.
The exam often asks about the minimum federal standard, then adds that state law might extend the period. When unsure, remember that keeping records longer than required is never a violation; keeping them for too short a time is.
On MPJE, if the question shows an inventory without a date, or without clarity on whether it was taken at opening/close of business, that is a red flag. Real-world inventories also often include location notes and running page totals to reduce errors.
Trap – “We’ll Just Estimate Everything”
Federal law expects exact C-II counts and allows some estimation for C-III–V in smaller containers, but that does not mean sloppy counting is okay. On MPJE, if you see a pharmacy “estimating” C-II inventory or discarding records before the minimum retention period, assume that’s incorrect under federal rules.
Memory hook: Write: “I-B-C-R” on your notes – Initial, Biennial, Count rules (C-II exact, III–V estimate/large exact), Readily retrievable records. Every DEA inventory/recordkeeping question will touch at least one of those four pieces.
CS Storage & Security – Safes, Dispersion & Access Control
Federal law requires registrants to provide effective controls and procedures to guard against theft and diversion of controlled substances. This section turns the general “security” requirement into a checklist: where you keep drugs, who has keys, how you organize shelves, and what makes DEA nervous on an inspection.
Security Concepts to Know Cold
- Pharmacies must maintain effective controls against theft & diversion.
- Options include secure storage (e.g., locked safe/cabinet) and dispersion of controlled stock among non-controls.
- High-risk settings (e.g., large quantities, high crime area) usually need stricter physical security.
- Access to controlled substances must be limited and supervised.
- Losses, thefts, and suspicious activity trigger reporting duties and sometimes security upgrades.
Big Picture
DEA does not prescribe one “perfect” storage layout; instead it expects you to match the level of security to your risk. Small, low-volume pharmacies in safe areas might rely on locked cabinets plus dispersion of stock. High-volume sites handling large quantities, or those with a history of diversion or local crime, should have safes, alarms, cameras, and tighter access controls. On MPJE, whenever you see a risky situation, assume that more security is required, not less.
Safes, Vaults & Cabinets
- Controlled substances may be stored in a locked safe, cabinet, or vault.
- Heavier, bolted safes provide better protection for C-II stock.
- Keys/combinations should be limited to authorized staff only.
Mixing Controls with Non-Controls
- Controlled substances may be dispersed among non-controlled stock.
- Makes “smash-and-grab” theft less efficient.
- Still requires restricted access areas (e.g., pharmacy department, secure storerooms).
Who Can Get to the Drugs?
- Only authorized personnel should enter CS storage areas.
- Use badges, keys, codes, or logs as appropriate.
- Monitor access patterns and investigate irregularities.
- If the exam describes large quantities of high-risk C-II drugs with minimal security, assume that is insufficient under federal law.
- Security expectations are higher in areas with known diversion or crime problems.
- Failure to upgrade security after documented thefts can be seen as non-compliance.
- Conduct reasonable background checks consistent with state and federal rules.
- Restrict CS access for employees with relevant red flags.
- Use double-checks or witnessed counts for high-risk activities (e.g., closing shift CS counts).
Trap – “We Keep All the C-II in an Unlocked Drawer”
On MPJE, an unsecured drawer of C-II medications in a busy, high-traffic area is almost never acceptable. If you see words like “unlocked,” “public hallway,” “open access,” or “no cameras” paired with high-risk controlled substances, assume that federal expectations for effective controls are not being met.
Memory hook: Think “S-A-F-E” – Storage (locked/secure), Access (limited), Footprint (risk-adjusted security for volume & location), Employees (screened & supervised). That’s the core of federal CS security.
Federal Rules for Prescriptions – “Legitimate Purpose” & Required Elements
Every MPJE exam will test the core federal rule: a controlled substance prescription must be issued for a legitimate medical purpose by a prescriber acting in the usual course of professional practice. This section walks through that standard, plus the required elements of a prescription and how oral/fax rules fit in.
Key Concepts for Prescriptions
- Controlled prescriptions must be for a legitimate medical purpose by a prescriber acting in the usual course of practice.
- The pharmacist has a corresponding responsibility not to knowingly dispense illegitimate prescriptions.
- All prescriptions must contain core elements: patient, prescriber, drug, directions, and signature.
- Federal law allows certain controlled prescriptions to be oral or faxed in specific circumstances, but C-II is the most restricted.
- State law often adds stricter format, ID, or documentation requirements.
One-Sentence Core Rule
A controlled substance prescription is only valid if it is issued by a properly authorized prescriber for a legitimate medical purpose in the usual course of professional practice, and the pharmacist shares responsibility for refusing or resolving any prescription that fails that standard.
Required Elements – Big Picture
- Patient – full name and sufficient identifying info (e.g. address).
- Date the prescription was issued.
- Drug – name, strength, dosage form, quantity.
- Directions for use (sig) and number of refills, if any.
- Prescriber – name, address, DEA (if CS), and signature.
State law may require additional elements (e.g., diagnosis codes, IDs, or specific warnings), but those are layered on top of the federal baseline.
Format – Written, Oral, Fax, Electronic
- Non-controlled prescriptions may be written, oral, faxed, or electronic, subject to state rules.
- C-II generally requires a written or DEA-compliant electronic prescription, with limited exceptions for fax or oral in special cases (e.g., certain LTC/hospice scenarios, emergency oral C-II).
- C-III–V may generally be written, oral, faxed, or electronic under federal rules, with state overlays.
On MPJE, identify the schedule first, then ask which formats are allowed for that schedule under federal law, and finally overlay stricter state-specific rules.
- Prescriber writing controlled prescriptions to themselves or family solely to maintain personal supply.
- “Prescriptions” written to cover diversion of office stock or to support illicit sale.
- Prescribing large, unjustified quantities of high-risk combinations without documentation.
Questions often ask whether a pharmacist must fill a prescription that “looks legal” on paper but is clinically suspicious. Under the federal standard, the pharmacist is expected to pause, clarify, and refuse if concerns are not resolved.
- If the question describes a routine outpatient C-II fax or oral prescription with no exception (e.g., not LTC/hospice, not emergency), be skeptical under federal rules.
- For C-III–V, assume greater flexibility with oral and fax, unless your state says otherwise.
- Always identify the schedule before judging whether the transmission method is allowed.
Trap – “It Has a Signature, So I Have to Fill It”
A signature and a DEA number do not force the pharmacist to dispense. Under federal law, if the pharmacist believes the prescription is not for a legitimate medical purpose, they must refuse to fill it and take appropriate steps (contact prescriber, document, possibly report). On MPJE, answers that imply the pharmacist has “no choice but to fill” a clearly suspect prescription are usually wrong.
Memory hook: Write: “P-P-P-S” – Patient info, Prescriber info, Product & directions, Signature. Then circle “LMU” for Legitimate Medical Purpose and Usual course of practice. If any of those pieces fail, the prescription is not valid under the federal standard.
Moving Controlled Substances – Transfers, Returns & Emergency Kits (Federal Pattern)
At some point, controlled substances will move between pharmacies, back to suppliers, or into emergency kits for facilities. This section gives you the federal pattern: when a transaction is a dispense vs a transfer vs a destruction/return, and how that shows up on MPJE.
What to Recognize in Transfer Questions
- Difference between dispensing to a patient vs transferring to another registrant.
- How pharmacies transfer C-II vs C-III–V drugs to each other.
- Concept that repeated large transfers can turn a pharmacy into a distributor under federal rules.
- High-level idea of returning stock to a reverse distributor.
- Emergency kits and floor stock in facilities are handled under the facility’s registration and policies.
Mental Model
Any time controlled substances move, ask: “Is this to a patient, or to another registrant?”. Patient fills follow the usual prescribing/dispensing rules. Transfers between registrants follow ordering/record rules (Form 222/CSOS for C-II, invoices for C-III–V), and large or frequent transfers can require a distributor-level registration.
To the End-User
- Prescription from prescriber → dispensed to individual patient.
- Recorded as a dispense, not a transfer.
- Governed mainly by prescribing/dispensing rules (Sections 3–4 & 10).
Transfers Between Registrants
- Pharmacy ↔ pharmacy, or pharmacy ↔ provider, etc.
- Requires proper order/transfer documentation.
- Pattern: 222/CSOS for C-II, invoice for C-III–V.
Reverse, Returns & Emergency Stock
- Returns/destruction via reverse distributors or other procedures.
- Emergency kits & floor stock used under facility protocols.
- Still controlled by the registrant’s records and security rules.
- This is not a “dispense to patient.” It is a registrant-to-registrant transfer.
- The transferring pharmacy records the drug as leaving inventory; the receiving pharmacy records it as received C-II stock.
Think: “222 = C-II, Invoice = III–V.” Any exam question that shows C-III–V transfer between registrants being done with a 222 form is suspicious.
On MPJE, if a pharmacy is frequently supplying large amounts of controlled substances to other pharmacies or prescribers, the safer answer is that DEA may view this as distribution rather than occasional transfers, with higher registration and recordkeeping expectations.
- C-II returns to a reverse distributor typically use a DEA Form 222/CSOS or equivalent ordering process.
- C-III–V returns use invoices or similar records of the transfer.
- The reverse distributor handles or documents the actual destruction (e.g., via Form 41 or equivalent), keeping a clear audit trail.
Exam questions may describe a facility “loaning” emergency C-II doses to nearby sites or leaving crash carts unsecured in public hallways. Apply the same principles: proper registration, secure storage, documentation of removal/administration, and compliant transfer procedures if they move between registrants.
Trap – “Just Ring It Up As a Patient Rx”
When a pharmacy moves controlled substances to another pharmacy or prescriber, that is not a patient prescription and should not be disguised as one. On MPJE, any “solution” that treats an inter-registrant transfer as if it were a normal patient fill to avoid DEA paperwork is usually incorrect under federal law.
Memory hook: Say: “P-T-R-K” – Patient dispensing, Transfers between registrants, Returns/reverse distributors, Kits & floor stock. Any movement question on the exam fits into one of those four buckets.
Hospital, Clinic & LTC CS Rules – Orders, Floor Stock & ADCs
Hospitals and long-term care facilities don’t use “retail-style” prescriptions for every dose. Instead, they work with medication orders, floor stock, and automation like ADCs. This section gives you the federal pattern for how controlled substances are handled inside institutions, without diving into any one state’s extra rules.
Institutional Concepts to Recognize
- Use of an institutional DEA with individual prescribers acting under it.
- Difference between a medication order in an inpatient chart and an outpatient prescription.
- Controlled substances kept as floor stock or in ADCs still belong to the registrant’s inventory.
- Additional documentation for wasting partial doses (e.g., injectable C-II).
- Emergency kits and after-hours access must still follow security and recordkeeping expectations.
Big-Picture Story
In institutional practice, controlled substances are ordered to a specific patient or kept as limited stock for emergent use, but they always remain tied to the facility’s registration and records. Nurses may administer doses based on prescriber orders, but pharmacists and the institution are still responsible for secure storage, accurate counts, and documentation.
Inpatient Orders & MAR
- Written or electronic orders in a patient’s chart.
- Pharmacy verifies, profiles, and dispenses as appropriate.
- Administration documented on MAR/eMAR with time, dose, and initials.
Decentralized Storage
- Selected controlled meds stored in secure cabinets or ADCs on nursing units.
- Access restricted to authorized staff with user IDs and audit trails.
- Periodic reconciliation of ADC counts vs inventory records.
Documenting Discarded Amounts
- Common for injectable C-II doses (e.g., opening a 10 mg vial, giving 4 mg, wasting 6 mg).
- Facilities use witness signatures or electronic attestations for waste.
- Wasting must be captured in records to keep controlled counts accurate.
- Orders for inpatients are not “office stock prescriptions”; they are tied to specific patients.
- The institution’s DEA and policies govern how orders are written, verified, and filled.
- Scope-of-practice limits still apply to each individual prescriber.
- Nurses accessing an after-hours cabinet document each removal with patient, drug, dose, and time.
- The pharmacy later reconciles removals against orders and inventory.
- Unaccounted-for doses or repeated discrepancies can indicate diversion and trigger investigation and reporting.
Trap – “It’s a Hospital, So DEA Doesn’t Care”
Hospitals and LTC facilities are under the same federal controlled substance laws as retail pharmacies. If a scenario shows unsecured crash carts, uncontrolled ADC overrides, no documentation of waste, or no reconciliation of floor stock, assume that federal expectations for security and recordkeeping are not being met, even if state law details are not mentioned.
Memory hook: For institutional CS, think “O-F-W-A” – Orders (chart-based), Floor stock/ADCs, Wasting documentation, After-hours cabinets. Any hospital/LTC MPJE question about controlled substances will lean on at least one of these four pillars.
Who Can Prescribe Controlled Substances? – Federal Definition & Mid-Level Pattern
Federal law uses the term “individual practitioner” for people who can prescribe controlled substances. But it does not give every clinician automatic DEA power. This section gives you the federal pattern: which professions can qualify, how state law acts as the gatekeeper, and where mid-level practitioners fit in.
What to Know in 10 Seconds
- Federal law recognizes “individual practitioners” as people allowed to prescribe or dispense CS.
- To prescribe CS, a person must be: licensed under state law, acting within their scope of practice, and DEA-registered (or covered by an institutional registration).
- Mid-level practitioners (NPs, PAs, etc.) can prescribe CS only to the extent allowed by state law and DEA registration.
- Pharmacists must recognize when a prescriber’s authority has obvious limits (e.g., vet prescribing for humans).
- Federal law sets the framework; state law decides who actually gets prescriptive authority in practice.
One-Line Big Picture
Federal law does not turn every licensed professional into a prescriber; it says: “If state law authorizes you to prescribe controlled substances and you are properly registered, then you count as an individual practitioner for CSA purposes.” MPJE questions live in the gap between that definition and real-world scope limits.
Federal “Prescriber Pyramid”
Top Tier – Core Practitioners
- Physicians (MD/DO)
- Dentists
- Veterinarians
- Other independent prescribers recognized by state law
Mid-Level Practitioners
- NPs, PAs, clinical nurse specialists (where allowed)
- Optometrists, podiatrists (state-specific)
- Clinical pharmacists with prescriptive authority (where allowed)
Non-Prescribers (No DEA Authority)
- Most RNs, LPNs, techs, MA staff
- Unlicensed personnel
- Anyone practicing outside state-defined scope
For MPJE, always ask: “Does state law recognize this role as a prescriber?” then: “Is this within their usual course of professional practice?”
- If state law does not authorize a role to prescribe CS, federal law will not treat them as an individual practitioner for CSA purposes.
- If state law allows limited CS prescribing (e.g., only C-III–V, or only for specific conditions), federal law respects those limitations.
- State may limit which schedules mid-levels can prescribe.
- State may require collaborative practice agreements or supervising physicians.
- State may impose additional documentation or ID requirements on mid-level CS prescribing.
- Veterinarian writing opioids for a neighbor’s chronic back pain instead of an animal patient.
- Prescriber repeatedly issuing large CS prescriptions far outside their specialty without clear rationale.
- Pattern of mail-order controlled prescriptions from an out-of-state prescriber who has no apparent legitimate patient-prescriber relationship.
Trap – “They’re Licensed, So They Can Prescribe Anything”
Being licensed in a health profession does not automatically grant CS prescribing authority. On MPJE, always ask: Does state law give this role CS authority? and Is this within their defined scope? If either answer is no, the prescription is not valid under the federal standard.
Memory hook: Think “L-S-D” – License (state), Scope, DEA registration. A controlled prescription is valid only when all three line up for the prescriber.
Internet Pharmacies & Telemedicine – Ryan Haight Act Pattern
Modern practice includes online pharmacies and telehealth. Federal law, including the framework often referred to as the Ryan Haight Act, sets rules for prescribing controlled substances online and across distances. This section gives you the exam-friendly pattern without getting lost in every technical exception.
Key Ideas for MPJE
- Controlled substance prescriptions generally require a valid patient-prescriber relationship, which historically included at least one in-person evaluation unless a specific exception applied.
- “Online questionnaire only” or “no real exam” sites are classic examples of non-legitimate CS prescribing.
- Internet pharmacies that dispense CS directly to patients must meet additional federal registration and disclosure requirements.
- Telemedicine can be legitimate if it complies with federal standards and any special telemedicine allowances, plus state law rules.
- Pharmacists must still apply corresponding responsibility when filling telehealth CS prescriptions.
Core Story
The Ryan Haight framework was designed to stop “pill mill” websites that shipped controlled substances after nothing more than an online questionnaire. Federal law expects a real, legitimate clinical relationship – whether in-person or via approved telemedicine pathways – and gives DEA tools to regulate internet pharmacies and remote prescribing.
Legitimate Telemedicine / Online Pattern (High-Level)
- Prescriber is properly licensed and DEA-registered.
- Patient receives a real clinical evaluation (historically in-person or under authorized telemedicine models).
- Documentation supports diagnosis, treatment plan, and CS need.
- Prescribing matches the prescriber’s scope of practice and usual professional standards.
- Pharmacy verifies the prescriber, reviews for red flags, and documents concerns/resolution.
Non-Legitimate Online Operation (Red Flag Pattern)
- Patients fill out a brief online questionnaire; no real exam or history review.
- Prescribers issue large CS prescriptions after minimal or no interaction.
- Website markets quick access to opioids, stimulants, or sedatives without proper evaluation.
- Prescriptions are issued across many states with little evidence of legitimate practice.
- Pharmacy repeatedly fills these prescriptions without questioning obvious red flags.
If a question describes a website shipping opioids or stimulants based solely on a short online quiz, assume that the prescriptions are not valid under federal law and that both the prescriber and the filling pharmacy may be violating the CSA.
On MPJE, any site that hides its physical address, pharmacist names, or licensing information, yet ships controlled substances nationwide, is a red flag for non-compliance with federal internet pharmacy rules.
- Telemedicine does not waive the need for a legitimate medical purpose or proper documentation.
- Prescribers must still be appropriately licensed and registered, and follow any federal telemedicine rules in force.
- Pharmacists should treat telehealth CS prescriptions with the same red-flag awareness as in-person scripts.
Trap – “If It’s Telehealth, It Must Be Illegal”
Federal law does not ban telemedicine prescribing of controlled substances. It bans sham prescribing with no real exam or relationship. On MPJE, look for whether the scenario describes a legitimate telehealth practice meeting professional standards, or a “pill mill” website using telemedicine as a disguise.
Memory hook: For online CS questions, think “R-E-A-L” – Relationship (patient-prescriber), Evaluation (real clinical exam), Authorized prescriber/pharmacy, Legitimate medical purpose. If any piece is missing, the prescription is likely not valid under federal standards.
PDMP, Red Flags & “Know Your Patient” – Federal Concept, State Tools
Federal law sets the diversion-prevention goals; states provide tools like Prescription Drug Monitoring Programs (PDMPs). This section gives you the federal-level mindset for red-flag monitoring, and explains how PDMP fits into the pharmacist’s corresponding responsibility.
What You Need to Recognize
- Federal law expects pharmacists to watch for abuse, diversion, and red flags.
- PDMPs are primarily state-run tools that support this duty.
- Checking PDMP (when required or appropriate) is part of a reasonable review of controlled substance use.
- A “clean PDMP” does not automatically prove a prescription is legitimate.
- Documenting concerns and resolutions is crucial when red flags arise.
Big-Picture Takeaway
Federal law says pharmacists must help prevent diversion. State PDMP systems give pharmacists a window into a patient’s CS history, but MPJE questions still focus on whether the pharmacist acted reasonably in the presence of obvious warning signs – not whether they blindly trusted a database.
PDMP – What It Helps You Do
- See a patient’s recent controlled substance fills across pharmacies (state-defined scope).
- Detect patterns like doctor shopping, overlapping opioids and benzodiazepines, and frequent early refills.
- Support clinical decisions when considering whether a prescription is appropriate to fill.
- Provide documentation that you checked controlled use when state rules require it.
PDMP – What It Does Not Do
- Does not replace clinical judgment or professional skepticism.
- Does not show all possible uses (e.g., some federal or out-of-state fills, depending on system design).
- Does not automatically bless a questionable prescription just because it shows no “duplicates.”
- Does not override state and federal requirements for legitimate medical purpose and usual course of practice.
For MPJE, treat PDMP as a support tool, not the only thing that matters.
- Multiple prescribers and pharmacies for the same drug class without clear explanation.
- High-dose opioid plus benzodiazepine plus carisoprodol “cocktail” with no obvious clinical rationale.
- Patients traveling long distances or in groups for similar controlled prescriptions.
- Repeated early refill requests without documented changes in therapy or lost medication reports.
- Questions may say “state PDMP requires a check” before dispensing certain opioids – assume this is mandatory in that hypothetical scenario.
- If PDMP reveals clear misuse patterns and the pharmacist dispenses anyway without question, that conflicts with the pharmacist’s corresponding responsibility.
- Documenting PDMP review and communication with prescribers/patients is often the safest choice.
Trap – “If PDMP Is Clean, I Have to Fill It”
A PDMP report with no duplicates does not erase other red flags. On MPJE, if a scenario shows concerning behavior (e.g., obviously non-therapeutic dose or combination) but the pharmacist fills simply because PDMP is “clean,” that is usually not consistent with federal expectations for corresponding responsibility.
Memory hook: For diversion monitoring, write “P-R-O-B-E” – PDMP, Red flags, Open-ended questions to patient/prescriber, Best judgment (documented), Escalate/report when needed. That’s the exam-friendly framework for “know your patient” under federal expectations.
Opioid Risk Management, REMS Concepts & Naloxone Distribution (Federal View)
Federal law and FDA programs add extra safeguards around high-risk opioids. This section explains the exam-level risk management pattern: what it means for a drug to have a Risk Evaluation and Mitigation Strategy (REMS), how naloxone fits into overdose prevention, and where pharmacy duties typically align with federal expectations.
High-Yield Exam Ideas
- Some opioids and other high-risk drugs have an FDA-mandated REMS program.
- REMS can require specific counseling, documentation, or enrollment by prescribers, pharmacies, and patients.
- Federal and state policy increasingly promotes naloxone for overdose risk mitigation.
- Pharmacists are expected to understand opioid risk factors and educate patients accordingly.
- State law often adds detailed naloxone standing order and dispensing rules on top of federal concepts.
Conceptual Big Picture
Think of REMS and naloxone policies as the “safety belt” around controlled substances – especially opioids. Federal law sets the controlled substance framework, FDA adds REMS to particularly risky drugs, and states layer on naloxone and counseling requirements. MPJE wants you to know the pattern, even if details vary by jurisdiction.
Risk Evaluation & Mitigation Strategy
- FDA program for certain high-risk meds (some opioids, others).
- May require special education, consent, or enrollment steps.
- Pharmacies must follow REMS requirements to dispense these drugs.
Overdose Reversal & Counseling
- Widely recognized as a key tool in opioid overdose reversal.
- Many jurisdictions allow dispensing under standing orders or protocol.
- Pharmacists often counsel patients and families on use and storage.
Who Is at Higher Risk?
- High doses or multiple CNS depressants combined.
- History of substance use disorder or prior overdose.
- Respiratory disease, sleep apnea, or significant comorbidities.
The exam rarely asks for specific brand-name REMS details; instead, it tests that you understand the concept: “special risk → special program → special steps before dispensing.”
- Pharmacists are encouraged (and sometimes required) to offer naloxone with certain high-risk opioid regimens.
- Education should include recognition of overdose signs and proper naloxone administration.
- Naloxone programs do not change the need to monitor for diversion or misuse of the underlying opioids.
Answers that promote automatic denial of all high-dose opioids for chronic pain, without individual assessment, may be just as problematic as blind dispensing. Look for options that reflect individualized risk assessment, documentation, and safety measures.
Trap – “REMS Means We Can’t Ever Dispense This Drug”
A REMS program is about conditions, not prohibition. It means you must follow specified steps (education, enrollment, documentation) before dispensing. On MPJE, answers that treat REMS as a total ban on a medication are usually wrong unless the scenario explicitly says the REMS prohibits dispensing under the given conditions.
Memory hook: For opioid risk, think “R-N-P” – REMS (special rules), Naloxone (safety net), PDMP/red-flag monitoring. Any MPJE question about modern opioid policy will touch at least one of these three pillars.
Refills, Expiration & Partial Fills – Federal Rules by Schedule
This is where the MPJE loves numbers. Federal law draws clear lines between Schedule II, III–IV, and V when it comes to refills, how long a prescription is valid, and when partial fills are allowed. State law often tightens these rules, but the federal pattern is your starting grid.
Fast Pattern by Schedule (Federal)
- C-II: NO refills under federal law.
- C-III & C-IV: Up to 5 refills in 6 months from the date issued (federal cap).
- C-V: Refills allowed as authorized by prescriber, with federal rules giving more flexibility; states may impose their own limits.
- Partial fills: special, more detailed rules for C-II; more flexibility for C-III–V.
- State law commonly adds stricter time limits or maximum day supplies for some schedules.
Big-Picture Memory Line
Think: “C-II = Zero refills”, “C-III/IV = 5 in 6 months”, “C-V = As written (subject to state overlay)”. Then layer on partial-fill and emergency rules, especially for C-II, for the full MPJE attack plan.
Refills & Partials
- Refills: none allowed under federal law.
- New Rx required each time.
- Partial fills: allowed in defined situations (patient request, pharmacy stock, LTC/hospice, etc.), with rules for timing and documentation.
Refills & Validity
- Up to 5 refills allowed.
- Within 6 months of date written.
- Additional refills beyond that require a new prescription (or a documented new order).
Refills & Flexibility
- Refills generally allowed as authorized by prescriber.
- Federal law gives more flexibility; state law may restrict.
- Some C-Vs have additional OTC or behind-the-counter rules at the state level.
Any exam answer that suggests “1 refill allowed” or “up to 5 refills” for a C-II prescription is incorrect under federal law. If more medication is needed, a new C-II prescription must be issued consistent with applicable rules.
- If a question shows a C-III prescription with 10 refills written, the pharmacy may only honor up to 5 within 6 months under federal law.
- Once 6 months have passed from the issue date, remaining refills cannot be used.
On a state MPJE, always follow the stricter rule when there is a difference between the federal flexibility for C-V and state-level limits on C-V prescribing or refilling.
MPJE questions often highlight the reason for the partial fill (patient’s choice vs pharmacy out-of-stock vs LTC/hospice) and ask if the pharmacist’s actions and documentation are consistent with federal rules and state overlays.
- Each partial is recorded like a refill/dispense, showing date and quantity.
- Once the total number of dosage units or the 6-month window (for C-III/IV) is hit, the prescription is exhausted.
- State law may impose stricter rules on how partials are handled and counted.
Trap – Confusing “Partial Fill” with “Refill”
A partial fill is not the same as a refill. A partial is simply giving less than the full authorized quantity at one dispensing event. On MPJE, answers that treat a C-II partial fill as if it were a “refill” are usually wrong under federal law; remember that C-II prescriptions can be partially filled in certain ways, but they still never get refills.
Memory hook: For refills, write “0 – 5/6 – Flex” across your notes: 0 refills for C-II, 5 in 6 months for C-III & IV, Flexible (state-limited) for C-V. Then add a side note: “Partials ≠ refills” to avoid a classic exam trap.
Emergency C-II Dispensing, Fax Exceptions & LTC/Hospice Patterns
C-II prescriptions are usually tightly controlled – written or compliant electronic only. But federal law recognizes specific emergencies and institutional settings where oral or fax orders play a role. MPJE questions love these exceptions, especially when timing and follow-up documentation are involved.
High-Yield Emergency & Fax Ideas
- C-II prescriptions are generally not oral or faxed, except in defined situations.
- Emergency C-II oral dispensing is limited and requires a prompt follow-up written or electronic prescription.
- C-II fax exceptions exist for certain LTC, hospice, and specific infusion scenarios.
- The quantities and timing must match the emergency or clinical need; “routine convenience” does not qualify.
- State law may further restrict or layer additional steps on top of these federal permissions.
Conceptual Big Picture
Emergency C-II rules are not loopholes to bypass normal prescribing; they are narrow safety valves to avoid patient harm when waiting for a written or electronic prescription would be dangerous. LTC and hospice fax exceptions similarly exist to match how these settings actually work, while still preserving accountability and documentation.
Limited, True Emergency Only
- Prescriber may phone in limited C-II in a genuine emergency.
- Quantity is restricted to the emergency period.
- Follow-up written/electronic prescription must arrive within required timeframe.
Fax as Original for Certain Patients
- Faxed C-II may serve as the original prescription in defined LTC or hospice scenarios.
- Appropriate documentation of patient status (e.g., LTC resident, hospice patient) is required.
- Pharmacy keeps the faxed copy as the official record.
Fax to Start Complex Preparations
- Faxed C-II orders may function as the original in certain home infusion or parenteral therapy cases.
- Supports timely preparation and coordination of complex therapies.
- Prescription still must meet all other validity and documentation requirements.
- “Routine convenience,” prescriber travel, or office backlog is not enough; the situation must be a true emergency.
- The pharmacist must reduce the oral order promptly to writing and verify prescriber identity.
- A follow-up written/electronic prescription must arrive within the timeframe specified by law, and be marked to indicate it was for an emergency.
On MPJE, if a prescriber phones in a large, long-term C-II quantity for “convenience” rather than a short-term emergent need, that scenario likely violates the federal emergency standard.
- The pharmacy must document the patient’s LTC/hospice status as part of the record.
- The faxed prescription must contain all elements of a valid C-II prescription (patient, prescriber, drug, directions, signature, etc.).
- State law may add extra requirements for LTC or hospice C-II handling and documentation.
When MPJE questions mention C-II faxes for “routine outpatient” fills without mention of LTC, hospice, or special infusion circumstances, be skeptical – the exception may not apply under federal rules, and a written or compliant electronic original would still be required.
Trap – “Any C-II Can Be Phoned or Faxed If the Doctor Asks”
Under federal law, C-II prescriptions are not generally valid by routine phone or fax. Only true emergencies and specific LTC, hospice, and certain infusion scenarios permit oral or faxed C-II dispensing. On MPJE, answers suggesting that prescriber “preference” alone makes a phone or fax C-II acceptable are almost always wrong.
Memory hook: For C-II exceptions, think “E-L-H-I” – Emergency oral (limited), LTC fax, Hospice fax, Infusion/Injectable fax. If a scenario doesn’t fit one of these four buckets, assume normal C-II rules apply.
DEA Inspections, Audits & Pharmacy Rights – What MPJE Wants You to Know
Federal law allows the DEA to inspect registered sites to check compliance with controlled substance requirements. This section gives you the exam-level pattern: when DEA can inspect, what they usually look at, and what rights and responsibilities the pharmacy has in those encounters.
Inspection Pattern – MPJE Focus
- DEA may inspect registered locations to review records, inventories, and security for controlled substances.
- Pharmacies must keep required records readily retrievable and organized for inspection.
- Inspectors distinguish between administrative inspections and criminal searches.
- Pharmacists and owners have rights when inspections occur, including understanding the scope and basis for the visit.
- Professional, cooperative conduct plus accurate records are key to a successful inspection outcome.
Big-Picture Story
DEA inspections are designed to verify that registrants are following recordkeeping, security, and dispensing requirements for controlled substances. MPJE questions focus on recognizing what is reasonable for DEA to review and how a pharmacist should respond, not on memorizing every procedural detail.
Can You Prove Where CS Went?
- DEA forms, invoices, and dispensing logs.
- Initial/biennial inventories and adjustments.
- Segregation or ready retrieval of CS records from non-CS.
Physical & Procedural Safeguards
- Storage methods (safes, cabinets, dispersion).
- Access controls and alarm systems where appropriate.
- Policies for handling, counts, and suspected diversion.
Usage & Red Flags
- High-volume prescribers or drugs compared to peers.
- Unusual combinations or dosing patterns.
- Documentation showing pharmacists resolved red flags.
Questions often present a scenario where DEA asks to review specific records. The key is whether the request is reasonably related to controlled substances and whether the pharmacy maintains those records properly.
- Have a designated contact person (e.g., PIC, manager) for inspections.
- Know where CS records are stored and how to retrieve them quickly.
- Document key aspects of the inspection, including requested records and follow-up steps.
The exam is not asking you to give legal advice; it is testing that you understand inspections are lawful tools to monitor CS compliance, and that the pharmacy should maintain records in a way that supports smooth inspections without obstructing appropriate oversight.
Trap – “Fix the Records Before DEA Sees Them”
Altering or destroying records in anticipation of an inspection is a serious violation. On MPJE, answers suggesting that a pharmacist should “clean up” or “recreate” controlled substance records before DEA sees them are almost always wrong under federal law and professional ethics.
Memory hook: For DEA inspections, think “R-S-P” – Records (accurate, retrievable), Security (appropriate to risk), Professional cooperation. If you protect those three, most MPJE inspection scenarios line up in your favor.
DEA Registration Changes, Closing a Pharmacy & Reporting Theft/Loss (Form 106 Concept)
Pharmacies are not static. They may move, change owners, or close. Sometimes, controlled substances are lost or stolen. This section lays out the federal pattern for handling registration changes and significant theft or loss, including the concept of DEA Form 106.
Key MPJE Ideas
- DEA registration is tied to a specific location, business, and registrant.
- Changes in ownership, address, or business structure may require new or modified registration.
- Closing a pharmacy involves secure disposition of controlled substances and records.
- Significant theft or loss of controlled substances must be reported to DEA using a process that includes Form 106.
- Pharmacists and owners must investigate discrepancies and document findings, even when they are not ultimately “significant” losses.
Big-Picture Frame
Federal law expects registrants to keep DEA informed when controlled substance risks change – whether through relocation, ownership change, closure, or loss/diversion. MPJE questions test whether you recognize when action is required and what that action looks like in general terms.
Address, Ownership, Structure
- Registration is specific to location and registrant.
- Moves, mergers, or ownership changes may require new DEA actions.
- Always notify DEA when registration details materially change.
Drugs & Records Must Go Somewhere Safe
- Securely transfer or dispose of remaining CS inventory.
- Preserve prescription and CS records for required retention period.
- Notify DEA and state agencies as required for closure.
Investigate & Report if Significant
- Investigate discrepancies in CS counts or deliveries.
- Determine whether the loss is “significant” in context.
- Report significant theft/loss to DEA using Form 106 process.
Exam questions may ask whether a new owner can “just start using” the prior owner’s DEA number. The safe federal answer is that DEA registration is not automatically transferable; proper DEA processes must be followed when ownership or control changes.
- Plan CS transfers or destruction in advance of closure.
- Notify DEA and state boards in accordance with applicable procedures.
- Designate a custodian for remaining records and communicate contact information as required.
- Quantity lost relative to normal dispensing volume.
- Specific controlled substances involved (e.g., high-risk opioids).
- Pattern or history of similar incidents at the same site.
- Whether the loss appears due to diversion, robbery, or systematic weakness.
Answers that suggest “ignore small losses” or “wait to see if it happens again before investigating” are inconsistent with federal expectations. The better approach is to investigate promptly, document findings, and report when appropriate.
Trap – “Only Armed Robberies Matter”
Significant loss can occur through many mechanisms – break-ins, diverted deliveries, pattern of missing doses, or internal diversion – not just armed robbery. On MPJE, any scenario describing substantial or suspicious missing controlled substances should trigger investigation and possible Form 106 reporting, not a “wait and see” approach.
Memory hook: For this section, think “C-C-L” – Change registration when ownership/location shifts, Close with proper disposition of drugs and records, Loss/theft → investigate and, if significant, report with Form 106.
Federal Food, Drug, and Cosmetic Act (FDCA) – Drug Definitions, Legend vs OTC, Adulteration & Misbranding
The FDCA is the foundation of federal drug law. While the CSA focuses on controlled substances, FDCA rules apply to all prescription and OTC drugs. MPJE expects you to recognize the core FDCA vocabulary: drug vs device vs cosmetic, legend vs OTC, and the difference between adulteration and misbranding.
FDCA – Exam Must-Know Concepts
- The FDCA defines what counts as a “drug”, “device”, “cosmetic”, and dietary supplement.
- “Legend drugs” (Rx-only) vs OTC – who decides, and what labeling must say.
- Difference between adulteration (product quality/conditions) and misbranding (labeling and information problems).
- The role of official compendia (e.g., USP–NF) in setting identity/quality standards.
- How recalls and warnings fit into FDCA enforcement (manufacturer-driven but pharmacy-affected).
Big-Picture Frame
Think of FDCA as answering: “What is this product, how is it labeled, and is it safe and effective for its claims?”. CSA then layers on “Is this controlled and how tightly?”. MPJE questions often blend both – FDCA errors can make a drug illegal to dispense even if it is not a controlled substance.
Intended to Treat or Affect the Body
- Intended for diagnosis, cure, mitigation, treatment, or prevention of disease.
- Or intended to affect structure or function of the body (other than food).
- Intent is based on labeling, advertising, and how the product is marketed.
Acts Mechanically, Not Chemically
- Also for diagnosis, cure, or treatment – but
- Does not achieve primary purposes through chemical action or being metabolized.
- Examples: syringes, infusion pumps, blood pressure cuffs.
Appearance vs Health Claims
- Cosmetic: intended for cleansing, beautifying, or altering appearance.
- Dietary supplements: special category with its own labeling rules.
- If they make disease-treatment claims → they can be treated as “drugs.”
- Legend drugs must bear the federal “Rx-only” legend on labeling.
- OTC products must have directions that a layperson can follow safely.
- Some drugs can switch from Rx to OTC status when FDA determines they can be self-used safely (Rx→OTC switch).
- Adulteration: drug made in unsanitary conditions; wrong strength; contamination.
- Misbranding: missing “Rx-only” where required; incorrect directions; false claims; missing required warnings.
- A product can be both adulterated and misbranded at the same time if multiple problems exist.
Pharmacies rely on manufacturers and distributors to meet compendial standards, but when recalls or quality alerts occur, pharmacies must respond appropriately to avoid dispensing adulterated products.
The exam usually doesn’t require recall “class” labels in detail; it cares that you do not continue dispensing recalled lots and that you document your response to recall notices.
Trap – “It’s Only Misbranding, We Can Still Dispense It”
Under FDCA, both adulterated and misbranded drugs are prohibited in interstate commerce. On MPJE, any answer that dismisses a clear misbranding issue (e.g., missing required warning) as “just a labeling problem” and says to keep dispensing is usually incorrect under federal law.
Memory hook: For FDCA basics, use “D-L-A-M” – Definitions (drug/device/cosmetic), Legend vs OTC, Adulteration, Misbranding. Most federal non-controlled MPJE questions start from one of those four pillars.
Generic Substitution, FDA “Orange Book” & Biosimilar Concepts – Federal Baseline
Federal law and FDA references define which products are therapeutically equivalent and when they can be substituted. State law determines when substitution is allowed or required, but MPJE expects you to know the federal vocabulary: Orange Book, therapeutic equivalence codes, and the high-level pattern for biosimilars.
Federal Substitution Concepts to Know
- FDA “Orange Book” identifies therapeutically equivalent small-molecule products.
- Therapeutic equivalence codes (e.g., “A” vs “B”) signal whether products can be substituted at the federal level.
- States decide whether substitution is mandatory, permissive, or restricted.
- Biosimilars are regulated differently from generics, but have a similar “can we substitute?” question.
- Brand medically necessary / DAW instructions may limit substitution depending on state law.
Big-Picture View
FDA decides whether two products are “equivalent enough” to swap; state law tells the pharmacist when and how to swap. MPJE questions often show a product with an Orange Book code and ask if substitution is appropriate given state rules and prescriber instructions.
Therapeutic Equivalence Reference
- Lists approved drug products with therapeutic equivalence evaluations.
- Used by pharmacists to guide generic substitution decisions.
- “A” codes indicate no known bioequivalence problems; “B” codes indicate issues or insufficient data.
A vs B – High-Level Meaning
- A-rated: considered therapeutically equivalent to reference product.
- B-rated: not considered therapeutically equivalent at this time.
- States typically allow substitution only when the generic is A-rated to the prescribed brand.
Biologic Substitution Pattern
- Biosimilars are “highly similar” to a reference biologic, but not identical generics.
- FDA may designate certain biosimilars as “interchangeable.”
- States decide when pharmacists may substitute an interchangeable biosimilar without new prescriber order.
- If a product is B-rated, substitution is usually not allowed as an automatic generic swap.
- Some states require pharmacists to inform patients or prescribers when substitution occurs.
- Cost savings and formulary preferences often push toward A-rated generics when permitted.
On MPJE, when a clearly worded “no substitution” instruction appears and state law respects such instructions, the safest answer is to dispense the brand or obtain prescriber approval before substituting, even if an A-rated generic exists.
- Substitution generally applies only when the biosimilar is designated “interchangeable,” not merely biosimilar.
- States may require prescriber notification or patient consent when biosimilar substitution occurs.
- Pharmacists must know where to find current lists of interchangeable biosimilars (federal references/state resources).
Trap – “If It’s a Generic or Biosimilar, I Can Always Substitute”
Federal equivalence does not guarantee substitution. On MPJE, check: Is the product A-rated or designated interchangeable? What does state law say? Did the prescriber restrict substitution? Ignoring any of these is a classic exam mistake.
Memory hook: For substitution, remember “O-A-S-B” – Orange Book, A-rated generics, State substitution rules, Biosimilar interchangeability. If you walk through those four, you’ll usually land on the correct MPJE answer.
Pharmacy Compounding – 503A “Traditional” vs 503B “Outsourcing Facility” (Federal Baseline)
Federal law distinguishes between traditional pharmacy compounding and outsourcing facilities. The goal is to separate patient-specific, small-scale compounding from manufacturing. MPJE questions focus on the 503A vs 503B pattern, “essentially a copy,” and how compounding fits under the FDCA.
Compounding – Must-Know Federal Concepts
- 503A: “Traditional” pharmacy compounding for individual patients based on prescriptions (with limited anticipatory compounding).
- 503B: Outsourcing facilities – larger-scale sterile compounding under FDA oversight with current good manufacturing practice expectations.
- Compounded products are not approved drugs; they rely on 503A/503B conditions to be exempt from certain FDCA requirements.
- “Essentially a copy” of a commercially available product is a red flag unless criteria for medical need are met.
- State boards regulate day-to-day compounding practice; federal law sets national guardrails.
Big-Picture Story
FDCA, as updated by later federal compounding legislation, says: “If you compound for specific patients and meet 503A rules, you’re treated like a pharmacy, not a manufacturer. If you compound sterile drugs at scale for hospitals and clinics, you can register as a 503B outsourcing facility and live closer to manufacturer rules.”
503A – Traditional Compounding
- Patient-specific prescriptions (or limited, documented anticipatory compounding).
- Performed by licensed pharmacies or practitioners within the practice of pharmacy/medicine.
- Relies on state board regulation plus federal 503A conditions.
- Limited ability to compound products that are essentially copies of commercially available drugs, unless needed for a specific medical reason.
503B – Outsourcing Facilities
- Register with FDA as outsourcing facilities.
- May compound sterile drugs in larger batches without individual prescriptions.
- Subject to enhanced quality and inspection expectations, closer to manufacturers.
- Products can be sold to healthcare facilities but are still not FDA-approved “drugs.”
If a scenario shows a pharmacy compounding large, non-patient-specific batches for clinics nationwide, it starts to look less like 503A and more like manufacturing or 503B-type activity, which raises federal compliance questions.
- Routine compounding of a drug that is readily available in the same strength and dosage form, without a special need, is a red flag.
- Compounding to address a documented allergy or dosage form need (e.g., liquid instead of tablet) is more likely to be acceptable.
MPJE questions may reference USP standards as part of “good compounding practice” expectations – especially around sterile technique, beyond-use dating, and hazardous drug handling.
Trap – “If a Pharmacy Makes It, It’s Always Just Compounding”
Scale and intent matter. When pharmacies routinely produce large batches, ship across state lines without prescriptions, or copy commercial products without medical need, the activity can look like manufacturing, triggering federal scrutiny under FDCA rather than simple compounding protection under 503A.
Memory hook: For compounding, think “P-O-C” – Patient-specific (503A), Outsourcing facility bulk sterile (503B), Copy limits (no routine “essentially a copy” without medical need).
OBRA-90, Prospective Drug Utilization Review & Patient Counseling – Federal Concept, State Implementation
The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) created federal requirements for prospective drug utilization review (DUR) and patient counseling for certain prescriptions (originally focused on Medicaid). States then implemented their own pharmacy practice acts – many extending these protections to all patients.
OBRA-90 – MPJE Must-Know Themes
- Prospective DUR – review therapy before dispensing.
- Maintain an up-to-date patient profile (demographics, allergies, meds, diseases).
- Offer to counsel patients on new prescriptions (and sometimes refills, depending on state rules).
- Document relevant information, including counseling refusals and DUR outcomes.
- States may expand OBRA-90-style requirements beyond Medicaid to all prescriptions.
Big-Picture View
OBRA-90 is about moving pharmacy practice from “product-only” to “pharmaceutical care.” The pharmacist is expected to review therapy before dispensing and then educate the patient so that drug therapy is safe and effective.
Check Before You Fill
- Therapeutic duplication or drug–drug interactions.
- Dose/duration appropriateness and allergies.
- Clinical misuse or inappropriate therapy based on profile.
Know Your Patient
- Key demographics and contact information.
- Current medications (Rx, OTC, herbals when known).
- Allergies, disease states, and relevant clinical info.
Offer, Educate, Document
- Explain how to use the medication and what to expect.
- Discuss side effects, precautions, and what to do if problems occur.
- Document that counseling occurred or that the patient declined.
If a DUR alert or obvious problem is ignored and the pharmacist dispenses anyway, MPJE will usually treat this as failing the OBRA-90 standard and state-level expectations, especially if patient harm occurs.
- Encourage patients to report new allergies or medications.
- Use the profile at each fill, not just for new prescriptions.
- Document DUR findings and interventions (e.g., prescriber contact and resulting changes).
- Some states require counseling (or offer) for all new prescriptions; some also for refills with changes.
- Refusal typically must come from the patient or caregiver, not from staff on their behalf.
- Documentation of refusal is good practice and may be required by state rule or policy.
Answers that describe “handing out the leaflet only” as a substitute for verbal counseling, without an offer or opportunity to ask questions, often fail the spirit of OBRA-90-style counseling standards unless the patient explicitly declines discussion.
Trap – “Let the Tech Handle All Counseling”
OBRA-90 counseling obligations fall on the pharmacist. Technicians may assist (e.g., offer counseling or gather information), but final counseling and clinical judgment remain a pharmacist function. On MPJE, an answer that shifts clinical counseling entirely to technicians is rarely consistent with law or professional standards.
Memory hook: For OBRA-90, think “P-P-C” – Profile (keep it updated), Prospective DUR (check therapy before filling), Counsel (offer, educate, document). Most MPJE questions about OBRA-90 boil down to whether you protected all three.
HIPAA, Patient Privacy, Pharmacy Records & Disclosures – Federal Framework
Federal privacy rules – especially HIPAA – set standards for how pharmacies handle protected health information (PHI). MPJE questions focus on who can see what, when, and why, plus how long records must be kept and when information may be shared without patient authorization.
Privacy & Records – MPJE Must-Know Themes
- What counts as PHI and who is a covered entity.
- Permitted uses/disclosures for treatment, payment, and health-care operations.
- When authorization is required vs when disclosure is allowed/required without it.
- Patient rights to access, inspect, and request amendments to their records.
- Record retention duties (federal minimums vs often longer state requirements) and secure disposal.
Big-Picture View
Privacy law is not about locking everything away forever – it’s about controlled, documented, appropriate use. MPJE questions ask whether the pharmacist shared PHI in a way that fits a permitted purpose and respected patient rights.
Identifiable Health Information
- Information that identifies the patient plus relates to health or payment for care.
- Includes prescriptions, profiles, insurance data, and counseling notes.
- Paper, electronic, and verbal PHI all count.
Treatment, Payment, Operations
- Treatment: sharing with prescribers or other pharmacies for care.
- Payment: billing plans, prior auth, audits.
- Operations: quality improvement, internal training, fraud detection.
Access, Amend, Restrict
- Access/copy their own records, with limited exceptions.
- Request corrections or add statements of disagreement.
- Request restrictions or confidential communication methods.
If a scenario shows PHI shared for an unrelated purpose (e.g., marketing a third-party product) without patient authorization, that often falls outside TPO and may require specific permission or be prohibited.
- Patient authorization must describe what will be shared, with whom, and for what purpose.
- Patients can generally revoke authorization prospectively.
- Disclosures required by law (e.g., certain public health reports) do not require authorization, but must follow legal limits.
When exam questions present different retention periods, the safe approach is: “Follow the longest/strictest rule that applies in your jurisdiction.”
- Verify the identity/authority of requestors when law enforcement seeks PHI.
- Document what was requested, what was disclosed, and under what legal basis.
- When in doubt on a real case, pharmacists consult privacy officers or legal counsel; on MPJE, pick the answer that honors legal limits and documentation.
Trap – “If They’re in the Pharmacy, I Can Say Anything Out Loud”
HIPAA expects pharmacies to reasonably safeguard PHI. On MPJE, answers that endorse loudly discussing diagnoses or medication details in crowded public areas, when privacy could easily be improved, usually conflict with federal privacy expectations and good practice.
Memory hook: For HIPAA, think “P-T-A-R” – PHI (what you protect), TPO (routine allowed uses), Authorization (when you go beyond TPO), Retention & rights (keep records, respect access).
Federal MPJE Game Plan – Scenario Trainer, Rapid Review & Exam Mindset
You’ve seen the rules. This section shows you how to think like the exam: pattern recognition, trap-spotting, and rapid review. Use it as your last-page checklist before test day and as a coaching script for how to attack tricky federal questions.
How Federal MPJE Questions Are Built
- Most items are short clinical or operational vignettes, not pure memorization.
- They stress conflicts: federal vs state, prescriber vs pharmacist, convenience vs compliance.
- Many questions are “pick the most correct or least dangerous” answer.
- Traps often reward reading the exact schedule, setting, or exception in the stem.
- Safe choices usually protect patient safety, documentation, and the stricter rule.
Mindset Summary
Approach every question as the pharmacist of record: “If I sign my name to this action, will it hold up to DEA, FDA, HIPAA, and my state board?” If an answer feels “easy” but sloppily documented or casual about red flags, the exam usually wants you to say no, slow down, or clarify.
5-Step Federal Scenario Checklist
- Identify the schedule & drug type: C-II vs C-III/IV vs non-controlled vs biologic vs compounded?
- Spot the setting: retail, LTC, hospice, hospital, telehealth, mail order?
- Find the tension: emergency vs convenience, safety vs speed, legal vs “patient demand”?
- Apply the strictest relevant rule: federal baseline, but state can tighten.
- Document & communicate: when in doubt, call, clarify, document, and consider safer alternatives.
One-Line Mnemonics Wall
- Corresponding Responsibility: “If you wouldn’t sign it in court, don’t fill it at work.”
- Refills: “0 – 5/6 – Flex” (C-II, C-III/IV, C-V).
- Emergency C-II: “E-L-H-I” exceptions (Emergency oral, LTC fax, Hospice fax, Infusion fax).
- Substitution: “O-A-S-B” (Orange Book, A-rated, State rules, Biosimilar interchangeability).
- OBRA-90: “P-P-C” (Profile, Prospective DUR, Counsel).
- Compounding: “P-O-C” (Patient-specific, Outsourcing, Copy limits).
| Theme | Federal Pattern | What MPJE Usually Tests |
|---|---|---|
| CSA Schedules & Prescribing | Schedule I–V framework, legitimate medical purpose, usual course of practice, corresponding responsibility. | Is the prescription valid? Is the pharmacist ignoring obvious red flags? |
| Refills & Partials | C-II no refills; C-III/IV 5 refills in 6 months; C-V flexible. Partials ≠ refills. | Did the pharmacist mis-treat a partial as a refill, or exceed time/quantity limits? |
| C-II Exceptions | Narrow emergency oral and fax exceptions (LTC, hospice, certain infusions). | Is this a true exception, or just prescriber convenience? |
| FDCA Core & Quality | Legend vs OTC, adulteration, misbranding, recalls. | Is the product legal to dispense based on labeling and quality issues? |
| Substitution & Equivalence | Orange Book A vs B, biosimilar vs interchangeable biosimilar. | Is substitution allowed, required, or blocked by prescriber/state rules? |
| Compounding | 503A traditional vs 503B outsourcing, “essentially a copy” limits. | Is this prescription-level compounding or unapproved manufacturing in disguise? |
| OBRA-90 & Counseling | Prospective DUR, profile, offer to counsel, documentation. | Did the pharmacist ignore alerts, skip counseling, or fail to document refusals? |
| Privacy & HIPAA | PHI, TPO uses, authorization, patient rights. | Was PHI shared appropriately and reasonably safeguarded? |
Trap – “Federal Always Wins”
On practice exams, you’ll hear “federal vs state: follow the stricter rule.” On MPJE, that’s the safe default: if federal says “at most X” and state says “at most Y,” do whichever is more protective of patients and diversion risk. Only pick the looser rule if the question very clearly tells you to use that jurisdiction’s standard.
Final memory hook: When in doubt on a federal MPJE item, run this mental script:
- Is the prescription valid? (correct prescriber, schedule, legitimate purpose)
- Is the product legal? (not adulterated/misbranded, correct substitution rules)
- Are records, privacy, and documentation protected?
- Am I ignoring a red flag or exception detail?
If your chosen answer checks all four boxes, you’re usually landing on the federally safe MPJE choice.