Title II · Study
Federal pharmacy law for the MPJE: what is tested and where candidates slip
Federal pharmacy law for the MPJE® (Multistate Pharmacy Jurisprudence Examination) is mostly two statutes: the Controlled Substances Act with DEA’s rules in 21 CFR Part 1300 onward, and the Food, Drug, and Cosmetic Act, plus a few narrower acts such as the PPPA, OBRA-90 and the CMEA. That law is the same in every state. A state MPJE grades you by your state’s rule wherever it is stricter, so this page gives the federal floor, a citation for every number, and a flag wherever boards commonly build higher.
Checked against NABP and federal sources on October 19, 2026.
§ 1 Why federal law matters on both the MPJE and the Uniform MPJE (UMPJE)
NABP builds a separate MPJE for each jurisdiction and tells candidates to answer under the law of the state where they seek a license. No item is labeled “federal” or “state”. Federal rules still reach every version, because a pharmacy in any state dispenses controlled substances under the same DEA registration, the same 21 CFR 1306 and the same label warning.
The UMPJE, adopted by 13 jurisdictions as of October 19, 2026, makes this explicit: NABP says it tests general principles of state law that are uniform across jurisdictions, alongside applicable federal law.
State MPJE
- One exam per jurisdiction, keyed to its law
- A stricter state rule is the graded answer
- Score cannot be transferred
Uniform MPJE (UMPJE)
- One exam for all adopting jurisdictions
- Uniform state-law principles plus federal law
- Score transfers between adopting states
The tell Either way, learn the federal rule first, then check whether your state moved the number.
Under the current Competency Statements (exams through February 28, 2027), federal controlled-substance rules fall mostly in Area 2 (Pharmacist Practice, 33%), Area 3 (Dispensing Requirements, 24%) and Area 4 (Pharmacy Operations, 21%). From March 1, 2027 the new outline gives controlled substances their own subdomain: inventory, records, order forms, DEA registration, theft and loss, disposal. The study guide maps all four areas.
§ 2 Controlled Substances Act: schedules and what each allows
The Controlled Substances Act sorts drugs into five schedules, listed by DEA in 21 CFR 1308.11–1308.15. The schedule decides how a drug is ordered, whether it can be phoned in, how many refills it allows and how it is counted at inventory.
| Schedule | Examples listed by DEA | Prescription | Refills (federal) |
|---|---|---|---|
| CI | Heroin, LSD; marijuana outside the categories moved in 2026 | None: no accepted medical use | Not applicable |
| CII | Oxycodone, hydrocodone, methylphenidate, lisdexamfetamine | Written or electronic; oral only in an emergency | None (1306.12(a)) |
| CIII | Buprenorphine, ketamine, anabolic steroids, codeine combinations up to 90 mg per dosage unit | Written, electronic, oral or fax | Up to 5 within 6 months (1306.22) |
| CIV | Alprazolam, diazepam, tramadol, zolpidem, carisoprodol | Written, electronic, oral or fax | Up to 5 within 6 months (1306.22) |
| CV | Pregabalin, lacosamide, codeine preparations up to 200 mg per 100 mL | Written, electronic, oral or fax | As the prescriber authorizes |
Examples are a short selection from the DEA lists. Your state can schedule a drug that DEA does not, or place one in a stricter schedule.
Source: eCFR, 21 CFR Part 1308, checked October 19, 2026
Learn the schedules by drug name. Stems rarely say “a Schedule IV drug”; they say “zolpidem”, and you supply the schedule and then the rule. Hydrocodone is the classic slip: it is on the Schedule II list, so hydrocodone combination products follow the CII rules, refill ban included.
§ 3 DEA registration and forms (222 / CSOS, 41, 106, 224): what the exam asks
DEA forms are logistics, which makes them cheap points: each has a number, a job and usually a clock. A distractor that names the wrong form for a task is one of the most common on the exam.
| Form | What it is for | The detail that gets tested |
|---|---|---|
| 224 / 224a | Registration (and renewal) to dispense Schedules II–V; retail pharmacies apply on it | Registration runs 3 years (21 CFR 1301.13) |
| 222 | Ordering Schedule I and II drugs, including returning CII stock to a reverse distributor | Single-sheet form; the purchaser keeps a copy and sends the original; void after 60 days (1305.13) |
| CSOS | The digitally signed electronic equivalent of the 222 | Either a 222 or a CSOS order is required for every CI–II distribution (1305.03) |
| 106 | Reporting theft or significant loss | Filed online within 45 days of discovery (1301.76(b)) |
| 41 | Record of destroying controlled substances | Signed by the two employees who witnessed the destruction (1304.21) |
Source: eCFR, 21 CFR Parts 1301, 1304 and 1305, checked October 19, 2026
Theft or significant loss, in order
Step 1
Notify the DEA Field Division in writing
Within one business day of discovering the theft or loss (21 CFR 1301.76(b)).
Step 2
Work out whether the loss is significant
DEA’s factors include the quantity against the type of business, the specific drugs, who had access, and any pattern of losses.
Step 3
File DEA Form 106 online
Within 45 days after discovery, through DEA’s Diversion Control secure network. Paper Forms 106 have not been accepted since July 24, 2023.
Inventory and records
- Initial inventory on the date the pharmacy first dispenses controlled substances, then a biennial inventory at least every 2 years (21 CFR 1304.11).
- Schedules I and II: exact count. Schedules III–V: an estimate is allowed, unless an opened container holds more than 1,000 tablets or capsules, which must be counted exactly.
- Every required inventory and record is kept at least 2 years and available to DEA (21 CFR 1304.04(a)).
§ 4 Controlled-substance prescriptions: written, oral, electronic, refills, partial fills, transfers
This is the densest federal block on the MPJE, and all of it lives in 21 CFR Part 1306. The 12 practice cases at the bottom of this page come from here.
A valid prescription and corresponding responsibility
A controlled-substance prescription is valid only if issued for a legitimate medical purpose by a practitioner acting in the usual course of practice, and the pharmacist who fills it shares a corresponding responsibility (21 CFR 1306.04(a)). DEA’s Pharmacist’s Manual lists warning signs such as a patient returning far too often, prescriptions in other people’s names, and groups arriving with similar prescriptions from one prescriber.
Schedule II: how it may arrive
- Written or electronic is the rule (1306.11(a)). A faxed CII is a preview only: the original signed paper must reach the pharmacist before dispensing.
- Fax counts as the original in three cases: a CII narcotic compounded for direct parenteral, IV, IM, subcutaneous or intraspinal infusion; a resident of a long-term care facility; and a patient in a Medicare-certified or state-licensed hospice program (1306.11(e)–(g)).
- Oral in an emergency: the quantity is limited to what the emergency period needs, the pharmacist reduces it to writing at once, and the prescriber has 7 days to deliver a written or electronic prescription marked “Authorization for Emergency Dispensing”. If it does not arrive, the pharmacist notifies DEA (1306.11(d)).
Partial fills: four routes, four clocks
| Situation | Who triggers it | Remainder must be filled | Rule |
|---|---|---|---|
| CII, pharmacy short on stock | Pharmacist | Within 72 hours of the first partial fill, or the prescriber is notified and no more is supplied | 1306.13(a) |
| CII, requested (the 2016 CARA change) | Patient, patient’s agent, or prescriber | No later than 30 days after the date written (72 hours if it began as an emergency oral order) | 1306.13(b) |
| CII, LTCF patient or terminal illness | Pharmacist, for that patient group | Up to 60 days from the issue date; record “terminally ill” or “LTCF patient” | 1306.13(c) |
| CIII–V | Any | Within 6 months of issue; each partial fill recorded like a refill | 1306.23 |
In every route the total dispensed may not exceed the total prescribed. The requested CII route also requires that state law not prohibit it.
Source: eCFR, 21 CFR 1306.13 and 1306.23, checked October 19, 2026
Refills for Schedules III–V
Schedule III and IV prescriptions may be refilled up to five times, and not at all more than six months after the date issued, whichever limit comes first (1306.22(a)). After that the patient needs a new prescription. Schedule V carries no federal refill cap beyond what the prescriber authorizes. A Schedule III–V prescription may also be phoned in, if the pharmacist promptly reduces it to writing with everything 1306.05 requires except the signature (1306.21).
Transfers between pharmacies
Two federal rules apply, and items mix them up on purpose. For refills, CIII–V prescription information may be transferred one time only, unless the pharmacies share a real-time online database; then up to the refills allowed (1306.25(a)). The transferring pharmacist writes “VOID” and records the receiving pharmacy’s name, address and DEA number.
For initial filling, a DEA rule effective August 28, 2023 lets an unfilled electronic CII–V prescription move between retail pharmacies once, at the patient’s request, pharmacist to pharmacist, still electronic and unaltered (1306.08(e)–(f)).
§ 5 FDCA: adulteration vs misbranding, Rx vs OTC, labeling
The Food, Drug, and Cosmetic Act gives you two words that most FDCA items turn on. A drug is adulterated under section 501 (21 U.S.C. 351) and misbranded under section 502 (21 U.S.C. 352).
Adulterated (§501)
- What is in the product or how it was made
- Filthy, putrid or decomposed substance
- Prepared, packed or held under insanitary conditions
- Strength, quality or purity differs from what it should be
Misbranded (§502)
- What the label says, or fails to say
- False or misleading labeling
- Missing required directions or warnings
- A prescription drug dispensed without a valid prescription
The tell Ask whether the defect is in the bottle or on the bottle. Contents point to adulteration, words point to misbranding.
The prescription/OTC line is section 503(b) (21 U.S.C. 353(b)): a prescription drug is dispensed only on a written prescription, an oral one promptly reduced to writing, or an authorized refill. The same subsection makes a drug dispensed contrary to it misbranded, so “sold a legend drug without a prescription” is a misbranding answer.
Recall classes
- Class I
- A reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death.
- Class II
- Use may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote.
- Class III
- Use is not likely to cause adverse health consequences.
- Market withdrawal
- Removal or correction for a minor violation FDA would not act on, or no violation at all.
Definitions: 21 CFR 7.3. The usual distractor swaps Class I and Class III; Class I is the worst.
§ 6 Other federal acts that appear: PPPA, OBRA-90, CMEA, HIPAA, DSCSA, REMS
Each of these acts owns one narrow corner of practice, so expect one or two sharp questions apiece. Learn the trigger, the exception and the agency.
| Act | What it requires | The tested detail | Citation |
|---|---|---|---|
| PPPA (CPSC) | Child-resistant containers for prescription drugs | Waived when the prescriber directs it in the order or the purchaser asks; sublingual nitroglycerin is exempt | 15 U.S.C. 1473(b); 16 CFR 1700.14 |
| OBRA-90 | Prospective DUR and an offer to counsel Medicaid patients | States set the counseling standards; who counsels, and whom, is state law | 42 U.S.C. 1396r-8(g) |
| CMEA | Pseudoephedrine and ephedrine behind the counter or locked, with photo ID, logbook and trained staff | 3.6 g base per purchaser per day (seller); 9 g per 30 days, no more than 7.5 g of it shipped (purchaser); logbook kept 2 years | 21 U.S.C. 830(d); 21 CFR 1314.20(a); 21 U.S.C. 844(a) |
| HIPAA Privacy Rule | Protecting health information and giving patients access | Act on an access request within 30 days, one extension allowed | 45 CFR 164.524 |
| DSCSA | Electronic, package-level product tracing | Small dispensers exempt from some requirements until November 27, 2027 (as of October 19, 2026) | FDA exemptions page |
| REMS | FDA-required safety controls for specific drugs | Some limit who may prescribe or dispense (iPLEDGE for isotretinoin) | FDA |
Gram limits checked on eCFR (21 CFR 1314.20) and the U.S. Code (21 U.S.C. 830, 844) on October 19, 2026. Several states set stricter pseudoephedrine limits; some require a prescription.
Source: eCFR, U.S. Code and FDA DSCSA exemptions page, checked October 19, 2026
Oct 30, 2021
Triplicate DEA Form 222 no longer accepted
Jul 24, 2023
Paper DEA Form 106 no longer accepted
Aug 2023
CII partial fills on request; electronic CII–V transfer for initial fill
Apr 28, 2026
Medical and FDA-approved marijuana moved to Schedule III
Nov 27, 2027
DSCSA small-dispenser exemption ends
As of October 19, 2026; FDA has moved it before.
§ 7 When state law is stricter: the “stricter law wins” rule
When federal and state law both govern the same act, the pharmacy must satisfy both, which means following the stricter. A federal rule with no expiry on a CII prescription does not override a state rule that sets one. The federal rule is a floor, never a ceiling.
The federal rule is the floor. When your state builds higher, the state MPJE grades the higher rule.
Federal law sets it
- CII: no refills (1306.12(a))
- CIII–IV: 5 refills within 6 months
- Emergency oral CII: 7-day follow-up
- Controlled-substance records: at least 2 years
Your state commonly adds to it
- How long a prescription stays valid
- A fixed cap on emergency CII quantities
- Who must counsel, and when
- PDMP reporting deadlines
The tell If an answer quotes an exact number of hours or days that you cannot find in the CFR, it is probably a state number.
§ 8 Common traps, from the explanations in our practice bank
Each trap below is a wrong answer that the explanations in our federal cases correct again and again: an older rule that changed between 2021 and 2026, or a state number passed off as federal.
§ 9 Practice federal-law questions
The 12 cases below are federal rules on controlled-substance dispensing: partial fills, refills, transfers and emergency orders, each explanation citing its CFR section. None tests a state’s law. The mixed set of 60 is on MPJE practice questions; counseling and privacy are on pharmacist practice.
Casebook · 12 cases · free, no sign-up
12 cases to try now
0 of 12 answered · 0 correct
A Schedule II prescription for a patient with a documented terminal illness is partially filled. What does federal law require?
Choose A, B, C or D. The ruling lands here: verdict, reasoning, then each option annotated.
Keys: A–D answer · N next · P back
Docket closed
Docket
§ 10 Where these rules come from
Every number above was checked against these documents on October 19, 2026. When a review book and the eCFR disagree, the eCFR is current.
§ 11 Questions candidates ask
Why does a prescription label say “federal law prohibits the transfer of this drug”?
Because 21 CFR 290.5 requires that warning on every dispensed Schedule II, III and IV drug. It means handing the drug to anyone other than the patient. It has nothing to do with moving a prescription between pharmacies (1306.25, 1306.08), and a “no refills” note on a CII reflects a separate rule, 1306.12(a).
Is federal law the same on every state’s MPJE?
The law is the same; the answer key is not. Each state MPJE grades by that state’s law, so where your state is stricter its rule is correct. The UMPJE tests federal law alongside principles uniform across adopting states. Learn the federal rule first, then check your board.
Does federal law set an expiration date on a Schedule II prescription?
No. The six-month limit in 21 CFR 1306.22 covers Schedules III and IV. Many states set a CII expiry, and on their MPJEs that limit is the answer.
What federal pharmacy law book do candidates use?
Start free: the eCFR text of 21 CFR Part 1306 and DEA’s Pharmacist’s Manual, which was last revised in 2022 and predates the 2023 partial-fill and transfer rules. ASHP’s New Practitioners Forum also publishes a free law exam guide. Commercial books and courses are compared on MPJE prep compared.