Free MPJE Exam Flashcards

The pharmacy itself registers as a business (activity code: retail pharmacy) and dispenses under that registration. Individual pharmacists do NOT obtain their own DEA numbers; they act as agents of the registrant. Trap: a pharmacist working at two pharmacies is covered by each pharmacy's registration, not a personal one.

Form 224 = new registration for a retail pharmacy, hospital/clinic, practitioner, or teaching institution. Form 224a = renewal of that registration. Form 225 = manufacturer, distributor, researcher, analytical lab, importer/exporter. Form 363 = narcotic treatment program (OTP). Trap: 224a is renewal only, not a new location.

Retail pharmacy and practitioner registrations run on a three-year cycle; manufacturers and distributors renew annually. There is no grace period after expiration, and DEA no longer mails paper renewal notices, so the registrant must track the date. Trap: an expired registration means the pharmacy may not handle controlled substances at all.

One registration per principal place of business where controlled substances are manufactured, distributed, or dispensed (21 CFR 1301.12). Three exemptions: a warehouse that only stores drugs and does not distribute from that site; an office used by agents where no drugs are stored; and a practitioner's office where drugs are only prescribed, never stored, administered, or dispensed.

First letter identifies registrant type (A, B, F, G = hospital/practitioner/pharmacy/teaching institution; M = mid-level practitioner; P or R = distributor/manufacturer/researcher). Second letter is the first letter of the registrant's last or business name. Check digit: (digits 1+3+5) + 2 x (digits 2+4+6); the last digit of that sum must equal the 7th digit. Trap: the old X prefix for buprenorphine is retired.

Nurse practitioners, physician assistants, and similar prescribers get DEA numbers beginning with M. Their federal authority never exceeds what the state grants them. Trap: an M number does not by itself prove the prescriber may write for every schedule; the state may restrict them to specific schedules or require a supervising physician.

A registrant may grant power of attorney to any individual (including a non-pharmacist employee) to sign DEA Form 222 or use CSOS. The POA must be signed by the same person who signed the most recent registration or renewal application, and by the attorney-in-fact. Trap: the POA is kept on file at the pharmacy with the executed 222s; it is never sent to DEA. It can be revoked at any time.

Federal law does not define or require a PIC. The DEA registrant is the pharmacy entity, and the PIC role, its qualifications, its duties, and how quickly a change must be reported are all creations of state board law. Trap: on the MPJE, any question about PIC qualifications, ratios, or change-of-PIC deadlines is a state-law question, not a CSA question.

21 CFR 1301.90-1301.93 asks registrants to screen applicants for controlled-substance-handling jobs by inquiring about felony drug convictions in the past 5 years, misdemeanor convictions or pending charges in the past 2 years, and knowing unauthorized drug use in the past 3 years, and encourages reporting employee drug diversion to DEA. Trap: these provisions are DEA guidance for registrants, not a federal ban on hiring anyone with a drug history.

No. A registration is not transferable and terminates when the registrant dies, ceases legal existence, or discontinues business. A new owner must obtain its own registration. A change of address or business name is handled as a modification of the existing registration, which requires no fee and keeps the same DEA number.

Under 21 USC 824(a): falsifying the application, a felony conviction related to controlled substances, loss or restriction of the state license, exclusion from Medicare/Medicaid, or acts inconsistent with the public interest. DEA may issue an immediate suspension order when there is imminent danger to public health or safety. Form 104 is used for voluntary surrender. Trap: losing the state pharmacy license alone is enough to lose the DEA registration.

CI = no accepted medical use in the US, high abuse potential (heroin, LSD). CII = high potential, severe dependence (oxycodone, fentanyl, amphetamine, methylphenidate). CIII = moderate/low physical but high psychological dependence (buprenorphine, ketamine, anabolic steroids). CIV = low potential (benzodiazepines, tramadol, zolpidem, carisoprodol). CV = lowest (pregabalin, low-dose codeine cough preparations). Trap: CI is defined by lack of accepted medical use, not by danger.

21 CFR 1306.05 requires: date of issue; patient's full name and address; drug name, strength, dosage form, and quantity prescribed; directions for use; and the prescriber's name, address, and DEA registration number. A written prescription must be manually signed on the date it is issued. Trap: the patient's ADDRESS is required on controlled prescriptions even though it is optional on most non-controlled ones.

Per DEA policy, only after consulting the prescriber and documenting the agreement may a pharmacist add or change the patient's address, dosage form, strength, quantity, or directions for use. A pharmacist may NEVER change the patient's name, the controlled substance prescribed (generic substitution aside), or the prescriber's signature. Trap: this is DEA guidance rather than codified text, and many states are stricter.

Only an individual practitioner who is DEA-registered (or registration-exempt under 21 CFR 1301.23, such as military, Public Health Service, and Bureau of Prisons officials using an exempt identification number; VA prescribers instead use the VA facility registration with an individual suffix) and acting in the usual course of professional practice within the scope of state authority (21 CFR 1306.03). Trap: an agent or employee may prepare and transmit the prescription, but the practitioner must sign it; an agent may never sign for the prescriber.

21 CFR part 1311 requires identity proofing of the prescriber, a DEA-audited application, and two-factor authentication using two of: something you know (password), something you have (a hard token separate from the computer), something you are (biometric). Trap: a controlled substance prescription created electronically may not be printed out and signed by hand; it must be transmitted electronically.

A Schedule II prescription may NEVER be refilled (21 CFR 1306.12(a)). Instead, a practitioner may issue multiple separate CII prescriptions on the same day authorizing up to a 90-day total supply, each with written "do not fill before" instructions, if it is legitimate and state law permits. Trap: these are separate prescriptions, not refills, and each is subject to its own fill date.

21 CFR 1306.22: no more than 5 refills and no filling or refilling more than 6 months after the date of issue, whichever comes first. After either limit, a new prescription is required. Trap: the 6-month clock starts on the date the prescription was WRITTEN, not the date it was first dispensed.

The 5-refill/6-month rule in 21 CFR 1306.22 applies only to Schedules III and IV. A Schedule V prescription may be refilled as expressly authorized by the prescriber, with no federal numeric or time cap. Trap: many states DO impose a cap on CV refills, and the stricter law controls.

The Consolidated Appropriations Act, 2023 eliminated the DATA-waiver (X-number) and patient caps, so any practitioner with a DEA registration that includes Schedule III authority may now prescribe buprenorphine for OUD. Trap: methadone for OUD still may not be dispensed on a pharmacy prescription; it requires a SAMHSA-certified opioid treatment program. A pharmacy may dispense methadone for PAIN on a valid CII prescription.

State law, not federal law. Immunization authority, collaborative practice agreements (CPAs), test-and-treat protocols, and any independent prescribing are all granted by the state practice act and board rules, and vary widely. Trap: the CSA lists pharmacists within its definition of "practitioner," but that alone confers no prescribing authority.

The Omnibus Budget Reconciliation Act of 1990 (effective January 1, 1993) conditioned federal Medicaid funds on states requiring pharmacies to: (1) perform prospective drug utilization review, (2) offer to counsel the patient, and (3) maintain reasonable patient records/medication profiles. Trap: OBRA-90 is a Medicaid funding condition imposed on STATES; the pharmacy-level duty comes from the state law each state enacted in response.

An OFFER to counsel, not counseling itself. Federally the offer applies to Medicaid patients and may be made by the pharmacist or the pharmacist's designee, and the patient may refuse. Trap: nearly every state extended the duty to ALL patients, and many require the counseling itself to be delivered by a pharmacist even though the offer may be made by staff.

Name and description of the medication; route, dosage form, dose, and duration of therapy; special directions and precautions for preparation, administration, and use; common severe side effects, interactions, and contraindications plus the action required if they occur; techniques for self-monitoring; proper storage; refill information; and what to do about a missed dose. Trap: price is not a counseling element.

OBRA-90 requires a reasonable effort to obtain and record the patient's response to the offer, so the record must capture that the offer was made and whether it was accepted or refused. Trap: a signature log that only proves receipt of the prescription is not documentation of the counseling offer unless it separately records the counseling response.

For treatment, payment, and health care operations (TPO), plus specific public-interest exceptions such as public health reporting and law enforcement demands that meet the rule. The minimum necessary standard applies generally. Trap: minimum necessary does NOT apply to disclosures to another provider for treatment, to the patient themselves, pursuant to the patient's own authorization, or where disclosure is required by law.

Notify affected individuals without unreasonable delay and no later than 60 days after discovery. If the breach involves 500 or more individuals, also notify HHS within 60 days and provide notice to prominent media in the affected state. If it involves fewer than 500, log it and report to HHS annually, within 60 days after the end of the calendar year. Trap: the 60-day clock runs from DISCOVERY, not from the breach.

Generally no. Once a drug leaves the pharmacy's control its integrity cannot be assured, so returning it to stock risks adulteration/misbranding and it is excluded from the normal DSCSA return pathway. Narrow exceptions exist for unopened unit-dose from long-term care facilities and for state drug donation/repository programs where state law allows. Separately, the PDMA flatly prohibits selling, purchasing, or trading drug samples.

21 CFR 1306.04(a): a prescription is only valid if issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The responsibility for proper prescribing rests with the prescriber, but a CORRESPONDING responsibility rests with the pharmacist who fills it. Red flags include long distances traveled, cash payment, prescribing outside the prescriber's specialty, opioid/benzodiazepine/carisoprodol "cocktails," and early refills. Trap: a red flag does not require refusal, it requires resolution and documentation before dispensing, and a pharmacist who knowingly fills an invalid prescription faces the same penalties as the prescriber.

21 CFR 1306.25 allows transfer of original prescription information for refill purposes ONE time only, communicated directly between two licensed pharmacists. Trap: pharmacies that share a real-time, online database are the exception and may transfer up to the maximum number of refills permitted by law. Both the transferring and receiving records must be retained two years.

Only in one narrow way. A DEA final rule effective August 28, 2023 permits an ELECTRONIC controlled substance prescription (Schedules II-V) to be transferred one time between retail pharmacies for INITIAL filling, at the patient's request, before any of it has been dispensed. Trap: this does not apply to paper or oral prescriptions, the prescription must move in electronic form (never printed), and once partially filled it can no longer be transferred.

If the pharmacist simply cannot supply the full quantity, the remainder must be supplied within 72 hours or the prescriber must be notified (21 CFR 1306.13(a)). If the PATIENT or PRESCRIBER requests a partial fill (CARA 2016), the remaining portions may be filled up to 30 days from the date the prescription was written. For a long-term care facility resident or a patient with a documented terminal illness, partial fills are allowed for up to 60 days from issue.

Permitted under 21 CFR 1306.23 as long as each partial fill is recorded exactly like a refill, the total dispensed across all partial fills never exceeds the quantity prescribed, and no dispensing occurs more than 6 months after the date of issue. Trap: partial fills count against the 5-refill limit in the sense that the record is kept as a refill, but they do not increase the total quantity you may dispense.

21 CFR 1306.11(d): the quantity is limited to what is adequate to treat the emergency period only; the pharmacist immediately reduces the order to writing and must make a good faith effort to verify the prescriber's identity; the prescriber must deliver a signed written prescription within 7 DAYS marked "Authorization for Emergency Dispensing" with the date of the oral order. Trap: if the written cover prescription does not arrive, the pharmacist must notify the nearest DEA field office.

"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" is required on dispensed Schedule II, III, and IV drugs (21 CFR 290.5). Trap: Schedule V is EXEMPT from this warning. The DEA label itself (21 CFR 1306.14/1306.24) separately requires the fill date, pharmacy name and address, serial number, patient name, prescriber name, and directions for use.

Before dispensing, screen for therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect dosage or duration of treatment, drug-allergy interactions, and clinical abuse or misuse. Trap: prescription drug monitoring program (PMP) checks are NOT a federal requirement; whether you must query the PMP, and how often, is set entirely by state law.

FDCA section 503(b) makes a drug prescription-only and requires the "Rx only" legend; dispensing a legend drug without a valid prescription renders it MISBRANDED. Trap: misbranding is a labeling/information defect, while ADULTERATION is a defect in the product itself (contamination, wrong strength, insanitary conditions, failure to meet USP standards). Exam items test which of the two a given fact pattern creates.

The PPPA is administered by the Consumer Product Safety Commission, not the FDA, and requires child-resistant packaging with one important asymmetry: a PRESCRIBER may waive it for a single prescription only, while a PATIENT may sign a blanket waiver covering all of their prescriptions. Exempt products include sublingual nitroglycerin, oral contraceptives in memory-aid packaging, low-dose prednisone and methylprednisolone, pancrelipase, and unit-dose potassium supplements.

Sales limits per purchaser: 3.6 g of base per DAY and 9 g per 30 days (7.5 g per 30 days for mail order). Product must be kept behind the counter or in a locked cabinet, the purchaser must present photo ID, the seller must complete self-certification training, and the logbook (name, address, product, quantity, date and time) must be kept 2 YEARS. Trap: the limits are expressed in grams of pseudoephedrine BASE, not grams of the salt or number of packages.

21 CFR 1306.26 lets a pharmacist dispense certain CV products without a prescription: no more than 240 mL (8 oz) or 48 dosage units of an OPIUM-containing preparation, or 120 mL (4 oz) or 24 dosage units of any other CV substance, to the same purchaser in any 48-hour period. The purchaser must be at least 18, ID is required from unknown purchasers, and a bound record book is kept. Trap: a pharmacist must make the sale, and state law may still require a prescription.

21 CFR 1301.75(b) gives pharmacies two options: keep controlled substances in a securely locked, substantially constructed cabinet, OR disperse them throughout the stock of non-controlled drugs in a way that obstructs theft or diversion. Trap: dispersal is a lawful alternative, not a loophole; Schedule I and II stock at non-practitioner registrants faces stricter vault and alarm standards, and state boards often require a locked safe regardless.

A Form 222 (or an electronic CSOS order using a CSOS digital certificate) is required for every distribution, transfer, or purchase of a Schedule I or II controlled substance. Trap: Schedules III, IV, and V are ordered on an ordinary invoice or packing slip with no 222 at all; the receiving pharmacy simply keeps the invoice as a record for 2 years.

With the single-sheet form (which replaced the triplicate version in 2019), the purchaser sends the original to the supplier and keeps a copy; the supplier retains the original, and the purchaser records packages and dates received on its retained copy (21 CFR 1305.13, 1305.17). Only one item per numbered line, and the number of lines completed must be recorded. On receipt, record the number of packages received and the date received on Copy 2. Trap: any alteration, erasure, or change voids the form; mark it VOID and keep it on file rather than discarding it.

Form 223 is the Certificate of Registration itself, the document DEA issues once a registration is granted. It must be maintained at the registered location and kept available for official inspection. Trap: it is not an application or a report; candidates confuse it with Form 224 (apply), 224a (renew), 106 (theft/loss), and 41 (destruction).

An initial inventory is taken on the date the registrant first handles controlled substances, then a biennial inventory every 2 years. It must state whether it was taken at the opening or the close of business. Schedule II requires an exact count; Schedules III-V may be estimated UNLESS the container holds more than 1,000 dosage units and has been opened, in which case an exact count is required.

DEA requires records to be kept at the registered location for at least 2 YEARS and to be readily retrievable. Schedule II records must be maintained SEPARATELY from all other records; Schedules III-V may be kept separately or in a readily retrievable form. Trap: 2 years is only the federal floor. Many states require 3, 5, or 7 years, and the stricter requirement controls.

On discovering a theft or significant loss, notify the DEA Field Division Office IN WRITING within one business day, then complete Form 106. Trap: for an in-transit loss the SUPPLIER reports until the customer signs for the shipment. Breakage or spillage where the substance is accounted for is not a reportable loss; document it and use Form 41 if the recovered material is destroyed.

Form 41 records on-site destruction, which must render the substance NON-RETRIEVABLE, witnessed by two employees, and the form kept 2 years. Trap: Form 41 is never used for theft or loss (that is Form 106), and "non-retrievable" is a legal standard, not a method, so simply putting drugs in the trash or the sewer does not satisfy it.

503A traditional compounding requires a patient-specific prescription (with limited anticipatory compounding), is exempt from new drug approval, adequate directions for use, and cGMP, and must follow USP standards. A 503B outsourcing facility registers with FDA, may compound without patient-specific prescriptions, and must comply with cGMP and FDA inspection. Trap: 503B is exempt from new drug approval but NOT from cGMP.

Buy only from authorized (licensed/registered) trading partners, receive and retain transaction information and a transaction statement for 6 YEARS, quarantine and investigate suspect product, and notify FDA and trading partners of illegitimate product within 24 hours using FDA Form 3911. Trap: the 6-year DSCSA window is far longer than DEA's 2-year controlled substance window; do not merge the two retention periods.