Universal Multistate Pharmacy Jurisprudence Examination (UMPJE) Review

Comprehensive vocabulary flashcards covering federal pharmacy law, licensing requirements, compounding standards, controlled substance regulations, and practice standards for the UMPJE.

Board of Pharmacy

A state administrative agency empowered by the legislature to regulate pharmacy practice and ensure public safety, typically composed of licensed pharmacists and consumer-representing public members appointed by the Governor.

Summary Suspension

An emergency disciplinary action issued by the Board to immediately halt a licensee's practice without a prior hearing if they pose an imminent danger to public health.

NAPLEX Score Transfer

A process allowing candidates who have passed the NAPLEX within the past $89\text{ days}$ to transfer their examination score to another state licensing board.

Standard Pharmacist Intern Hours

The uniform standard of $1{,}740\text{ hours}$ of supervised practical experience (with some states retaining a baseline of $1{,}500\text{ hours}$) required prior to pharmacist licensure.

FPGEC Certification

A credential required for graduates from non-U.S. pharmacy schools (requiring a $5\text{-year}$ curriculum for post-$2003$ graduates) that includes the FPGEE, TOEFL iBT, and completion of intern hours in the United States.

Two-File Record System

A prescription storage system separating Schedule II hard copies into one file and all other prescriptions (Schedules III–V and non-controls) into a second file, requiring Schedule III–V scripts to be made readily retrievable using a red "C" stamp.

Controlled Substance Transfer Notice (DEA)

A mandate requiring written notification to the DEA at least $14\text{ days}$ in advance of a proposed transfer of controlled substances due to pharmacy ownership change or closure.

Section 503A Compounding Pharmacy

A state-licensed pharmacy that prepares compounded medications pursuant to patient-specific prescriptions or in limited anticipatory quantities based on historical valid prescription orders, adhering to USP standards.

Section 503B Outsourcing Facility

A compounding facility that must register with the FDA, comply with Current Good Manufacturing Practices (cGMP), and is permitted to compound sterile drugs for office stock without requiring patient-specific prescriptions.

Interstate Compounding 5% Rule

A federal restriction prohibiting a Section 503A pharmacy from distributing more than $5\%$ of its total prescription orders out-of-state unless its home state has entered into a Memorandum of Understanding (MOU) with the FDA.

USP

Default stability limits for non-sterile preparations: $14\text{ days}$ refrigerated for non-preserved aqueous liquids; $35\text{ days}$ at room temperature or refrigerated for preserved aqueous liquids; $90\text{ days}$ for oral nonaqueous formulations; and $180\text{ days}$ for other nonaqueous formulations.

Combat Methamphetamine Epidemic Act (CMEA) Limits

Federal limits on scheduled listed chemical products (pseudoephedrine, ephedrine, PPA) restricting sales to $3.6\,\text{g/day}$, $9\,\text{g/30-day}$ at retail, and $7.5\,\text{g/30-day}$ via mail order.

Non-Prescription Schedule V Sales Limits

A federal provision allowing dispensing of non-legend Schedule V preparations without an Rx within a $48\text{-hour}$ window, capped at $240\,\text{ml}$ ($8\,\text{oz}$) of opium or $120\,\text{ml}$ ($4\,\text{oz}$) of any other Schedule V substance.

PREP Act Vaccine Authority

Federal authority extended through $2029$ permitting pharmacists and pharmacy technicians nationwide to administer COVID-19 and seasonal influenza immunizations to individuals aged $3\text{ years}$ and older.

Corresponding Responsibility

The legal doctrine establishing that the dispensing pharmacist bears equal responsibility with the prescribing practitioner to ensure a controlled substance order is issued for a legitimate medical purpose in the usual course of professional practice.

Drug Regimen Review (DRR)

A clinical service that a consultant pharmacist must conduct and document at least once monthly for every resident residing in a Long-Term Care Facility (LTCF).

USP

Quality standards governing the preparation, compounding, and dispensing of radiopharmaceuticals, requiring cleanroom engineering controls such as ISO Class 5 Primary Engineering Controls (PECs).

Central Fill Pharmacy

A pharmacy operating at a separate registered facility that prepares prescriptions for Schedules II–V and non-controls on behalf of a delivering retail pharmacy with which it shares common ownership or a contractual agreement.

5% Controlled Substance Distribution Rule

A federal regulation permitting a retail pharmacy to distribute controlled substances to a practitioner for office use without registering as a wholesaler, provided total dosage units distributed do not exceed $5\%$ of all CS units dispensed and distributed in a calendar year.

Extra-Label Drug Use (ELDU)

The administration or dispensing of an approved drug to an animal for an unapproved indication, species, or route, strictly permitted only by a veterinarian within a valid Veterinarian-Client-Patient Relationship (VCPR).

Personal Importation Exemption (Controlled Substances)

A federal customs rule permitting a U.S. resident to import up to $50\text{ dosage units}$ of a controlled substance in personal possession across the border, provided it is declared at customs and kept in its original container.

DEA Form 106

The formal reporting form submitted to the DEA within $45\text{ days}$ following an initial written notification (due within $1\text{ business day}$ of discovery) regarding the theft or significant loss of controlled substances.

HIPAA Breach Notification Rule

The mandate requiring covered entities to notify affected individuals of a PHI breach within $60\text{ days}$ of discovery, and to alert the HHS Secretary and media without unreasonable delay if the breach impacts more than $500\text{ individuals}$.

Elements to Assure Safe Use (ETASU)

Specific clinical safety components of a Risk Evaluation and Mitigation Strategy (REMS) program requiring mandatory verification before dispensing, such as checking negative pregnancy tests and RMA numbers for isotretinoin or thalidomide.

Federal Food, Drug, and Cosmetic Act of 1938

Legislation enacted following the Sulfanilamide disaster that established the legal definitions of adulteration and misbranding and required that all new drug products be proven safe before marketing.

Durham-Humphrey Amendment of 1951

An amendment that established the formal division between prescription (Legend / "Rx Only") and over-the-counter (OTC) drugs and legally recognized verbal orders and prescription refills.

Kefauver-Harris Amendment of 1962

Legislation enacted after the Thalidomide tragedy mandating that drugs be proven both safe and effective, instituting Good Manufacturing Practices (cGMP), and transferring prescription advertising oversight to the FDA.

Poison Prevention Packaging Act (PPPA) of 1970

A law mandating child-resistant closures designed so that $80\%$ of children under $5\text{ years}$ cannot open them, while $90\%$ of adults can, and prohibiting the reuse of plastic prescription vials.

Omnibus Budget Reconciliation Act of 1990 (OBRA '90)

A statute requiring states seeking Medicaid funding to mandate pharmacist prospective Drug Utilization Review (DUR), an offer to counsel patients, and the maintenance of comprehensive patient profiles.

Adulteration

A statutory drug violation centered on physical composition, purity, facility sanitation, cGMP compliance, or deviation from official compendial (USP) strength standards.

Misbranding

A statutory drug violation centered on false or misleading labeling, missing "Adequate Directions for Use," unauthorized dispensing without a valid Rx or refill, failure to include a required MedGuide, or non-compliance with PPPA packaging rules.

FDA Class I Recall

The highest severity recall category, designating a reasonable probability that exposure to or use of a violative product will cause serious adverse health consequences or death.

FDA Class II Recall

A recall category where product exposure may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health effects is remote.

FDA Class III Recall

A recall category designated for violative products that are not likely to cause adverse health consequences, such as minor container dirt or cosmetic labeling issues.

Orange Book

The FDA reference publication listing approved drug products evaluated for Therapeutic Equivalence, using "A" ratings to indicate products that are therapeutically equivalent generic substitutes.

Purple Book

The FDA reference database listing biological products, including evaluations identifying biosimilarity and designating interchangeable biological products.

Medicaid Tamper-Resistant Prescription Mandate

Federal standards requiring all written Medicaid prescriptions to contain three security features: one preventing unauthorized copying ("VOID" pantograph), one preventing erasure/modification, and one preventing counterfeit forms.

Schedule II Fax-as-Original Exceptions

The three circumstances in which a faxed Schedule II prescription may serve as the original hard copy: injectable drugs compounded for home infusion, LTCF residents, and hospice patients.

SUPPORT Act Electronic Prescribing Mandate

A federal law mandating electronic prescribing for all Schedule II–V controlled substances under Medicare Part D, subject to narrow exceptions such as prescribers issuing fewer than $100\text{ CS scripts/year}$.

Emergency Schedule II Oral Order Rule

A DEA provision allowing oral transmission of a Schedule II prescription in an emergency, limited to the immediate quantity needed, provided the practitioner delivers a covering script within $7\text{ days}$.

Schedule II 90-Day Multiple Prescriptions Rule

A DEA provision permitting a prescriber to issue multiple Schedule II scripts on the same date for up to a total of a $90\text{-day supply}$, provided each script clearly indicates the earliest fill date.

DEA Number Validation Algorithm

A mathematical formula where the sum of digits $1$, $3$, and $5$ is added to twice the sum of digits $2$, $4$, and $6$, with the final digit of the resulting total matching the $7\text{th}$ digit of the DEA number.

CSOS Digital Certificate

A Public Key Infrastructure (PKI) credential obtained from the DEA that enables registrants to order Schedule I and II controlled substances electronically, functioning as the electronic equivalent of DEA Form 222.

DEA Form 224a Registration Renewal

The re-registration application filed every $3\text{ years}$ by pharmacy dispensers to maintain DEA registration, carrying an associated renewal fee of $\$888$.

DEA Form 222 Execution Rules

Federal requirements for ordering CI and CII substances restricting each form to one item per line across a maximum of $20\text{ lines}$, with separate forms mandated specifically for carfentanil, etorphine, and diprenorphine.

Three-Day Rule for Acute Opioid Withdrawal

An exception permitting an individual practitioner not registered as an Opioid Treatment Program (OTP) to administer (not prescribe) narcotic drugs to relieve acute withdrawal symptoms for up to $3\text{ days}$ while arranging long-term referral.

Methadone Dispensing Restrictions

Federal rules permitting retail pharmacies to dispense methadone solely for analgesia (pain management), while strictly prohibiting retail dispensing for opioid use disorder (which is restricted to DEA-registered OTP facilities).

Mid-Level Practitioner (MLP)

Healthcare providers (such as Nurse Practitioners, Physician Assistants, and Optometrists) whose DEA registration begins with the letter "M" and whose controlled substance prescribing authority is strictly dependent upon state-specific scope of practice laws.