- DEA Form 222
- The official order form required to purchase or transfer Schedule I and II controlled substances (or the electronic CSOS equivalent).
- DEA Form 224
- The application a pharmacy uses to obtain a new DEA registration to dispense controlled substances.
- DEA Form 41
- The form used to document the destruction/disposal of unwanted controlled substances.
- DEA Form 106
- The form used to report the theft or significant loss of controlled substances to the DEA.
- Schedule I
- Highest abuse potential, no currently accepted U.S. medical use (e.g., heroin, LSD). Not dispensed at pharmacies.
- Schedule II
- High abuse potential with accepted medical use; severe dependence risk (e.g., oxycodone, fentanyl, amphetamine). No refills.
- Schedule III
- Abuse potential less than CI–CII; moderate-to-low physical dependence (e.g., buprenorphine, ketamine, certain codeine combos).
- Schedule IV
- Low abuse potential relative to CIII (e.g., benzodiazepines, tramadol, zolpidem).
- Schedule V
- Lowest abuse potential; preparations with limited quantities of certain narcotics (e.g., codeine cough syrups, pregabalin).
- Schedule II refill rule
- Schedule II prescriptions may NOT be refilled. A new prescription is required each time.
- Schedule III–V refill limit
- May be refilled up to 5 times within 6 months of the date written; after that a new prescription is needed.
- Schedule II written-prescription rule
- Generally require a written (or compliant electronic) prescription; oral orders allowed only in a genuine emergency.
- Emergency Schedule II oral order
- Permitted in a bona fide emergency, limited to the amount needed for the emergency period; prescriber must deliver a written prescription within 7 days.
- Schedule II partial fill (federal)
- A partial fill is allowed; the remainder may be supplied within 72 hours, otherwise the balance is void and the prescriber must be notified.
- Schedule III–V partial fill
- Partial fills are allowed as long as each is recorded like a refill and the total dispensed does not exceed the amount prescribed within 6 months.
- Controlled-substance prescription transfer (CIII–V)
- May be transferred for refill purposes ONE time only; if pharmacies share a real-time online database, up to the maximum number of refills is allowed.
- Schedule II transfer
- CII prescriptions cannot be transferred for refilling (CII has no refills). Under a 2023 DEA rule, an ELECTRONIC CII–CV prescription may be transferred once, pharmacist-to-pharmacist, for the INITIAL fill.
- Controlled Substances Act (CSA)
- The 1970 federal law (Title 21) that classifies drugs into Schedules I–V and governs their manufacture, distribution, and dispensing through the DEA.
- DEA
- The Drug Enforcement Administration — the federal agency that registers handlers and enforces the Controlled Substances Act.
- DEA registration renewal
- A pharmacy's DEA registration must be renewed every 3 years.
- Valid DEA number check
- First letter shows registrant type; second letter is the registrant's last-name initial. Checksum: add the 1st, 3rd, and 5th digits; double the sum of the 2nd, 4th, and 6th; the last digit of the total equals the 7th (check) digit.
- Legitimate medical purpose
- A controlled-substance prescription is valid only if issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice (21 CFR 1306.04).
- Corresponding responsibility
- The dispensing pharmacist shares legal responsibility with the prescriber for ensuring a controlled-substance prescription is legitimate; knowingly filling an invalid one is a violation.
- Red flags (controlled substances)
- Warning signs of diversion — e.g., cash payment for high-dose opioids, long distances traveled, identical prescriptions for many patients, early refills, dangerous combinations.
- Power of attorney (DEA Form 222)
- A registrant may grant a power of attorney authorizing an individual to sign DEA Form 222 / CSOS orders on the registrant's behalf; it is kept on file at the registered location.
- CSOS
- Controlled Substance Ordering System — DEA's program for placing electronic Schedule I/II orders using a DEA-issued digital certificate, replacing the paper Form 222.
- DEA Form 222 completion limit (paper)
- Must be filled out and submitted to the supplier within 60 days of the order date.
- Theft/loss reporting timing
- A pharmacy must notify the DEA in writing within 1 business day of discovering a theft or significant loss, then complete DEA Form 106.
- Biennial inventory
- A complete inventory of all controlled substances must be taken at least every 2 years.
- Initial inventory
- A newly registered pharmacy must take an inventory of all controlled substances on hand on the date it first engages in handling them.
- Schedule II inventory count
- Schedule II substances must be counted EXACTLY; Schedule III–V may be estimated unless the container holds more than 1,000 dosage units.
- Controlled-substance record retention (federal)
- Controlled-substance records must be kept for at least 2 years and be readily retrievable.
- Readily retrievable
- Records can be separated from other documents or marked so that controlled-substance information is easily identifiable and produced for inspection.
- Schedule II recordkeeping
- Schedule II records must be maintained SEPARATELY from all other records.
- Schedule III–V recordkeeping
- May be kept separately OR in a readily retrievable form within the other prescription files.
- Federal transfer warning label
- Schedule II–IV labels must bear: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
- Combat Methamphetamine Epidemic Act (CMEA)
- Federal law limiting OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine; requires behind-the-counter storage, a logbook, and ID verification.
- Pseudoephedrine daily limit
- A customer may purchase no more than 3.6 grams of pseudoephedrine base per day.
- Pseudoephedrine 30-day limit
- No more than 9 grams may be purchased within a 30-day period (federal CMEA limit).
- Pseudoephedrine logbook retention
- The CMEA sales logbook must be kept for at least 2 years.
- Practitioner self-prescribing (controlled)
- Prescribing controlled substances for oneself or for office stock generally lacks a legitimate prescriber–patient relationship and is not a valid prescription.
- Telemedicine controlled prescribing
- A controlled-substance prescription via telemedicine requires a genuine evaluation and a practitioner–patient relationship consistent with federal Ryan Haight Act requirements.
- Schedule II prescription expiration (federal)
- Federal law sets no time limit for filling an unfilled CII prescription, but it must still reflect a legitimate medical need (many states do impose a limit).
- Disposal / reverse distributor
- Unwanted controlled substances are sent to a DEA-registered reverse distributor (with Form 222 for CII) and documented on DEA Form 41.
- DEA registrant types
- Manufacturers, distributors, dispensers (pharmacies/practitioners), importers/exporters, researchers, and analytical labs each register separately by activity.
- Schedule II faxed prescription (exceptions)
- A faxed CII may serve as the original for long-term-care, hospice, or home-infusion patients (and to confirm an emergency oral order).
- Multiple Schedule II prescriptions
- A practitioner may issue multiple CII prescriptions on the same day for up to a 90-day supply, with instructions on the earliest fill date for each.
- Suspicious order monitoring
- Distributors must design systems to detect and report suspicious controlled-substance orders to the DEA.
- Required prescription elements
- Patient name and address, date, drug name/strength/quantity, directions for use, prescriber name/address (and signature), and prescriber DEA number for controlled drugs.
- OBRA-90
- The Omnibus Budget Reconciliation Act of 1990 — requires offer to counsel and prospective drug-use review (DUR) for Medicaid patients; adopted broadly by states for all patients.
- Offer to counsel
- Under OBRA-90, the pharmacist (or designee) must OFFER to counsel the patient; the patient may decline, but the offer is required.
- Prospective drug utilization review (ProDUR)
- Screening a prescription before dispensing for therapeutic duplication, interactions, contraindications, incorrect dose/duration, and abuse/misuse.
- Patient counseling content
- Drug name, intended use, route/dose/duration, special directions, common side effects and how to avoid them, storage, refills, and what to do if a dose is missed.
- Generic substitution
- A pharmacist may substitute a therapeutically equivalent generic unless the prescriber indicates “dispense as written” / “brand medically necessary” or the patient refuses.
- Orange Book
- FDA's “Approved Drug Products with Therapeutic Equivalence Evaluations” — used to determine if a generic is therapeutically equivalent (A-rated) to the brand.
- Dispense as written (DAW)
- A prescriber instruction directing that the brand-name product be dispensed without generic substitution.
- Prescriptive authority by prescriber
- Physicians (MD/DO), dentists, podiatrists, veterinarians, optometrists, and mid-level practitioners (NP, PA) prescribe within the scope of their license and DEA authority.
- Podiatrist prescribing scope
- A podiatrist may prescribe only for conditions of the foot and ankle within their licensed scope.
- Mid-level practitioner DEA
- Nurse practitioners and physician assistants may prescribe controlled substances only as allowed by state law and with their own DEA registration.
- Suspended prescriber
- A prescription written while the prescriber's license or DEA registration is suspended/revoked is not valid and must not be filled.
- Fax prescription (non-controlled)
- A non-controlled prescription may be transmitted by fax and serve as the original.
- Electronic prescribing of controlled substances (EPCS)
- Allowed under DEA rules when the system meets identity-proofing, two-factor authentication, and audit requirements.
- Verbal/oral prescription
- Non-controlled and CIII–V prescriptions may be taken orally; CII generally may not except in a documented emergency.
- Clarifying an ambiguous order
- When a prescription is unclear, incomplete, or potentially in error, the pharmacist must contact the prescriber to clarify before dispensing.
- Therapeutic interchange vs substitution
- Substitution swaps a generic for the same drug; therapeutic interchange swaps a different drug in the same class, usually requiring a protocol or prescriber approval.
- Refill authorization
- Refills require prescriber authorization; without remaining authorized refills the pharmacist must obtain a new authorization.
- Emergency refill (state)
- Many states allow a limited emergency supply of a maintenance non-controlled drug when the prescriber cannot be reached; amount and conditions are set by state law.
- Drug Utilization Review (DUR) outcome
- If ProDUR detects a problem, the pharmacist exercises professional judgment — contacting the prescriber and/or counseling — before dispensing.
- Patient profile / medication record
- A record of the patient's medications, allergies, and conditions that supports DUR and counseling (required under OBRA-90 for Medicaid patients).
- Tamper-resistant prescription pad
- Medicaid outpatient prescriptions must be on tamper-resistant pads (or e-prescribed) to be reimbursed.
- Quantity vs days supply
- Quantity is the amount dispensed; days supply is how long it lasts per the directions — both are checked against the prescription.
- Pharmacist scope (vaccines/test-and-treat)
- Pharmacists may immunize and, in many states, test-and-treat under protocols or collaborative practice agreements set by state law.
- Collaborative practice agreement (CPA)
- A written agreement letting a pharmacist manage drug therapy (adjust, initiate, monitor) under a prescriber's authorization, per state law.
- Refusal to fill (conscientious/professional)
- A pharmacist may decline to fill a prescription the pharmacist believes is invalid, forged, or not for a legitimate medical purpose, and must document the basis.
- Right of the patient to decline counseling
- OBRA-90 requires the offer; the patient may refuse counseling, which is then documented.
- Forged prescription handling
- Suspected forgeries should not be filled; verify with the prescriber and follow state/federal reporting requirements.
- Schedule of the prescriber's DEA
- A prescriber's DEA registration authorizes specific schedules; the pharmacist confirms the prescriber is authorized for the controlled drug ordered.
- Patient identification for controlled dispensing
- Many states require ID for controlled-substance pickup; the pharmacist verifies the patient/agent per state rules.
- Beyond-use date (dispensed Rx)
- The date beyond which a dispensed prescription should not be used, assigned per USP guidance and the product's stability.
- Drug recall classes (FDA)
- Class I = reasonable probability of serious harm/death; Class II = temporary or reversible harm; Class III = unlikely to cause harm.
- Pharmacist's role in a recall
- Identify affected stock, quarantine it, follow the manufacturer/FDA instructions, and notify patients/prescribers as directed.
- MPJE
- The Multistate Pharmacy Jurisprudence Examination — NABP's computer-adaptive law exam (120 items: 90 scored + 30 pretest, 3 hours) combining federal pharmacy law with a specific state's law.
- MPJE competency areas
- Per NABP's current Competency Statements: Area 1 Pharmacy Practice (~83%), Area 2 Licensure/Registration/Certification & Operational Requirements (15%), and Area 3 General Regulatory Processes (2%).
- MPJE passing score
- A scaled score of 75 on a 0–100 scale; since 2021 results are reported pass/fail. Because it is computer-adaptive, the cut is not a simple percent-correct.
- UMPJE
- The Uniform MPJE — NABP's newer law exam (launched 2026) testing uniform state-law principles plus federal law using 3-option single-answer questions; replacing the MPJE in adopting jurisdictions.
- NABP
- The National Association of Boards of Pharmacy — develops and administers the NAPLEX and MPJE/UMPJE and supports state boards of pharmacy.
- Board of pharmacy
- The state agency that licenses pharmacists/pharmacies, sets and enforces practice rules, and disciplines licensees within that jurisdiction.
- NAPLEX vs MPJE
- NAPLEX tests pharmacy practice/clinical competence; the MPJE tests pharmacy law and jurisprudence for a specific state.
- State-specific MPJE
- Each state's MPJE blends FEDERAL pharmacy law with that state's own pharmacy statutes and board regulations; a separate MPJE is required for each state, and you answer per the prevailing law of that state.
- States requiring the MPJE
- 45 boards of pharmacy require an NABP law exam (MPJE or UMPJE). Arkansas, California, Nevada, and Puerto Rico give their own jurisprudence exams; a few jurisdictions require no law exam.
- MPJE/UMPJE fee
- The MPJE application fee is $100 per jurisdiction (plus state board fees). The UMPJE costs $450 total ($100 application + $350 exam), with $105 per additional jurisdiction.
- MPJE retake wait
- A candidate must wait at least 30 days between attempts and reapply each time; the number of attempts allowed is set by the state board.
- Licensure by examination
- Initial licensure path: graduate from an accredited program, pass the NAPLEX and the state's MPJE, and complete required intern hours.
- Licensure reciprocity / transfer
- Transferring a license to another state via NABP's licensure transfer process; the candidate must still pass that state's MPJE.
- Continuing education (CE)
- Ongoing education required to renew a license and maintain competence; measured in CE units/hours set by the state.
- Continuing education unit (CEU)
- A standardized measure of CE; 1 CEU = 10 contact hours (so 0.1 CEU = 1 contact hour).
- License renewal
- Pharmacist licenses are renewed periodically (commonly every 1–2 years) with required CE; lapse requires reinstatement per state rules.
- Pharmacy intern
- A student or graduate registered with the board to gain supervised practice experience toward licensure.
- Pharmacist-in-charge (PIC)
- The pharmacist legally responsible for a pharmacy's compliance with laws and regulations, including recordkeeping and operations.
- Pharmacy technician
- Supportive personnel who assist the pharmacist with dispensing tasks under supervision; registration/certification and duties are set by state law.
- Technician-to-pharmacist ratio
- The maximum number of technicians a pharmacist may supervise, set by state law (varies by state).
- Final verification
- Most states require a pharmacist to perform the final check of a dispensed prescription (some allow tech-check-tech under board-approved programs).
- Pharmacy permit/registration
- A pharmacy must hold a current state permit/registration (and DEA registration for controlled substances) to operate.
- Out-of-state / nonresident pharmacy license
- A pharmacy mailing prescriptions into a state generally must hold that state's nonresident pharmacy license.
- Change of pharmacy ownership/location
- Requires notifying the board (and modifying the DEA registration) per state and federal rules before the change takes effect.
- Disciplinary actions
- A board may suspend, revoke, fine, place on probation, or reprimand a licensee for violations such as fraud, diversion, or impairment.
- Grounds for discipline
- Common grounds include unprofessional conduct, drug diversion, fraud, substance impairment, gross negligence, and violation of pharmacy law.
- Mandatory reporting
- Licensees must report certain events (e.g., disciplinary action in another state, certain crimes) to the board as required by state law.
- Impaired-pharmacist program
- A confidential recovery/monitoring program some boards offer in lieu of or alongside discipline for substance-use disorders.
- Inspection authority
- Boards and the DEA may inspect a pharmacy's premises and records to verify compliance; controlled-substance records must be readily retrievable.
- Pharmacy closing requirements
- On closure, controlled stock is transferred or disposed of with proper documentation, and records and the DEA registration are handled per regulation.
- CE for license reactivation
- A lapsed license is reactivated by meeting the board's requirements, which often include completing back/required CE and paying fees.
- Pharmacist supervision requirement
- A pharmacy may dispense only under the supervision of a licensed pharmacist who is on duty/responsible.
- Registration vs license
- A license authorizes a person to practice; a registration (e.g., technician, intern, DEA) authorizes a specific activity or status.
- Poison Prevention Packaging Act (PPPA)
- Requires child-resistant containers for most oral prescription drugs unless the prescriber or patient requests otherwise (a per-prescription or blanket patient waiver).
- Child-resistant packaging exemptions
- Certain drugs (e.g., sublingual nitroglycerin, some inhalers, oral contraceptives in their dispensing packages) are exempt from child-resistant packaging.
- Patient waiver of safety cap
- A patient may request non-child-resistant packaging (a blanket waiver is allowed); a prescriber may waive only on a single-prescription basis.
- HIPAA Privacy Rule
- Protects individually identifiable health information (PHI); permits use/disclosure for treatment, payment, and health-care operations and limits other uses to the minimum necessary.
- Protected health information (PHI)
- Individually identifiable health information held or transmitted by a covered entity, protected under HIPAA.
- Minimum necessary standard
- HIPAA principle of using or disclosing only the least PHI needed to accomplish the purpose.
- Notice of Privacy Practices (NPP)
- A document a pharmacy must provide describing how it uses and discloses PHI and the patient's rights.
- Prescription label requirements
- Typically: pharmacy name/address, serial/Rx number, date, prescriber name, patient name, directions, drug name/strength, and required cautionary statements.
- Manufacturer/repackaged label requirements (FDCA)
- Drug labeling must include adequate directions for use, ingredients, lot number, expiration date, and required warnings under the FDCA.
- Federal record retention (non-controlled)
- Federal law focuses on 2 years for controlled records; non-controlled record retention is largely set by state law (commonly 2–7 years).
- Prescription file separation (federal)
- CII filed separately; CIII–V either separate or readily retrievable; non-controlled in the general file.
- USP <795>
- Standards for non-sterile compounding (e.g., creams, capsules, oral liquids), including beyond-use dating and documentation.
- USP <797>
- Standards for sterile compounding to prevent contamination — air quality, garbing, environmental monitoring, and beyond-use dating.
- USP <800>
- Standards for handling hazardous drugs to protect personnel and the environment, including storage, containment, and PPE.
- Hazardous drug storage
- Per USP <800>, hazardous drugs are stored separately, in a negative-pressure, externally vented area (refrigerated HDs in a dedicated negative-pressure refrigerator).
- Compounding vs manufacturing
- Compounding prepares a drug for a specific patient based on a prescriber relationship; manufacturing produces drugs for general distribution and requires FDA registration.
- 503A vs 503B
- 503A = traditional patient-specific compounding pharmacies; 503B = outsourcing facilities that compound in bulk under FDA cGMP oversight.
- Central fill pharmacy
- A pharmacy that fills/refills prescriptions on behalf of another pharmacy under a contractual or common-ownership arrangement, with records linking both.
- Drug Supply Chain Security Act (DSCSA)
- Establishes an electronic, interoperable system to trace prescription drugs through the supply chain to protect against counterfeit/diverted products.
- Transaction history / verification (DSCSA)
- Trading partners must capture product tracing information and verify suspect/illegitimate product, quarantining and investigating as required.
- Federal Food, Drug, and Cosmetic Act (FDCA)
- The foundational FDA law governing drug safety, efficacy, labeling, adulteration, and misbranding.
- Adulteration
- A drug is adulterated if it is contaminated, prepared/held under unsanitary conditions, or fails to meet purity/strength standards.
- Misbranding
- A drug is misbranded if its labeling is false or misleading, lacks required information, or lacks adequate directions for use.
- Legend drug (Rx-only)
- A prescription drug bearing “Rx only”; under the FDCA it may be dispensed only on a valid prescription.
- OTC drug
- A drug that meets FDA monograph standards and may be sold without a prescription with appropriate Drug Facts labeling.
- Behind-the-counter (BTC)
- Products kept behind the counter and sold without a prescription but with pharmacist involvement or record (e.g., pseudoephedrine under CMEA).
- Expired-drug control
- Pharmacies must remove expired/deteriorated drugs from active stock; controlled stock for destruction is documented (Form 41).
- Recall recordkeeping
- Document recall notices, quarantined stock, and actions taken so the response is traceable on inspection.
- PDMP
- Prescription Drug Monitoring Program — a state database tracking dispensed controlled substances; many states require querying it before dispensing certain drugs.
- PDMP reporting
- Pharmacies report dispensed controlled-substance data to the state PDMP within the timeframe set by state law.
- Security of controlled stock
- Controlled substances must be stored in a securely locked, substantially constructed cabinet OR dispersed throughout non-controlled stock to deter theft.
- Wholesaler verification
- A pharmacy may only purchase controlled substances from a DEA-registered distributor, using Form 222/CSOS for Schedule II.
- Returns of dispensed drugs
- Dispensed prescription drugs generally cannot be returned to stock once they leave the pharmacy, except in limited settings (e.g., some long-term-care unit-dose).
- Prescription serial/number system
- Each filled prescription receives a unique identifying number, recorded on the label and in the pharmacy record for traceability.
- Computer/manual recordkeeping requirement
- Pharmacies must maintain accurate records (electronic or paper) of dispensing and inventory that are readily retrievable for inspection.
- Hazardous-drug spill kit
- USP <800> requires accessible spill kits and trained personnel to contain and clean hazardous-drug spills.
- Temperature monitoring
- Refrigerated and frozen drugs (incl. many vaccines) must be stored within labeled ranges with documented temperature monitoring.
- Repackaging/relabeling
- When repackaging into a different container, the pharmacy must preserve required labeling, lot number, and a beyond-use date per USP.
- Schedule II oral emergency quantity
- Limited to the amount adequate to treat the patient during the emergency period only.
- Who may sign DEA Form 222
- The person who signed the most recent DEA registration application, or a person holding a valid power of attorney from that registrant.
- Lost/damaged Form 222
- If a Form 222 is lost or unusable, the executed copies are kept and the error is documented; CSOS avoids paper-form errors entirely.
- Schedule II prescription quantity limit (federal)
- Federal law sets no maximum quantity for a CII prescription, but it must reflect legitimate medical need; states may impose day-supply limits.
- Refill record (controlled)
- Each refill of a CIII–V drug must be documented (date, quantity, dispenser) on the back of the prescription or in an equivalent electronic record.
- Central fill of controlled substances
- Permitted between pharmacies under DEA rules, with records identifying which pharmacy did the filling and which received the drug.
- Schedule designation example — fentanyl
- Fentanyl is a Schedule II controlled substance.
- Schedule designation example — alprazolam
- Alprazolam (Xanax) is a Schedule IV controlled substance.
- Schedule designation example — buprenorphine
- Buprenorphine products are Schedule III controlled substances.
- Schedule designation example — codeine cough syrup
- Limited-quantity codeine cough preparations are Schedule V.
- Triplicate / multiple-copy state forms
- Some states require special serialized prescription forms for controlled substances in addition to federal rules.
- Mailing controlled substances
- Controlled substances may be mailed under USPS rules in plain packaging with no markings indicating the contents.
- DEA inspection (Form 82 / ADIE)
- Inspectors may request an Administrative Inspection Warrant; a registrant can also consent to inspection of records and premises.
- Schedule II label — no refills
- A CII prescription label must not indicate refills; none are permitted.
- Brand medically necessary
- A handwritten or e-prescribed indication by the prescriber that overrides generic substitution for a Medicaid prescription.
- Counseling for mail-order/refills
- OBRA-90's offer-to-counsel applies to new prescriptions; many states extend counseling rights to refills and mail order via written information.
- Patient package insert (PPI)
- Required for certain drugs (e.g., oral contraceptives, estrogens) to be dispensed to the patient with each fill.
- Medication guide (MedGuide)
- FDA-required patient information for certain drugs with serious risks; must be provided when the drug is dispensed.
- REMS
- Risk Evaluation and Mitigation Strategy — an FDA-required safety program for certain high-risk drugs (e.g., clozapine, isotretinoin) that may include pharmacy certification.
- Isotretinoin / iPLEDGE
- A REMS program requiring registration and pregnancy-test verification before dispensing isotretinoin.
- Veterinary prescription
- A veterinarian may prescribe within the scope of veterinary practice; the pharmacist verifies authority and labels accordingly.
- Optometrist prescribing
- Optometrists may prescribe drugs for eye conditions within their state-defined scope.
- Dentist prescribing
- Dentists may prescribe drugs related to dental care within their scope and DEA authority.
- Transfer of non-controlled refills
- Non-controlled prescription refills may generally be transferred between pharmacies without the one-time limit that applies to controlled drugs.
- Patient's right to refuse generic
- A patient may insist on the brand even when substitution is otherwise allowed; cost may then fall to the patient.
- Prescriber verification of new prescriber
- When a prescriber is unfamiliar, the pharmacist confirms licensure and DEA authority before filling controlled prescriptions.
- Adequate directions for use
- A legend drug is exempt from the FDCA's 'adequate directions for layperson' requirement because it is dispensed on a prescription with professional directions.
- Out-of-state prescription
- A pharmacist may fill a valid out-of-state prescription if it meets that prescriber's authority and the dispensing state's rules (controlled-drug rules still apply).
- Pharmacy intern hours
- States require a set number of supervised internship/experiential hours for licensure (commonly ~1,500 hours).
- Foreign pharmacy graduate (FPGEC)
- Foreign graduates typically must obtain FPGEC certification (incl. FPGEE and English proficiency) before licensure eligibility.
- Score transfer (NABP)
- A NAPLEX/UMPJE score may be transferred to additional jurisdictions through NABP for a per-jurisdiction fee; the state's law exam may still be required.
- Continuing-education topics
- Some CE hours may be required in specific subjects (e.g., law, patient safety, opioids) as set by the state board.
- Pharmacist license display
- A current license/registration generally must be displayed or available at the practice site.
- Tech-check-tech (TCT)
- Some boards permit a trained technician to verify another technician's product filling under board-approved programs, usually for unit-dose/inpatient settings.
- Authentication of authority (PIC)
- The pharmacist-in-charge ensures the pharmacy's policies, recordkeeping, and personnel comply with applicable law.
- Change-of-PIC notification
- A change in the pharmacist-in-charge usually must be reported to the board within a set time and may require a closing inventory.
- Reinstatement after lapse
- A lapsed license is reinstated by application, payment of fees, and meeting CE/competency requirements set by the board.
- NDC number
- National Drug Code — a unique 3-segment identifier (labeler–product–package) the FDA assigns to a drug product.
- Tamper-resistant packaging (OTC)
- Required for most OTC products so consumers can detect if a package has been opened or altered.
- Expiration date vs beyond-use date
- An expiration date is set by the manufacturer for the original container; a beyond-use date is assigned by the pharmacy for a repackaged or compounded product.
- Drug shortage management
- Pharmacies may use FDA shortage resources and, where lawful, compounding to address documented shortages.
- Investigational drugs
- Investigational drugs are handled under FDA IND rules and institutional protocols, with controlled distribution and recordkeeping.
- Prescription drug advertising
- The FDA (not the pharmacy) regulates prescription drug advertising for accuracy and fair balance under the FDCA.
- Repackaging into compliance packaging
- Adherence (blister/bingo) packaging must retain required labeling and an appropriate beyond-use date.
- Pharmacy security after hours
- Controlled substances must remain secured (locked storage or dispersal) and the prescription department secured when no pharmacist is on duty.
- Schedule III–V estimate threshold
- During inventory, CIII–V may be estimated unless a container holds more than 1,000 dosage units, which must be counted exactly.
- Records readily retrievable for inspection
- All required pharmacy records must be produced for board or DEA inspection during normal business hours.
- Hazardous-drug receiving (USP 800)
- Hazardous drugs are received and unpacked in a neutral/negative-pressure area away from sterile compounding and using appropriate PPE.
- Sterile compounding garbing order (USP 797)
- Garb is donned dirtiest-to-cleanest (shoe covers, head/facial hair, mask, then hand hygiene and gown, then sterile gloves in the buffer area).
- Patient record confidentiality
- Pharmacy records are confidential under HIPAA and state law; disclosure is limited to permitted purposes and the minimum necessary.
- Disposal of non-controlled drugs
- Non-controlled drug disposal follows EPA/state environmental rules; many drugs cannot be flushed and use take-back or hazardous-waste streams.