MPJE key terms

The principal federal statute governing drug safety, effectiveness, labeling, and manufacturing. It authorizes FDA oversight and sets requirements pharmacies must meet when dispensing, repackaging, or distributing drugs.

1951 amendment to the federal Food, Drug, and Cosmetic Act that created the prescription-only drug category and required the legend "Caution: Federal law prohibits dispensing without a prescription" on such drugs.

An FDA-required safety program for certain drugs; it may require prescriber training, patient enrollment, or restricted distribution, and pharmacies sometimes need certification before they can dispense.

The FDA's program for reporting serious adverse events, product quality defects, and medication errors. Reporting by pharmacists is generally voluntary and submitted on Form 3500 or 3500B.

Federal law requiring an interoperable electronic system to trace prescription drugs through the supply chain, using transaction information, product identifiers, and verification of trading partners.

Federal law requiring child-resistant packaging for most oral prescription drugs and some over-the-counter products, with exemptions when the prescriber or the patient requests easier-to-open packaging.

Federal regulation limiting use and disclosure of protected health information by covered entities such as pharmacies; it permits disclosures for treatment, payment, and operations and requires safeguards and patient notice.

Federal law imposing daily and monthly purchase limits, photo-identification logbook entries, and behind-the-counter storage rules on ephedrine and pseudoephedrine products sold without a prescription.

Behavior that violates accepted pharmacy practice standards, such as dispensing without a valid prescription, practicing while impaired, or falsifying records; it is grounds for board discipline.

A state-operated database that collects dispensing data for controlled substances; pharmacists report each dispensing and must review the database in the circumstances their state law specifies.

Federal statute that places drugs into five schedules by abuse potential and medical use, and sets registration, ordering, security, inventory, and prescription rules enforced by DEA.

Controlled substances with high abuse potential, severe dependence liability, and accepted medical use; they require a written or electronic prescription, allow no refills, and carry stricter storage and recordkeeping duties.

Required federal registration for practitioners and pharmacies that handle controlled substances; it is site-specific, renewed every three years, and must be updated when the address or ownership changes.

The order form used to obtain Schedule I and II controlled substances from a supplier; purchaser and supplier each retain copies, and electronic ordering may replace the paper form.

DEA-approved electronic ordering that replaces the paper Form 222 for Schedule I and II drugs, using digital certificates and electronic signatures to authenticate each order.

The DEA form documenting destruction or surrender of controlled substances; the registrant records the drug, quantity, and witnesses, and must also follow applicable state destruction rules.

Report of Theft or Loss used to notify DEA of stolen or significantly lost controlled substances; the registrant keeps a copy, and state authorities may require separate notice.

A complete count of all controlled substances on hand, taken at least every two years; Schedule II drugs are counted exactly, while others may be estimated unless a container holds more than 1,000 units.

Written authorization by which a DEA registrant lets an employee sign controlled substance order forms; the document is kept on file with the executed order forms.

The pharmacist's legal duty to judge that a controlled substance prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

A circumstance suggesting a controlled substance prescription may be invalid, such as a long-distance prescriber, cash payment, early refills, or unusual patterns; it must be resolved before dispensing.

Dispensing less than the prescribed quantity; for Schedule II the remainder is generally supplied within 72 hours, or within 60 days when the patient is in long-term care or terminally ill.

A Schedule II drug may be dispensed on an oral order in a genuine emergency, limited to the emergency period, if the prescriber delivers a written prescription within seven days.

Federal limit on Schedule III through V prescriptions: they may not be filled or refilled more than six months after the issue date and may be refilled no more than five times.

Electronic prescribing of controlled substances under DEA rules, requiring identity proofing, two-factor authentication, and pharmacy verification of the prescriber's digital signature and records.

Information that must appear on a dispensed outpatient prescription label, including pharmacy name and address, prescription number, date, patient name, directions for use, prescriber, and required cautionary statements.

Federal Medicaid law requiring pharmacists to offer counseling on new prescriptions and to perform prospective drug review; most states have extended the counseling duty to all patients.

Review of a prescription before dispensing to identify therapeutic duplication, drug interactions, contraindications, wrong dose, or abuse, with the pharmacist resolving problems before the drug is released.

FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, listing products rated therapeutically equivalent; pharmacists use these ratings when selecting generic substitutes permitted by state law.

The pharmacist designated as responsible for a pharmacy's day-to-day compliance with drug laws and board rules, including recordkeeping, security, and supervision of pharmacy personnel.

Obtaining a license in a new state based on an existing license in good standing and required examination scores, subject to that state's eligibility, fee, and jurisprudence requirements.

Approved education hours a licensee must complete during each renewal cycle, often including mandated topics such as pharmacy law, opioid prescribing, or patient safety.

Board-issued credential allowing a technician to assist in pharmacy practice under pharmacist supervision; requirements typically include training, criminal background checks, and periodic renewal.

United States Pharmacopeia chapter setting standards for nonsterile compounding, covering facility design, equipment, personnel training, master formulation records, and assignment of beyond-use dates.

Chapter establishing standards for sterile compounding, including cleanroom classifications, environmental monitoring, gowning, personnel qualification, and validation of sterilization and aseptic technique.

Chapter on safe handling of hazardous drugs, covering containment and ventilation, closed system transfer devices, personal protective equipment, deactivation and cleaning, and worker medical surveillance.

A state-licensed pharmacy or physician that compounds for identified individual patients under a valid prescription and meets conditions that exempt it from certain federal manufacturing requirements.

An entity that compounds sterile drugs, may ship without patient-specific prescriptions, must register with FDA, follow current good manufacturing practice, and report the products it makes.

The date after which a compounded preparation may no longer be used; it is assigned from USP standards based on water content, storage conditions, and container type.

Nonprescription products kept behind the counter rather than on open shelves; they may require pharmacist assistance, age verification, or recordkeeping but legally do not need a prescription.