AL MPJE cheat sheet

The federal Controlled Substances Act (21 U.S.C. §801 et seq.) and 21 CFR Parts 1300–1321 classify drugs into Schedules I–V; Alabama adopts the same five schedules and adds state-level entries, notably gabapentin as a Schedule V substance.

The Alabama Pharmacy Practice Act is codified at Code of Alabama Title 34, Chapter 23; implementing regulations appear in the Alabama Administrative Code, Chapter 680-X.

The Alabama Board of Pharmacy licenses pharmacists, permits pharmacies, registers technicians, and enforces the Practice Act; its rules are adopted under the Alabama Administrative Procedure Act.

The Durham-Humphrey Amendment created the prescription-only "legend" category: a drug that cannot be used safely without professional supervision requires a prescription, and it authorized oral prescriptions and refills.

The federal Combat Methamphetamine Epidemic Act limits retail ephedrine/pseudoephedrine sales to 3.6 g per purchaser per day and 9 g per 30 days, requires photo ID, a written or electronic logbook, and behind-the-counter storage.

Alabama requires a separate Alabama Controlled Substances Certificate (ACSC), distinct from the DEA registration, for practitioners who prescribe, administer, or dispense controlled substances; it is issued by the practitioner's own licensing board.

Under the Drug Supply Chain Security Act, pharmacies may trade prescription drugs only with authorized trading partners and must retain transaction information and transaction statements.

FDA-approved labeling with adequate directions for use is a federal requirement; Alabama labeling rules layer additional state-mandated elements onto that base.

Alabama pharmacist licensure requires graduation from an ACPE-accredited pharmacy program, passage of NAPLEX and the Alabama MPJE, and completion of Board-specified internship hours.

Licensure by transfer uses NABP's electronic license transfer service, but the candidate must still satisfy Alabama's MPJE, experience, and continuing education requirements.

Each pharmacy location must hold its own Alabama pharmacy permit; relocation or change of ownership requires Board notification and a new or amended permit.

Every permitted pharmacy must designate a pharmacist-in-charge who is accountable for compliance, records, security, and daily operations.

Pharmacy technicians must register with the Alabama Board of Pharmacy and may practice only under the supervision of a licensed pharmacist.

Alabama requires ACPE-accredited continuing education each renewal cycle, including Board-specified hours such as pharmacy law; certificates must be retained and are subject to audit.

Scope of practice includes dispensing, compounding, patient counseling, immunization administration under protocol, naloxone dispensing under a standing order, and drug therapy management activities authorized by Board rule.

A pharmacist may dispense naloxone without a prescription under Alabama's statewide standing order/protocol and must provide overdose education with the product.

A valid prescription must contain the patient's name and address, drug name, strength, dosage form, quantity, directions for use, date of issue, and the prescriber's written or electronic signature.

A controlled substance prescription must include the prescriber's DEA registration number; Schedule II prescriptions may not be refilled.

Federal law caps Schedule III–V prescriptions at five refills, and the prescription expires six months after the date of issue.

An oral emergency Schedule II order may be dispensed, but the prescriber must deliver a written or electronic prescription within seven days.

Required label elements: pharmacy name and address, prescription number, date filled, patient name, directions, prescriber name, drug name/strength/quantity, beyond-use or expiration date, and the dispensing pharmacist's initials.

Auxiliary warning labels are required where appropriate (e.g., may cause drowsiness, take with food, shake well, external use only) under Board rule and USP standards.

Counseling must be offered on every new prescription and whenever the pharmacist judges it necessary; a refusal must be documented, and counseling may occur by telephone when the patient is not present.

Generic substitution is permitted unless the prescriber indicates dispense-as-written or brand medically necessary; the substitution and manufacturer must be recorded and the patient informed.

Schedule I substances have no currently accepted medical use and a high abuse potential and are not dispensed by pharmacies; Schedules II–V have accepted medical uses with decreasing abuse potential.

Schedule II substances are purchased with DEA Form 222 or through CSOS; Schedule III–V purchases are documented on invoices that must be retained as records.

A controlled substance inventory is taken every two years: exact count required for Schedule II; an estimated count is allowed for Schedule III–V containers holding 1,000 units or less.

Theft or significant loss must be reported to DEA on Form 106 within one business day of discovery, with notice to local police and the state Board.

A Schedule II prescription may be partially filled, with the remainder supplied within 72 hours; for long-term care residents or terminally ill patients the remainder may be supplied within 60 days.

The Alabama PDMP is maintained by the Alabama Department of Public Health; dispensers must report controlled substance dispensing, and gabapentin is reportable because Alabama places it in Schedule V.

Authorized pharmacists may query the PDMP for patient care; unauthorized disclosure or use of PDMP data is prohibited and subject to discipline.

Naloxone may be dispensed without a prescription under Alabama's standing order, and statutory immunity protects prescribers, dispensers, and lay rescuers acting in good faith.

Controlled substance records - biennial inventories, Form 222/CSOS records, invoices, and prescriptions - must be kept for two years and be readily retrievable for inspection.

Schedule II prescription records must be maintained separately from other prescription records or be readily retrievable from the pharmacy's system.

Expired or unwanted controlled substances are returned to a DEA-registered reverse distributor or destroyed on site using DEA Form 41 with a witness signature.

A controlled substance inventory record must show the date, the time taken (opening or closing of business), the signature of the person who took it, and whether the count was exact or estimated.

Under DSCSA, suspect or illegitimate product must be quarantined, investigated, and reported to the manufacturer and FDA as required.

Recalled stock must be removed from active inventory immediately and documented; patients must be notified when a recall requires retrieval or follow-up of dispensed product.

Alabama Board inspectors may conduct administrative inspections of a permitted pharmacy during business hours, and refusal to permit inspection is grounds for discipline.

Records must be produced in a legible, orderly form on request during an inspection; electronic records must be readily retrievable and printable.

Nonsterile compounding follows USP <795>: default beyond-use dates depend on water content and storage - water-containing oral preparations are limited to 14 days refrigerated, and nonaqueous preparations to 180 days.

Sterile compounding follows USP <797>: the revised chapter uses Category 1 and Category 2 compounded sterile preparations with assigned default beyond-use dates, environmental monitoring, and personnel qualification.

Hazardous drug handling follows USP <800>: negative-pressure buffer rooms with external venting, closed system transfer devices, and documented training and assessment.

Each compounded preparation requires a master formulation record and a compounding record listing ingredients, lot numbers, expiration dates, quantity, beyond-use date, and the identity of the compounder.

Compounding must be pursuant to a patient-specific prescription; anticipatory compounding is limited to small quantities based on a history of receiving valid prescriptions.

Alabama Board rules incorporate USP compounding standards, and failure to comply is grounds for disciplinary action against the permit and the pharmacist.

Sterile compounding personnel must complete initial and periodic evaluation, including garbing observation, gloved fingertip sampling, and media fill testing.

Alabama pharmacists may administer immunizations under a protocol or standing order; federal PREP Act declarations have temporarily expanded authority to children as young as 3 during the covered period.

Vaccine storage: refrigerated vaccines at 2–8 °C (36–46 °F) and frozen vaccines at −50 to −15 °C, with temperatures logged at least twice daily and excursions documented.

Immunizations administered must be reported to ImmPRINT, Alabama's statewide immunization registry.

Clinically significant adverse events following vaccination must be reported to the federal Vaccine Adverse Event Reporting System (VAERS).

Immunization protocols must be signed by the authorizing prescriber or medical director and reviewed on the schedule the Board requires.

Alabama pharmacists may dispense naloxone under a standing order and must provide overdose response education to the recipient.

Retail sales of ephedrine and pseudoephedrine must comply with the federal Combat Methamphetamine Epidemic Act limits, logbook, and photo identification requirements.

Public health screening services such as blood pressure and glucose testing may be offered only with appropriate training, equipment maintenance, and referral protocols.

A pharmacist must be on duty whenever the pharmacy is open; the prescription department must be enclosed and locked when no pharmacist is present.

A documented continuous quality improvement program should capture dispensing errors and near misses, identify root causes, and track corrective actions.

Temperature-sensitive inventory requires monitored refrigeration with logs and written procedures for handling excursions.

Technician ratio and permitted duties are set by Board rule; technicians may not perform final verification of a prescription or provide patient counseling.

Automated dispensing devices require role-based access controls, accuracy checks, and periodic inventory reconciliation.

Look-alike/sound-alike medications should be stored apart and flagged with Tall Man lettering and auxiliary alerts to reduce selection errors.

All pharmacy personnel must have documented training and competency records appropriate to their duties.

Patient information is protected by HIPAA and Alabama confidentiality law; prescription records may be accessed only by authorized personnel for legitimate purposes.