DelawareSB 180153rd General Assembly (2024–2026)SenateWALLET

AN ACT TO AMEND CHAPTER 25, TITLE 24 OF THE DELAWARE CODE RELATING TO THE BOARD OF PHARMACY.

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Bill Overview

Analyzed Economic Effects

24 provisions identified: 9 benefits, 7 costs, 8 mixed.

Pharmacists face revised discipline and penalties

The act takes effect one year after enactment. Pharmacist discipline now focuses on current conditions that impair judgment or safe practice, rather than drug use during the past 2 years. Breaking the Board’s Code of Ethics is also a ground for discipline. Maximum penalties are $10,000 for a first violation and $50,000 for each later violation; license revocation is permanent. The Board must provide notice and a chance to be heard before limiting a license or practice.

Pharmacists can provide HIV prevention medicine

Beginning one year after enactment, pharmacists can start, dispense, or administer HIV prevention medicines under a statewide public health protocol. They must complete Board-approved training within the year before first providing these services. PrEP, which prevents HIV before exposure, is limited to a 30- to 60-day supply. It requires a negative FDA-approved HIV test from the past 7 days and symptom and medication checks. PEP, which prevents HIV after exposure, requires screening showing exposure within the past 72 hours. Required testing, counseling, referrals, and records apply; new patients cannot skip consultation.

Patients lose pharmacist service payment protection

Beginning one year after enactment, health plans no longer face this specific rule against denying payment for licensed pharmacist services. The removed rule applied when plans covered the same service from a doctor, advanced practice nurse, or physician assistant. Patients' coverage and out-of-pocket costs depend on their health plan; the law sets no dollar amount.

Pharmacists get renewal and return-to-work rules

Pharmacist licenses renew every 2 years with a fee and continuing education, which the Board may randomly audit. A lapse longer than 1 year but shorter than 4 years requires a late fee, education, fingerprints, and disciplinary-history review. A lapse longer than 4 years also requires passing the multistate pharmacy-law exam again. Pharmacists can request inactive status for up to 4 years; returning requires notice, education, a renewal fee, fingerprints, and disciplinary-history review. Failure to reactivate within 4 years requires reapplication and passing the pharmacy-law exam again.

Revised licensing rules for Delaware pharmacists

Pharmacist applicants must meet education, internship, conduct, and fitness standards and pass national and pharmacy-law exams. Foreign-educated applicants must meet Board education rules; foreign graduates seeking reciprocal licenses must also pass the foreign-graduate certification exam. Pharmacists licensed elsewhere must meet good-standing standards in every jurisdiction where they are or were licensed. Reciprocal applicants must pay application and required fingerprint-based background-check fees. The law removes the former express bar for a pending disciplinary case or unresolved complaint.

Patients get deadlines for pharmacy records

Patients must receive requested pharmacy records as soon as reasonably possible, no later than 15 business days. Records must be provided immediately when an emergency or medical condition requires them. Pharmacies can use nonpaper records and provide records in formats other than paper. Prescription and dispensing records must be kept at least 3 years and remain available for Board inspection. Confidentiality rules still apply.

Patients get drug information and flexible prescriptions

Licensed practitioners can issue lawful prescriptions in writing, verbally, electronically, or by fax, with details required by Board rules. Pharmacy containers must carry labels with Board-required information, replacing the statute’s fixed list. Practitioners dispensing directly must provide a label or document with the patient’s full name and address, dispensing date, and practitioner contact details. It must list the drug’s name, strength, form, quantity or stop date, renewals, directions, and route when nonoral. Controlled-drug information must also include the practitioner’s federal drug-enforcement registration number.

Patients can get emergency medicine refills

Beginning one year after enactment, pharmacists can provide patients an emergency supply of a noncontrolled drug. The Board of Pharmacy sets the requirements for these supplies. The law does not state a supply amount, exact qualifying situations, or patient price.

Pet owners gain another prescription seller

Board-registered businesses that are not pharmacies can sell noncontrolled prescription drugs designated for veterinary use. A licensed veterinarian must authorize the sale by written, electronic, fax, or verbal order. Verbal orders must be put in writing.

Pharmacy students gain supervised practice options

Pharmacy interns and students in approved college practical-experience programs can perform functions allowed by Board rules. A licensed pharmacist must directly supervise them and remain in the licensed establishment containing the pharmacy department. The supervising pharmacist is responsible for support staff’s work.

Compounded drugs must meet safety standards

All drug compounding must meet applicable United States Pharmacopeia standards. The definition covers specified preparation based on prescriptions or practitioner requests, including advance preparation based on routine prescribing patterns. It also covers research, teaching, and chemical analysis, but excludes preparation for sale or dispensing. Practitioners retain their existing authority to order compounded medication for use in their practices.

Pharmacy Board puts public safety first

The Board must put public protection first, including protection from unsafe practices, reduced competition, and price fixing. It can set pharmacy recordkeeping, drug-monitoring, and operating standards and inspect pharmacies for violations. Authorized officials can seize harmful drugs or materials, including drugs posing an immediate public-health danger. When the Board finds unlicensed pharmacy practice or use of the pharmacist title, it must request Attorney General action. Board rules must follow Delaware’s rulemaking process and remain consistent with the law’s public-protection requirements.

Non-drug businesses shed pharmacy licensing rules

Beginning one year after enactment, these pharmacy supervision and licensing requirements cover drugs rather than non-drug personal-care products. Businesses making, packing, packaging, or distributing non-drug toiletries, tooth-care products, or cosmetics no longer face these particular requirements. This change does not remove rules for products that are drugs.

Drug establishments face new licensing checks

Covered drug establishments need qualified supervision, suitable key personnel, fingerprint-based state and federal checks, paid fees, and separate licenses for each location. They must meet regulatory-history requirements and keep licenses available for inspection. Manufacturers and outsourcing facilities must submit ownership details and acceptable recent manufacturing inspection reports; outsourcing facilities also need federal registration and a Board wholesaler license first. Wholesalers must submit ownership details, floor plans, a lease or deed, and an FDA regulatory letter; medical gas dispensers must submit ownership details and floor plans. Applicable home-state licensing proof is required, and establishment licenses end upon any ownership change, legal dissolution, or discontinued operations.

Medical gas sellers keep records longer

Registered Delaware businesses selling prescription medicinal gases must keep order records onsite for at least 3 years, up from 2. Sales require a licensed practitioner’s written, electronic, fax, or verbal order; verbal orders must be put in writing. Storage and dispensing must follow Board requirements.

Out-of-state pharmacies face licensing and penalties

Out-of-state pharmacies need a Delaware license before providing prescription drugs to anyone in the state by any delivery method. Applicants must pay a fee, provide sworn compliance evidence and pharmacy-department plans, and meet good-standing, regulatory-history, and inspection requirements. An eligible alternative inspection report is allowed when the home-state authority has not completed a qualifying inspection. Violations can bring probation, suspension, permanent revocation, or penalties up to $250,000 per violation and per continuing day. These monetary caps replace the former $50-per-day maximum.

Pharmacy businesses face major violation penalties

Pharmacies and pharmaceutical establishments can face reprimands, probation, suspension, permanent license revocation, and monetary penalties. Maximum penalties are $250,000 per violation and $250,000 for each day a violation continues. After a hearing, pharmacy discipline can follow legal violations, regulatory discipline, licensing fraud, or refusal of inspection or records access. Closing a prescription department for more than 14 consecutive days is also a ground unless the Board finds reasonable cause. Establishments also face discipline for key personnel’s substantially related crimes or regulatory discipline.

Unlicensed out-of-state pharmacies face higher fines

Beginning one year after enactment, operators of out-of-state pharmacies face higher fines for delivering prescription drugs into Delaware without a Delaware license. The maximum fine rises from $50 to $10,000 for each day the offense occurs or continues.

Pharmacies must clear licensing before opening

The Board reviews applications and issues licenses to qualifying pharmacies and establishments, replacing its prior permit authority. Pharmacies must apply, pay the required fee, provide sworn compliance evidence, and pass inspection before opening. Each pharmacy must have a licensed pharmacist in charge who manages only that pharmacy, required equipment and references, and notice about reporting unresolved medication errors. The law ends temporary 90-day pharmacy licenses and the former option for one 90-day extension while permanent applications are pending.

Drug substitutions come with patient safeguards

Pharmacists can replace brand-name drugs with therapeutically equivalent drugs when the prescriber authorizes substitution. Written forms must include “Substitution Permitted” and space to handwrite “Brand Necessary” or “Brand Medically Necessary.” Biological substitutes require FDA designation as interchangeable or therapeutically equivalent and no prescriber prohibition. Pharmacists must tell patients and identify the maker on prescriptions and labels unless the prescriber directs otherwise; biological product details must reach prescribers within 10 days, except for hospital pharmacies, unchanged refills, or when no qualifying substitute exists. Unauthorized substitution carries a $500–$1,000 fine, 30 days to 1 year in prison, or both.

Pharmacy applicants face registration and background checks

Beginning one year after enactment, pharmacy students must apply for intern registration after entering their first professional year at an accredited school. Applications require class-standing and preceptor statements; foreign-educated applicants must meet Board education rules. Intern applicants must meet conduct and fitness standards, including requirements concerning administrative penalties. A pharmacy-related conviction or pending charge bars registration unless Board review finds a waiver poses no unreasonable public-safety risk. Applicants covered by the license requirements must provide fingerprints for state and federal background checks and pay required fees. Applicants with no criminal record must submit no-record statements from both agencies; fee amounts are not stated.

Pharmacy Board drops specific oversight duties

The law removes the Board’s specific duty to keep a drug-outlet registry and monitor those outlets for safe practices. It also removes the Board’s express subpoena power in this law for witnesses, books, and papers. Pharmaceutical-establishment inspections still follow pharmacy inspection rules, but extra coverage for toiletries, tooth products, and cosmetics is removed. Other applicable oversight requirements remain.

Out-of-state pharmacies face fewer service rules

Beginning one year after enactment, licensed out-of-state pharmacies no longer report the previously specified corporate officers and dispensing pharmacists. They no longer must offer pharmacist phone service at least 6 days and 40 hours weekly. They also no longer must print that number on each prescription container. Shipments not personally hand-delivered to the patient must include written notice of a local or toll-free phone service staffed by a registered pharmacist.

Pharmacy closings and layouts follow Board rules

Temporary and permanent pharmacy closings must follow Board rules. The law removes fixed advance notices: 14 days for permanent closings and 5 days for temporary closings exceeding 7 business days. Pharmacy licenses automatically end when ownership changes, legal existence ends, or business or professional practice stops. Prescription departments also follow Board rules instead of fixed statutory room, counter, locking, and pharmacist-sign requirements.

Sponsors & Cosponsors

Sponsor

Nicole Poore
Democratic • Senate

Cosponsors

Darius J. Brown
Democratic • Senate
Eric Buckson
Republican • Senate
Daniel Cruce
Democratic • Senate
Stephanie L. Hansen
Democratic • Senate
Gerald W. Hocker
Republican • Senate
Kyra L. Hoffner
Democratic • Senate
Russell Huxtable
Democratic • Senate
Kamela T Smith
Democratic • House
Dave G. Lawson
Republican • Senate
S. Elizabeth Lockman
Democratic • Senate
Spiros Mantzavinos
Democratic • Senate
Trey Paradee
Democratic • Senate
Brian Pettyjohn
Republican • Senate
Marie Pinkney
Democratic • Senate
Bryant L. Richardson
Republican • Senate
Ray Seigfried
Democratic • Senate
David P. Sokola
Democratic • Senate
Laura V. Sturgeon
Democratic • Senate
Bryan Townsend
Democratic • Senate
John "Jack" Walsh
Democratic • Senate
David L. Wilson
Republican • Senate

Roll Call Votes

All Roll Calls

Yes: 61 • No: 0

House vote • 6/30/2025

Passed (SM required)

Yes: 40 • No: 0

Senate vote • 6/26/2025