Regulatory Round-Up: June 2026

Keeping up with regulatory changes across the US pharmaceutical supply chain is no small task. Between all 50 states, Washington D.C., and Puerto Rico, the volume of rules, regulations, legislation, and proposals that can affect your licenses and operations is constant and easy to miss.

LighthouseAI monitors regulatory activity across every jurisdiction, so you don't have to.

Below is a selection of recent announcements from state regulatory agencies that could impact your organization. LighthouseAI software clients receive Selective Notifications covering these updates and more, delivered directly to keep them current and compliant.

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide From the503B Bulks List

The United States Food and Drug Administration (FDA)announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list.

The 503B bulks list identifies bulk drug substances that outsourcing facilities may use for compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In general, outsourcing facilities may not compound drugs from bulk drug substances unless the substance appears on this list or the compounded drug is on the FDA drug shortage list at the time of compounding, distribution, and dispensing.

After reviewing nominations for these substances, the FDA determined that it did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, or liraglutide from bulk drug substances. The agency stated that determinations of clinical need are based on patient safety and medical necessity under the law. The FDA emphasized that when FDA-approved drugs are available, compounding from bulk drug substances is not permitted without a clear clinical need.

The FDA is inviting public comment and will consider submitted feedback before making a final determination.

Comment Deadline: June 29, 2026

Link for More Information:

• https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list

Alabama Fee Increases

Alabama introduced fee increases in April 2026 for Drug Manufacturers, Wholesale Distributors, Private Label Distributors, Repackagers, Third-Party Logistics Providers, Outsourcing Facilities, Reverse Distributors, Retail Medical Oxygen Suppliers, and Designated Representatives.

As of 4/13/2025, Alabama’s new fees are in effect. They are as follows:

• Initial Fee Resident Pharmacy or resident pharmacy services permit $250
• Initial Fee Nonresident pharmacy or nonresident pharmacy services permit $1000
• Renewal: Resident Pharmacy or resident pharmacy services permit $200
• Renewal Nonresident pharmacy or nonresident pharmacy services permit $350
• Initial fee for annual permit for drug manufacturer, wholesale distributor, private label distributor, repackager, third party logistics provider, outsourcing facility, or reverse distributor$1500
• Retail medical oxygen $400
• Renewal fee for drug manufacturer, wholesale distributor, private label distributor, repackager, third party logistics provider, outsourcing facility, or reverse distributor $1000
• Medical oxygen $250
• Designated Representative fee increased to $250

Link for More Information:

• https://albop.com/statutes-rules/
• Scroll down to 12/17/25 December 680-x-2-.23 to find this information

Massachusetts Pharmaceutical Code of Conduct disclosure report due July 1

The Massachusetts Pharmaceutical Code of Conduct disclosure report is due July 1^st.

Manufacturers(Traditional or Virtual) of Human Rx drugs or medical devices (professional or patient use must submit a disclosure report (covering Jan 1 – Dec 31) to the MA Department of Public Health detailing all payments made to covered recipients. The disclosure report must include activity for an entire calendar year.

A covered recipient is anyone or any organization that is in a position to decide which prescription drugs and medical devices are:

• Prescribed and dispensed to patients,
• Purchased for patients, e.g., in a hospital or nursing home
• Recommended for use by a patient as part of a course of Treatment or treatment plan,
• Purchased as a diagnostic tool or therapeutic equipment,
• Covered by an insurance provider for subscribers to or participants in a health plan,
• A covered recipient could be an individual, such as a: Doctor, Dentist, Pharmacist, Nurse practitioner, Audiologist, Podiatrist, Physical therapist.

A covered recipient is also the person or persons who decide what prescription drugs or medical devices an employer will allow as part of that company's employee health benefit plan. Massachusetts-licensed practitioners are covered recipients, regardless of whether they are actively practicing or where they practice. A covered recipient could be a facility or program, such as a hospital, nursing home, clinic, hospice program, clinical laboratory, home health agency, or pharmacy.

Link for More Information:

• https://www.mass.gov/info-details/pharmaceutical-code-of-conduct-requirements

FDA Product-Specific Guidances for Generic Drug Development

The U.S. Food and Drug Administration (FDA), through the Center for Drug Evaluation and Research (CDER), maintains a publicly available database of Product-Specific Guidances (PSGs) for generic drug development. These guidances describe FDA’s current thinking and scientific expectations for demonstrating bioequivalence and pharmaceutical equivalence between a proposed generic drug product and its reference listed drug (RLD).

PSGs are intended to assist applicants preparing Abbreviated New Drug Applications (ANDAs) by identifying recommended study designs, testing methodologies, and data considerations appropriate for specific drug products. The guidances support compliance with bioequivalence requirements under Title21 of the Code of Federal Regulations (21 CFR) Part 320 and are published incrementally by active ingredient.

FDA uses several factors to prioritize PSG development, including stakeholder requests, drug availability concerns, public health priorities, and outcomes of ongoing Generic Drug User Fee Amendments (GDUFA)research. The Agency also aligns PSG issuance with performance goals established under the GDUFA III commitment framework, particularly for complex products and products containing new chemical entities.

The PSG database is updated as new guidances are issued or existing guidances are revised and serves as a key regulatory resource for generic drug manufacturers and developers.

The Agency is seeking feedback and considers comments to the docket on these guidance at any time. Submit electronic comments to DocketFDA-2007-D-0369.  For further information on submitting electronic comments, refer to (http://www.regulations.gov). You may also mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852. All submissions received must include the Docket No.[FDA-2007-D-0369]. Please contact the Regulations.gov Help Desk at1-877-378-5457 (toll free) or at (http://www.regulations.gov/support) for assistance regarding submissions.

Link for More Information:

• https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm

Stay Ahead of Regulatory Change with LighthouseAI

With regulatory activity constantly evolving across all 50 states and additional jurisdictions, manually tracking every rule, regulation, and legislative change that affects your licenses isn't realistic and gaps in awareness can mean fines, suspended shipments, or disciplinary action.

LighthouseAI monitors all US jurisdictions and sends automated notifications tailored for your business. No noise. No manual research. Just the updates that matter to you, with enough time to act.

What you don't know can hurt you. LighthouseAI will make sure you know. Contact us to learn more.