Recent legislative and regulatory activity at the state level reflects a growing effort to more closely regulate drug compounding through statutory and rule-based controls. Several measures introduced or implemented in late 2025 and early 2026 would narrow the circumstances under which compounded drugs may be prepared or distributed, expand documentation and recordkeeping obligations, and, in some cases, extend pharmacy oversight to clinical settings that administer compounded drugs.
There are three recent state actions of significance:
- Florida’s Senate Bill 860 (SB 860) and House Bill 877 (HB 877) would impose active pharmaceutical ingredient (API)-based sourcing and documentation conditions on the distribution of certain compounded drugs, if enacted.
- California adopted Board of Pharmacy rules redefining “essentially a copy” and assigning pharmacists an affirmative duty to verify and document patient-specific “clinically significant differences.”
- Indiana’s Senate Bill 282 (SB 282) would tighten bulk drug substance compounding, expand oversight and recordkeeping, and regulate medical spas through a new registration and enforcement regime.
In addition, federal legislation introduced in the U.S. Congress in December 2025 would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to significantly narrow the scope of lawful compounding and impose new reporting, inspection, and fee obligations on both 503A pharmacies and 503B outsourcing facilities.
Florida: Senate Bill 860 and House Bill 877
Florida’s recently introduced SB 860 seeks to specifically regulate compounded drugs for weight loss.[1] The bill defines “compounded medication” under state law and prohibits the sale, transfer, or distribution of compounded weight-loss drugs unless the pharmacy or practitioner complies with specified requirements and submits documentation to the Department of Business and Professional Regulation certifying compliance. Those requirements include using an API identical to that used in an FDA-approved drug and manufactured using the same process, and sourcing the API from an FDA-registered facility inspected within the preceding two years with satisfactory results. The requirements also include ensuring the API is pharmaceutical-grade and conducting independent quality-control testing to verify identity, strength, and impurity profile before use.
In a parallel bill, Florida’s HB 877 would impose broad state-law controls on the sale, transfer, and distribution of certain compounded drugs by conditioning lawful activity on compliance with specified APIs and documentation requirements.[2] Like SB 860, HB 877 reflects a policy shift toward using state law to regulate compounded drug supply chains.
Florida’s SB 860 was filed on December 10, 2025, and subsequently referred to the Senate Regulated Industries and Appropriations committees, where it remains pending further committee action. HB 877 was filed on December 23, 2025, and subsequently referred to committee on January 5, 2026.
California: “Clinically Significant Difference” Standard and New Pharmacist Duty
California finalized new regulations that took effect October 1, 2025, and continue to be implemented into 2026. These rules, applicable to both nonsterile and sterile compounding under distinct provisions, define a compounded drug as “essentially a copy” of a commercially available product if it contains the same API, unless a change is made for an identified individual patient that produces a “clinically significant difference” for that patient, “as verified and documented by the pharmacist.”[3]
Unlike federal law, these state requirements for both sterile and non-sterile compounding create and impose an affirmative obligation on the pharmacist to verify and document that such a clinically significant difference exists.[4] So even where federal standards are satisfied, by a prescriber determining that a change for an identified patient produces a significant difference, [5]the California Board of Pharmacy may independently evaluate whether the pharmacist has adequately verified and documented a clinically significant difference and may take enforcement action if the Board determines that the pharmacist’s verification or documentation is insufficient.
While this rule is presently being enforced, the Board has not issued formal guidance or publicly articulated criteria defining what constitutes sufficient evidence of a “clinically significant difference.” As a result, enforcement remains fact-specific and discretionary. As noted previously by Frier Levitt, it is important for pharmacies licensed in California and dispensing compounded products to California patients to take additional steps to ensure compliance with these new requirements.[6]
Indiana Senate Bill 282 (Bulk Drug Substance Restrictions and Medical Spa Registration)
Introduced in January 2026, SB 282 would tighten state controls on drug compounding and create a new registration and enforcement framework for “medical spas.”[7] Effective July 1, 2026, the bill would restrict compounding using bulk drug substances unless specified statutory requirements are met, reflecting a state-level shift toward prescriptive input standards for compounded drugs and expanded documentation obligations for the compounding supply chain.
SB 282 would also impose new recordkeeping and oversight measures. It would require persons who sell, transfer, or distribute compounded drugs to maintain specified records. In addition, the bill would direct the Indiana Department of Health to prepare a recurring report concerning the state’s oversight of drug compounding and the risks posed by compounding.
Beginning January 1, 2027, SB 282 would require medical spas to register with the Indiana Board of Pharmacy, would require the Board to establish and maintain a public database of registered medical spas, and would require each medical spa to designate a responsible person who is physically present for a sufficient time to ensure compliance. The bill would also require medical spas to notify the Board after a serious adverse event and would authorize the Board to take disciplinary action, including suspension of a medical spa registration.
Federal Legislation Seeks to Compound Burdens
On December 9, 2025, Representatives Rudy Yakym (R-IN) and André Carson (D-IN) introduced House of Representatives Bill 6509 (HR 6509), the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act of 2025.[8] The bill, which has been referred to the House Committee on Energy and Commerce, would amend FDCA to impose new statutory restrictions on compounding pharmacies and FDA-registered outsourcing facilities. As written, the SAFE Drugs Act could materially narrow the scope of lawful compounding, displace FDA’s long-standing discretion, and significantly increase cost of compliance for both 503A pharmacies and 503B outsourcing facilities. Critically, the federal proposal arrives amid several state-level regulatory activity.
- Statutory Redefinition of “Essentially a Copy” and a Monthly Prescription Cap
The Bill amends Section 503A to redefine “essentially a copy of a commercially available drug product” to include any compounded drug that contains an active ingredient found in an FDA-approved drug, unless a patient-specific change produces a “significant difference,” as determined by the prescriber.
This expands the definition and replaces FDA’s current guidance-based framework, under which a compounded drug is considered essentially a copy only if it: (1) contains the same active pharmaceutical ingredient(s) as the commercially available drug, (2) has the same, similar, or easily substitutable dosage strength, and (3) is administered by the same route, unless the prescriber determines that a change for an identified individual patient produces a significant difference for that patient.[9]
- New Federal Reporting Obligations for 503A Compounders
HR 6509 further requires pharmacies, facilities, and physicians to report to the Department of Health and Human Services (HHS) when they compound, more than 20 times in a single month for out-of-state patients, any drug product containing an active ingredient found in a commercially available drug, including monthly totals by product type. This would institute a new federal reporting regime for 503A compounders, historically regulated almost exclusively by states.
503A compounders do not register their compounding facilities with FDA, and the agency does not interact with the vast majority of licensed pharmacists and physicians who compound drug products under Section 503A. This is a fundamental structural feature of the 503A framework since its creation in 1997. Section 503A was created in 1997 to accommodate traditional pharmacy compounders with state-level oversight, requiring individual patient-specific prescriptions and production of limited quantities. As a result, the entire regulatory architecture has been state-based for nearly 30 years.
- Also impacts “Large-Scale” 503B Outsourcing Facilities
The bill also defines a “large-scale outsourcing facility” as any 503B facility that “compounds more than 100 times in a single calendar year, any drug product.”[10] For such facilities, the bill requires:
- FDA inspection prior to compounding any drug product for the first time;
- Biennial reinspection (at least once every two years); and
- Removal of the Section 510(g)(1) exemption, subjecting 503B facilities to full establishment registration and drug listing requirements.
HR 6509 also amends Section 744K(c)(1)(A)(i) to eliminate the statutory $15,000 base establishment fee for 503B outsourcing facilities and replace it with “a base amount deemed appropriate by the Secretary” to fund activities related to the safety of compounded drug products. The amendment removes any fixed statutory cap on the base establishment fee and delegates fee-setting authority to HHS.
Key Takeaways and Recommendations
In light of accelerating state-level activity and the potential for heightened federal scrutiny of drug compounding, pharmacies and outsourcing facilities should closely monitor legislative, regulatory, and enforcement developments that may affect compounding practices and distribution models. Proposed and newly effective measures at both the state and federal levels signal increased attention to ingredient sourcing, documentation, recordkeeping, and oversight of downstream clinical settings.
With deep experience in both pharmacy and FDA regulatory law, Frier Levitt attorneys are actively tracking these developments and advising clients on their potential operational and compliance implications. Our team is available to assist with regulatory monitoring, targeted compliance assessments, and strategic planning as this landscape continues to evolve.
[1] S.B. 860, 2026 Leg., Reg. Sess. (Fla. 2026).
[2] H.B. 877, 2026 Leg., Reg. Sess. (Fla. 2026) (introduced version).
[3] 16 CCR § 1735(d) (non-sterile); 16 CCR §1736 (e).
[4] 16 CCR §§ 1735 et seq. (nonsterile) and 1736 et seq. (sterile).
[5] 21 U.S.C. § 503A(b)(2); See Also, Food & Drug Admin., Ctr. for Drug Evaluation & Research, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry (Jan. 2018) at 6.
[6] Jesse C. Dresser, California Board of Pharmacy’s New “Essentially a Copy” Rules: What GLP-1 Compounders Need to Know, Frier Levitt (Aug. 18, 2025)
[7] S.B. 282, 124th Gen. Assemb., 2d Reg. Sess. (Ind. 2026) (introduced Jan. 12, 2026)
[8] Congress, Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act of 2025, CRI2025, GovInfo (Introduced in House 12/09/2025).
[10] Safe Drugs Act, Section 4.
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