Peptide rules by state: how pharmacy boards differ

Federal law sets the outer limits for compounded drugs, including peptides. But state boards of pharmacy do most of the day-to-day oversight of state-licensed pharmacies ^{[1, 2]}. So the rules a pharmacy must follow depend on where it is, where it ships, and which board licenses it. This page explains the main ways states differ, with examples from state laws ^{[5, 6, 8, 9]}.

Federal law first

Under section 503A, a pharmacy may compound for an identified patient based on a valid prescription, using bulk ingredients that meet federal conditions ^{[3, 4]}. FDA says that wherever compounding happens, other federal law still applies, including the rules on insanitary conditions ^[1]. Our pages on 503A vs 503B pharmacies and compounded vs FDA-approved drugs cover the federal rules. The FDA Peptide Status Tracker shows the federal status of each peptide ^[4].

FDA says states are primarily responsible for daily oversight of the vast majority of the thousands of compounders in the U.S., most of which do not register with FDA ^[2]. State officials are often the first to spot compounders with poor practices ^[2].

Difference 1: licensing pharmacies in other states

A pharmacy that ships into another state may need a license or registration there too. States set their own rules for these nonresident pharmacies ^{[7, 8]}.

Florida law treats any pharmacy outside the state that ships a dispensed drug into Florida as a nonresident pharmacy. It must register with the Florida board and hold a valid license in its home state ^[8]. It must also offer a toll-free line to a pharmacist at least 6 days and 40 hours a week, and print that number on each label ^[8].

California goes further for sterile products. A nonresident pharmacy may not compound sterile drugs for shipment into California without a California sterile compounding license ^[7]. The license must be renewed every year, and the board must inspect the location before it is issued or renewed ^[7].

Difference 2: sterile compounding standards

States also set their own rules for pharmacies that compound sterile drug products. Some tie those rules to the national standard for sterile compounding, United States Pharmacopeia (USP) General Chapter 797 ^[6].

California requires any pharmacy that compounds sterile drug products to hold a separate sterile compounding license ^[6]. Its board must review any formal revision to USP Chapter 797 within 90 days to decide whether its own rules need to change ^[6].

Texas law says a pharmacy may not compound and dispense a sterile preparation unless it holds the license the board requires ^[5]. A Texas pharmacy that compounds sterile preparations must tell the board right away about adverse effects it learns of. It must also tell the board within 24 hours after it issues a recall ^[5].

Difference 3: office-use compounding

Office use means a pharmacy supplies a compounded drug to a prescriber's office for use on patients there, without a prescription for a named patient ^{[4, 5]}. Federal law ties 503A compounding to patient-specific prescriptions, while 503B outsourcing facilities may fill orders for office stock ^[4].

State laws on office use are not the same. Texas law says a pharmacy may dispense and deliver a reasonable quantity of a compounded drug to a practitioner for office use ^[5]. To do so, the pharmacy must verify the source of its raw materials, follow applicable USP guidelines including testing, and follow board rules on adverse event reporting and recalls ^[5]. A state rule like this does not change the federal 503A conditions, which still apply ^{[1, 3]}.

Difference 4: telehealth prescribing

FDA notes that some people get compounded drugs through online pharmacies and telehealth platforms ^[1]. State laws set the rules for telehealth prescribing, and they vary ^{[9, 10]}.

Florida lets a health care professional licensed in another state treat patients in Florida by telehealth if the professional registers with the Florida board ^[9]. The professional must hold an active, unencumbered license and have no discipline in the prior 5 years ^[9]. Florida also says a telehealth provider may do a patient evaluation by telehealth, and must meet the same professional standard of practice as in-person care in Florida ^[9].

California says prescribing dangerous drugs without an appropriate prior examination and a medical indication is unprofessional conduct ^[10]. It allows that exam to be done by telehealth, including a self-screening tool or questionnaire, if the standard of care is met ^[10].

Difference 5: shipping limits and the FDA agreement

Federal law links interstate shipping to a memorandum of understanding (MOU) between FDA and each state ^[3]. In a state without an MOU, a 503A pharmacy's out-of-state shipments may not exceed 5 percent of its total prescription orders ^[3].

FDA offered a standard MOU to states in October 2020 ^[2]. After a lawsuit, a federal court sent the MOU back to FDA in September 2021. FDA says it intends to use notice-and-comment rulemaking on these provisions, including the MOU ^[2].

What this means

A pharmacy's state license, its sterile compounding permit, and the licenses it holds in each state it ships to all shape what it may do ^{[5, 7, 8]}. Each state board is the place to check its own rules ^{[1, 2]}.

Frequently asked questions

Who regulates compounding pharmacies, the state or FDA?

Both. State boards of pharmacy oversee most state-licensed pharmacies day to day. FDA mainly oversees 503B outsourcing facilities ^[1].

Can a pharmacy ship compounded drugs to another state?

Often yes, but the receiving state may require a license or registration. Florida, for example, requires nonresident pharmacies to register with its board ^[8].

Do states have their own sterile compounding licenses?

Some do. California requires a sterile compounding license, and nonresident pharmacies need one to ship sterile drugs into California ^{[6, 7]}.

What is office-use compounding?

It is compounding for a prescriber's office instead of a named patient. Texas allows a reasonable quantity for office use under set conditions ^[5].

Can a doctor in another state prescribe by telehealth?

It depends on the state. Florida lets out-of-state professionals treat Florida patients by telehealth if they register with the Florida board ^[9].

Is there a federal limit on shipping compounded drugs across state lines?

The law sets a 5 percent limit in states without an FDA agreement, but a court sent FDA's standard agreement back in 2021 and FDA plans new rulemaking ^{[2, 3]}.