Which States Have the Tightest Regulations on Compounded Medications?

In 2012, contaminated drugs compounded by a Massachusetts pharmacy led to over “750 cases of infection and more than 60 deaths of patients in 20 states.”

This outbreak not only led to the Drug Quality and Security Act (DQSA), but it also encouraged states to tighten their rules governing drug compounding.

LookMeds identified six metrics that reflect stricter rules and gathered information on all 50 states’ regulations to determine which states have the tightest regulations on compounded medications.

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Top States with the Tightest Regulations on Compounded Medications

Below, we explore what rules earned each state a place in the top ten.

1. California

Regulating Entity: The California State Board of Pharmacy

Storage Rules

In addition to federal storage laws, California requires that reusable supplies, those not used in the primary engineering control (PEC), cannot be stored within 1 meter of the PEC.

Ingredient Rules

Compounding pharmacies are required to purchase their active pharmaceutical ingredient (API) and excipient components from an “FDA-registered facility, be accompanied by a Certificate of Analysis (COA).”

Limited Amount Rules

For compounded sterile preparations (CPS), California only allows for a limited quantity to be made and stored before receiving a patient-specific prescription. Additionally, the facility can only make and store an amount “necessary to ensure continuity of care for identified patients based on a documented history of prescriptions for that patient population.”

In a situation when a patient may experience intense suffering or their life is at risk, and direct and immediate administration is needed, then a facility can compound the medication. However, they can only make enough to help the patient and no more.

Facilities must document the CSP, the date and time, the number of units compounded, the patient’s name and unique identifier, as well as the circumstances causing the patient to need immediate aid.

Pharmacist Health Rules

Before any personnel is allowed into the compounding area, California requires the supervising pharmacist to check for “rashes, recent tattoos or oozing sores, conjunctivitis, active respiratory infection, or any other medical condition, to determine if such condition could contaminate [the combination] or the environment.”

If the supervising pharmacist determines that any of these “contaminating conditions” are present, then the personnel are not allowed to enter the compounding area.

Container Rules

In addition to all federal container laws, California specifically mentions that single-dose containers that are entered or punctured outside of an “ISO Class 5 area” must be discarded immediately.

Any single-dose container entered or punctured inside the area must be properly thrown away within 12 hours.

Prescription Rules

A facility must have received a patient-specific prescription document to compound a CSP or a compounded nonsterile preparations (CNSP). If facilities regularly receive these prescriptions, they can prepare the compound in advance, but only in the necessary quantities.

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2. Georgia

Regulating Entity: The Georgia State Board of Pharmacy

Storage Rules

In addition to federal regulations and storing equipment and utensils used for compounding in a manner that protects them from contamination, anything stored must be immediately inspected before being used in compounding.

Ingredient Rules

All components, drug preparation containers, and closures used to compound drugs must be rotated so that the oldest stock is used first.

Limited Amount Rules

Compounding pharmacies cannot distribute non-patient-specific compounded medication for office use. This rule does not apply to veterinarians.

However, the distribution of compounded preparations to a veterinarian cannot exceed “5% of production of compounded preparation in a calendar year by that pharmacy.” If pharmacies produce more than 5%, it’s considered manufacturing, which requires a separate license.

Pharmacist Health Rules

Any person who has an apparent illness or open lesion that may negatively affect the safety or quality of the drug being compounded may not have “direct contact with components, drug preparation containers, closures, in-process materials, and drug preparations” until they’re better.
Anyone who assists the pharmacist in compounding must report any health conditions that might compromise the drug preparations.

Container Rules

If a component is moved from its original container to another, the new container must be clean and include the component name and weight or measurement.

Additionally, the prep containers and closers must not be “reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the compounded drug beyond the desired result.”

Prep containers and closures intended for sterile compounding preparations must be handled, sterilized, processed, and stored in a way that removes pyrogenic properties.

Prescription Rules

Pharmacists may prepare compounded medications before receiving a valid prescription based on a history of receiving that valid prescription. These prescriptions must be properly labeled.

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3. Alabama

Regulating Entity: The Alabama State Board of Pharmacy

Storage Rules

Multi-dose containers must be stored in accordance with federal laws and receive a beyond-use-date (BUD) of 28 days once entered unless otherwise specified by the manufacturer.

If entered/opened in an ISO 5 environment, single-dose containers should have a BUD of 6 hours. If they’re in an environment less than ISO 5, the BUD should be 1 hour.

Ampules cannot be saved or stored, as they are always single-use. Additionally, preserved solutions lose their 28-day BUD if removed from the original container and placed in a syringe or other container.

Ingredient Rules

Facilities must first try to get ingredients from an FDA-registered facility, and the containers should have the batch control number and expiration date. When compounding ingredients cannot be obtained from such a facility, they must be purchased from reliable sources, stored according to the manufacturer’s or USP standards, and made of the appropriate identity, purity, and quality.

If ingredients cannot be obtained through these standards, then the pharmacist in charge must certify them through independent analysis.

Container Rules

Containers and closures used for drug products should be both handled and stored to prevent contamination while also allowing for inspection and cleaning of the work area. The containers and closers must be made of a material that doesn’t alter the quality, strength, or purity of the compounded drug.

Additionally, if the component is transferred from the original container to another, the new container must include the component name and supplier, the lot number and expiration date, and the strength and concentration (if available).

Prescription Rules

Pharmacies must have a prescription to compound drugs. When the facility anticipates receiving valid prescriptions, products can be prepared in advance in reasonable amounts.

The drugs must be stored within the prescription departments and not sold in bulk to other pharmacies or vendors for resale.

However, if the pharmacy is compounding a product using all over-the-counter ingredients, a prescription is not required, but it does need to be made for a specific person.

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4. Idaho

Regulating Entity: The Idaho Board of Pharmacy of the Division of Occupational and Professional Licenses

Storage Rules

Idaho requires that opened or partially used packages of ingredients that will be used later on must be stored as follows:

• If opened in non-sterile conditions, opened or entered single-dose containers (e.g., bags, bottles, syringes, etc.) must be used within one hour; any remaining contents must be discarded.
• Single-dose vials needle-punctured in a sterile environment, however, can be used for up to six hours after initial puncture.
• Open single-dose ampoules can’t be stored for any time period.
• Multiple-dose containers may be used for up to 28 days, as long as they’re made to be used multiple times and if it does not go against manufacturer labels.

Ingredient Rules

All active pharmaceutical ingredients must be purchased from an FDA-registered manufacturer.

Additionally, the strength of the active ingredient must not vary from the labeled potency more than what’s listed as the drug’s product potency range by the USP-NF monograph. If the USP-NF does not have a published range, then Idaho requires the active ingredients to be not less than “ninety percent (90%) and not more than one hundred ten percent (110%) of the potency stated on the label.”

Limited Amount Rules
Idaho has what they call a “triad relationship.” This means that if a pharmacist has a valid prescription and an established “prescriber/patient/pharmacist relationship,” they can compound a product according to that prescription.

Commercially available drug products may be compounded, but they can’t be made regularly or in inordinate amounts and only (1) if it’s medically needed to provide an alternate ingredient, dosage form, or strength and (2) if the commercial product is not reasonably available to meet the patient’s needs in time.

Finally, if a pharmacy has a history of receiving valid prescription orders, they can—in limited quantities—compound the drug orders beforehand.

Prescription Rules

Relating to the rules above, a pharmacist needs to have a valid prescription and an established relationship with the prescriber/patient/pharmacist to make the compound. When the pharmacist has a history of receiving the drug order, they can prepare the compound in advance. 

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5. New Hampshire

Regulating Entity: The New Hampshire Board of Pharmacy

Storage Rules

New Hampshire requires that storage shelving in buffer and ante areas be fully emptied, cleaned, and sanitized at planned intervals at least monthly.

The state also requires that low-risk compounding products be stored for no more than 48 hours at room temperature, 14 days at cold temperatures, or 45 days when frozen (if the product's stability allows it).

Medium-risk compounds shall not exceed 24 hours at room temperature, 3 days at cold temperatures, or 45 days being frozen.

High-risk compounds shall not be stored for more than 24 hours at room temperature, 3 days at cold temperatures, and 45 days in a frozen state.

Ingredient Rules

New Hampshire requires pharmacies to source their ingredients from the United States Pharmacopeia (USP), National Formulary (NF), or Food Chemicals Codex (FCC).

However, if ingredients must be purchased from a non-FDA-registered facility, the compounder should use their professional judgment to select acceptable and reliable ingredients. The compounder must establish purity and safety and obtain a certificate of analysis from the manufacturer or a qualified third party.

When a sterile product is unavailable commercially, the compounder must only use “USP or other USP recognized grades such as BP, JP, EP bulk ingredients” and obtain them from a supplier that follows good manufacturing practices.

Limited Amount Rules

A pharmacist can offer a compounded drug to a practitioner to help an individual patient, but only in limited quantities. These products are for practitioner administration only and can’t be re-dispensed.

Additionally, when there’s a commercial drug shortage, and the manufacturer of that drug cannot supply it to the public or practitioners, then a pharmacist can compound a limited quantity using the active pharmaceutical ingredient. They can then sell the compound to a patient with a valid prescription from a valid prescriber.

This compound cannot be for resale.

Prescription Rules

If a pharmacist has a valid prescription from a valid prescriber, they can compound and sell a limited quantity of the needed drug using the active pharmaceutical ingredient.

When the product is sold to a medical office or practice, it must only be used to administer to patients and not for resale.

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6. New Mexico

Regulating Entity: The New Mexico Board of Pharmacy

Ingredient Rules

New Mexico requires outsourcing facilities to purchase ingredients from suppliers that comply with the USP-NF monograph standards. If the facilities cannot purchase from such suppliers, they must find another compendium or pharmacopeia recognized by the FDA.

Limited Amount Rules

A resident pharmacy must limit the amount of compounded sterile human drug preparation it sells interstate to 5% of the total prescriptions it dispenses unless it is registered with the FDA and the board as an outsourcing facility.

Container Rules

When containers allow for individual units of a drug to be removed for dispensing or administration, the container shall include:

1. A list of active and inactive ingredients (identified by established name) and the quantity or proportion of each ingredient.
2. Any other required information that facilitates “adverse event reporting in accordance with the requirements established in Section 310.305 of title 21 of the Code of Federal Regulations (CFR).”

Prescription Rules

An outsourcing facility cannot dispense drugs to someone before receiving a prescription unless it is also a licensed pharmacy (or nonresident pharmacy). The facility must be registered in the state and meet all applicable federal and state requirements.

The facility must maintain the required records of the outsourcing facility separately from those required for the pharmacy.

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7. Arizona

Regulating Entity: The Arizona State Board of Pharmacy

Storage Rules

In addition to federal regulations, Arizona requires that components, pharmaceutical product containers, and closures be stored off the floor and in a way that prevents contamination.

Additionally, stored items must be rotated so the oldest approved stock is used first.

Ingredient Rules

Compounding pharmacies are allowed access to active pharmaceutical ingredients to compound a drug to help chronically and terminally ill patients as long as the ingredients meet the United States pharmacopeia monographs, which are as follows:

• An FDA-approved supplier makes the active pharmaceutical ingredient.
• Ingredients are shipped in compliance with state law and arrive with a certificate of analysis detailing quality specifications, such as
  • Medications
  • Dietary supplements
  • Amino acids that are already in use by compounding pharmacies in Arizona

However, if the active ingredient is considered unfit for compounding by the FDA or is placed on the interim 503A category II bulk drug substance list, compounding facilities cannot access it.

Pharmacist Health Rules

Arizona requires that all personnel inform the pharmacist-in-charge of any health condition that may adversely affect a compounded product.

Prescription Rules 

A pharmacist must have a valid prescription to compound a product. If the pharmacist wishes to compound more of the product prior to receiving the prescription, they must first establish a history of receiving valid prescriptions for the compounded products.

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8. Colorado

Regulating Entity: The Colorado State Board of Pharmacy

Storage Rules

Personnel must monitor the storage area daily. If a CSP is exposed to temperatures either below or above its limits, a designated person(s) must determine whether it is still usable (i.e., retains its integrity and quality). If the person cannot determine this, the product must be discarded.

Limited Amount Rules

Colorado states that no non-controlled substance preparation can be compounded in advance if the quantity exceeds a 90-day supply or whatever amount is necessary to accurately compound the product.

A 90-day supply is determined by the average number of dosage units dispensed or distributed of the preparation during the previous six months.

Prescription Rules

If a patient needs an altered version of a commercially available drug (e.g., removal of a dye that causes an allergic reaction, etc.) and a practitioner sends a compounding pharmacy a valid prescription, then a pharmacist may create the needed compound.

A pharmacist may also compound a commercially available drug if the compounded drug is significantly different from the commercially available product. If this is done for a patient, the patient must be informed that the drug is compounded.

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9. Massachusetts

Regulating Entity: The Massachusetts Board of Pharmacy

Ingredient Rules

Massachusetts does consider adding flavoring agents to conventionally manufactured non-sterile drug products as compounding.

Container Rules

Pharmacies can only use commercially available sterile, depyrogenated containers and container-closure systems.

Prescription Rules

A pharmacist must have patient-specific prescriptions to dispense any compounded preparation into, within, or from Massachusetts.

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10. Missouri

Regulating Entity: The Missouri Board of Pharmacy

Storage Rules

Facilities must store food and beverages that aren’t in their original, sealed packaging in an area separate from medication and related devices. Additionally, open food and beverages used in compounding or intended for patient use with the medication can be stored in the same area as drugs as long as the items are separated from other inventory and sanitary conditions are maintained at all times.

Any and all outdated, distressed, misbranded, or adulterated drugs must be physically separated from active inventory and maintained in a separate area.

Also, medication and confidential pharmacy records can be stored in an off-site location/address if it’s registered with the Board.

Limited Amount Rules 

Medication can be compounded in limited quantities before receiving a valid prescription if there is a history of receiving and filling those prescriptions, assuming an established relationship between the pharmacist, patient, and prescriber.

Missouri defines a “limited quantity” as a three-month supply of a batched product or as a one-year supply of compounded preparations intended for external use (e.g., creams, ointments, lotions, etc.). However, a prescription is required to dispense any pre-prepared product.

Prescription Rules

Unless otherwise stated by law, pharmacies can only dispense compounded preparations after receiving a valid prescription or medication order.

These compounded preparations cannot be offered to “pharmacies, practitioners or commercial entities for office use or for subsequent resale.” However, a compounded preparation can be dispensed for a prescriber to administer in the prescriber’s office as long as a valid prescription or medication order has been received for the individual patient.

Regardless of the type of product, compounding may only be done by prescription/medication order.

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See how many points every state earned.

Note: States with zero points require their compounding facilities to meet federal and USP laws, which were not considered in scoring.

Methodology

To determine which states have the tightest regulations on compounded medications, LookMeds studied the publicly available rules and regulations of all 50 states.

To keep the data simple, LookMeds identified six key metrics against which to measure each state’s rules. These metrics included specific storage requirements, specific ingredient rules, limited production rules, specific mention of pharmacist health, container rules, and prescription laws.

Since laws are less quantifiable, we selected a point-based scoring system to create our rankings. States earned a point for each rule pertaining to these key metrics. The more points a state earned, the tighter the regulations.

Storage Regulations

We looked for storage requirements beyond those listed in federal regulations and the United States Pharmacopeia (USP) chapters 797 and 795.

States that mentioned additional storage requirements earned a point for this category.

Ingredient Regulations

Almost all states require compounding facilities to use quality ingredients. States with laws that built upon or clarified those found in USP chapters 797 and 795 and federal guidelines earned a point.

Limited Production

States that limited compounding preparations to a certain quantity and specified that quantity earned a point.

Pharmacist Health

States that specifically mentioned pharmacist health and responsibilities beyond basic federal requirements scored a point for this category.

Container Regulations

If states had rules about containers (e.g., how they’re handled, changed, or rotated), they received an additional point.

Prescription Laws

States with laws requiring a valid prescription before compounding and dispensing medications and other preparations earned a point.

How does this affect getting weight loss medication?

States with tighter regulations may affect how easy it is to obtain weight loss medications or other compounded drugs.

• Access to Medications: States with tighter restrictions may limit the availability of compounded medications, making them harder for individuals to obtain. This might cause people to seek alternative options, like out-of-state pharmacies or FDA-approved alternatives.
• Quality Assurance: Stricter laws often lead to higher quality products and safety standards, meaning individuals in states with tighter regulations may benefit from better-compounded medications; however, it can also affect how easy it is to obtain medications. Some people might turn to less-regulated sources, which can be unsafe if the seller does not follow necessary safety precautions.
• Legal and Prescription Challenges: Patients living in states with tighter regulations might encounter stricter requirements to get a prescription, like needing additional documentation or a thorough consultation with a healthcare provider.
• Awareness and Decision-Making: When you understand the regulatory landscape of your state, you can make informed decisions about where to source medications and what safe alternatives might be.

All states require compounding pharmacies to meet a certain level of safety and quality to ensure their products are safe for human consumption and do what they are meant to. 

However, some facilities are not FDA-approved and do not follow these standards. It’s vital that you ensure whatever supplier you purchase compounded medications from has your best interest in mind and is not selling potentially harmful or ineffective products.

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Bottom Line

Some states simply require compounding facilities to comply with federal and USP laws, while others are more intentional about how compounding pharmacies operate.

Understanding state regulations is important for those seeking safe and effective medications, including weight loss treatments. While stricter rules can ensure a safer and higher-quality product, they may also create additional challenges in accessing these medications.

LookMeds is here to simplify your journey. We ensure all our products meet state and federal regulations while making it easy to access compounded weight loss medications. Our licensed pharmacists work with you and tailor the medication to meet your needs. Visit our website or sign up for a telehealth consultation to learn how LookMeds can help you.

Fair Use Statement

Please feel free to share our rankings if you found them insightful. However, please provide a link back to this report so readers can access our full methodology.

_{Disclaimer: Conclusions are based on chosen key metrics and publicly available information. Some states have limited access to their compounding rules. Those seeking compounded medications should consult a trusted healthcare provider before making major decisions.}

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