Mid-Atlantic Health Law TOPICS

IV hydration businesses are popping up in major cities across the country, including here in Maryland. Most hydration businesses offer a variety of products to their customers, including infusions of vitamins and other elements promoted to improve health or reduce stress. Since these businesses are relatively new, they remain largely unregulated. 

However, recent guidance from the Food and Drug Administration (FDA) makes it clear that IV hydration businesses need to be aware that some of their activities may be considered to involve the “compounding” of drugs, and thereby require the businesses to comply with a web of federal and state laws and regulations.

FDA

The FDA applies certain sanitary and manufacturing requirements to the compounding of drugs. The FDA stated in an October 2021 article that “Drugs” and “Drug products” include IV hydration products and IV vitamins. While not defined in the law, the FDA has consistently stated in guidance that: compounding is the practice in which “ingredients of a drug are combined, mixed, or altered to create a medication tailored to the medical needs of an individual patient”; and adding vitamins to an intravenous solution bag is compounding.

The FDA requires all drugs, including compounded drugs, to meet certain good manufacturing practice standards, labeling requirements, and to be approved by the FDA as a new drug. However, Section 503A 
of the Food and Drug Act exempts from these requirements certain compound drug products that meet certain requirements (FDA Exemption), including:

1. A drug product that is compounded for an identified individual based on a valid prescription order of a prescribing practitioner, and the compounding is performed by a licensed pharmacist in a licensed pharmacy or a licensed physician; or
2. A drug product that is compounded by a licensed pharmacist or physician and done in limited quantities before receiving a valid prescription but based on a history of receiving valid prescriptions such that a relationship is established between the licensed pharmacist/physician and the individual patient or ordering practitioner. 

Certain other requirements also apply to limit the substances that may be used even in an exempt compounding. 

Therefore, if IV hydration businesses are compounding drugs (for example, adding vitamins to IV solutions) without using a physician or pharmacist to do the compounding,  then these businesses are not exempt from the good manufacturing practice requirements, labeling requirements, and FDA approval process for the compounded drug.

 United States Pharmacopeia 797

Even if the IV hydration compounding fits into the FDA Exemption, the compounding must still comply with the USP 797 guidelines for sterile preparations.

The USP 797 guidelines, with changes effective November 1, 2023, establish requirements for compounded sterile preparations (CSPs) which include personnel training and testing, personal hygiene and garbing requirements, facilities and engineering controls including air flow and cleaning, certification, monitoring, equipment and supplies standards, and record keeping requirements. 

The guidelines, however, exempt from most of the requirements “Immediate-Use CSPs” and “Preparation Per Approved Labeling”. 

Immediate-Use CSPs must meet certain requirements, including policies and procedures and staff training, and be for the direct and immediate administration to a patient, including being administered to the patient within four (4) hours of the preparation. If the CSPs meet this exception, then the IV hydration business may not have to comply with the more onerous USP 797 standards, though it will still have to fit into the FDA Exemption.

The exception for Preparation Per Approved Labeling requires that any mixing, reconstituting, or other such acts are performed in accordance with directions contained in approved labeling or supplemental materials provided by the product’s manufacturer and the product is prepared as a single dose for an individual patient and the approved labeling contains information for the diluent, the resultant strength, the container closure system, and storage time. 

Any mixing of drugs that meets this exception would not be considered compounding. This means that if an IV hydration business purchases its IV cocktails from a manufacturer whose products meet the preceding requirements, the IV hydration business does not need to meet the additional USP 797 requirements nor fit into the FDA Exemption.

Maryland State Law

State laws on compounding drugs also impact the regulatory landscape that IV hydration businesses must navigate. In Maryland, there is some confusion regarding how the various state licensing boards will interpret and enforce these State laws. 

Maryland law defines the practice of pharmacy as including “compounding” prescription and nonprescription drugs and devices. The law defines “compounding” to mean “the preparation, mixing, assembling, packing, or labeling of a drug or device[.]” 

On July 19, 2023, the Board of Pharmacy at its Board meeting stated “[i]ntroducing vitamins into a sterile intravenous solution bag constitutes compounding. As such, compounding performed by a pharmacist must occur in accordance with USP <797> (under a hood and in a sterile environment). Please contact the respective health boards for standards relating to compounding by other healthcare practitioners.”  

However, Maryland regulations governing the practice of nursing also state that a nurse may “[a]dd medications to an intravenous solution” subject to specific education and training requirements. The nursing regulations do not state anything about compliance with USP 797. 

Neither the Board of Nursing nor the Board of Pharmacy have issued any clarifying guidance on how these two state laws interact.

Conclusion

IV hydration businesses should be aware that, unless the intravenous solution products they purchase from manufacturers come premixed, or are labeled sufficiently with instructions on mixing and meet the USP 797 Preparation Per Approved Labeling exception, a physician or a pharmacist must be engaged to perform the compounding in compliance with the FDA Exemption standards, or the IV hydration business will need to meet the much higher FDA standards for non-exempt compounding, which is likely unrealistic for these new, often small, start-up businesses. 

There is also some uncertainty at the State level as to whether nurses who add medications to intravenous solutions are compounding under State law and are required to comply with USP 797 as are compounding pharmacists in Maryland. Accordingly, licensed practitioners may want to reach out to their respective 
licensing boards to request clarification on how their board regulates the act of compounding for IV hydration.
 

Darci M. Smith
410-576-4153 • dsmith@gfrlaw.com