Are Your Therapies FDA Compliant?

IV Hydration Clinics: Are Your Therapies FDA Compliant?

IV hydration clinics engage in sterile compounding activities (combining or mixing ingredients to create a custom drug/medicine for an individual patient), such as creating IV vitamin therapies, etc. This act of drug compounding in IV hydration clinics is regulated under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and standards published by the United States Pharmacopeia (USP).

U.S. Food and Drug Administration (FDA) is tasked with enforcing these standards.

Are your IV therapies in compliance with USP standards and Section 503A of the Federal Food, Drug, and Cosmetic Act? Call (713) 909-7323 today to learn how Hendershot Cowart P.C. can help.

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IV Therapies and Section 503A of the FD&C Act

Section 503A is one of two provisions of the Federal Food, Drug, and Cosmetic Act that applies to drug compounding. Drugs, such as IV therapies, that are compounded in accordance with Section 503A are exempted from certain federal requirements.

These exemptions include:

  • Current good manufacturing practice requirements (section 501(a)(2)(B));
  • Labeling with adequate directions for use (section 502 (f)(1)); and
  • Premarket approval requirements (section 505).

To qualify for these exemptions and remain compliant with the FD&C Act, IV therapies must be compounded under certain conditions:

  1. The compounding must be done by either a licensed pharmacist in a state-licensed pharmacy or federal facility, or a licensed physician.
  2. Compounding must be done pursuant to the receipt of a valid prescription for a specific patient. In a physician-office setting, a prescriber may place an order in the patient’s health record.
  3. Further conditions apply including restrictions on batch compounding, compounding commercially available products, and limits on interstate distribution.
  4. Bulk drug substances used in compounding must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with FDA under section 510.

In addition, to qualify for 503A exemptions, bulk drug substances must:

  • Comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding.
  • If a monograph does not exist, the bulk substances must be a component of an FDA-approved drug; or
  • If such a monograph does not exist and the drug substance is not a component of an FDA-approved, the bulk substances must appear on a list of bulk drug substances that can be used in compounding under section 503A developed by FDA through regulations.

In June of 2016, the FDA issued guidance clarifying that to be eligible for the 503A exemptions, a physician engaged in drug compounding must comply with the above regulations, as well as with the applicable USP chapter on pharmacy compounding.

In plain English, the scope and application of this 503A is not limited to whether bulk substances comply with an applicable USP chapter or National Formulary monograph. Physician compounded IV therapies must also be prepared in compliance with USP Chapter 797.

What Are USP Standards for Physician Compounded IV Therapies?

The United States Pharmacopeia (USP) is a scientific nonprofit organization that sets public standards for identity, strength, quality, and purity of medicines. The FDA is responsible for enforcing USP standards recognized by various provisions of the FD&C Act.

USP Chapter 797 provides standards for sterile compounding, including:

  • Supervision of compounding personnel;
  • Training of compounding personnel; and
  • Sanitary conditions for preparation of drug compounds.

USP published proposed revisions to Chapter 797 in September 2021. These proposed revisions state that the requirements of USP 797 should apply to drug compounds used for injections and infusions as well. These proposed revisions will become effective on November 1, 2023.

In summary, IV Hydration clinic therapies must comply with both:

  1. The legal conditions under Section 503A of the FD&C Act; and
  2. The standards set forth under USP Chapter 797.

Can The FDA Investigate my IV Hydration Clinic?

Because unsanitary conditions in compounding facilities can lead to significant and widespread patient harm, the FDA does investigate adverse event reports related to compounding drug facilities.

Adverse reports are investigated by the FDA’s Office of Criminal Investigations (OCI), the law enforcement branch of the FDA. They investigate various issues ranging from fraud to FD&C Act violations. The FDA has recently become more aggressive in investigating FD&C Act violations. However, they will not initiate an investigation unless there has been a complaint or a report of non-compliance.

Complaints of FD&C Act violations can come from a variety of places, including the following:

  • Patients
  • Healthcare professionals
  • Clinics
  • Compounding pharmacies
  • Manufacturers

Once the FDA receives a report, a consumer safety officer will be assigned to research and investigate the incident.

Note: Reporting (including self-reporting) of adverse events is not required under Section 503A.

When conducting investigations and disciplinary reviews, the FDA may collaborate with:

  • Texas Medical Board
  • Texas Board of Nursing
  • Texas State Board of Pharmacy
  • Other state and local health departments.

Consequences of an adverse compliance action could span from seizures and injunctions to civil or criminal prosecution. Your professional license could also be at risk.

Examples of Unsanitary Conditions for Compounding IV Therapies

Cases of drug compounding in unsanitary conditions are well documented, and the FDA has shared the conditions they’ve uncovered in their investigations of these cases.

Here are a few of the unsanitary conditions observed during FDA inspections into adverse events:

  • Contamination in compounding areas including peeling paint, stained work surfaces, visibly dirty equipment, and air vents with dust and grime
  • Difficult to clean equipment and surfaces such as carpeting in the IV storage and mixing room
  • Standing water in a refrigerated storage area used to store sterile vials
  • Use of expired active pharmaceutical ingredients to prepare drug products intended to be sterile
  • Personnel in street clothes with ungloved hands filling drug products intended to be sterile into syringes outside of an ISO-5 classified area
  • Hazardous drugs were handled without providing adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination

Unsanitary conditions observed in compounding facilities can lead to patient illness, infection, septic shock, and even death. Patient safety should always be at the center of your compliance practices.

FDA Compliance Attorneys for IV Hydration Clinics in Texas

At Hendershot Cowart P.C., we understand how difficult it can be to understand FDA regulations, especially those surrounding in-office compounding outside of a licensed pharmacy.

Our attorneys can support your objectives to deliver safe, compliant IV therapies by:

  • Advising on compliance with local, state, and federal regulations related to owning and operating an IV hydration clinic
  • Helping you structure a compliant IV hydration business model
  • Reviewing your clinic’s compounding policies and procedures
  • Responding to warning letters, inspections, and enforcement actions
  • Dealing with FDA investigations into adverse events

When you need knowledgeable guidance on regulatory compliance matters or representation when legal issues arise, we are just a phone call away.

Do you have questions about FDA compliance and IV hydration? Contact Hendershot Cowart P.C. online, or by calling (713) 909-7323 to schedule a consultation.

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