How do healthcare providers care for a sick child who vehemently refuses their medicine due to its bitter taste? Or treat patients with a crucial medication after a leading pharmaceutical company discontinues it? These scenarios underscore the invaluable role of compounding pharmacies. They adjust medications, transforming distasteful flavors to ones a choosy child can tolerate, convert pills into consumable liquids, and ensure the continued availability of treatments no longer mass-produced. Yet, the process of modifying, combining, or altering ingredients to tailor a medication to a patient's specific needs goes beyond following processes that ensure patient safety and medication efficacy. It also includes the challenge of steering through the complexities of compounding pharmacy regulations and labeling requirements.

The Regulatory Landscape for Compounding Pharmacies

This personalized approach to medication comes with a complex set of regulatory requirements. These requirements are designed to ensure that compounded medications are prepared safely and effectively, protecting patients from potential harm. Adhering to regulations from the United States Pharmacopeia (USP), the Accreditation Council for Healthcare (ACHC) and other state and federal regulatory bodies is essential.

For example, USP issues these standards that apply to compounding:

USP General Chapter <797> is a national standard for the process, testing, and verification of any compounded sterile preparations including injectables, eye drops, and parenteral nutrition.
USP General Chapter <795> is similar to USP 797 but guides nonsterile preparations such as oral medications, creams, ointments, and other topical applications. In addition, it defines concepts such as beyond-use dates.
USP General Chapter <800> defines the practice and quality standards of hazardous drugs which can be either non-sterile or sterile and includes drugs that are carcinogenic, teratogenic, or otherwise pose a risk to healthcare workers.

Complying with these standards requires protocols that protect the safety of patients and staff and ensure the efficacy of the medications compounded.

The Critical Role of Labeling

Labeling in compounding pharmacies is not just about identifying the medication. It's a critical component of regulatory compliance and patient safety. Drug labeling provides information such as active ingredients, strength, and beyond-use dates and is an essential step to prevent dosing errors. Labels also aid in the identification, handling, and transportation of hazardous drugs. Implementing effective labeling processes enhances the overall safety of compound medications, for both patients and staff.

Identifying HDs

Determine which drugs are considered hazardous. NIOSH considers a drug hazardous if it exhibits one or more of the following traits:

• Carcinogenicity
• Teratogenicity or other developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity
• Structure and toxicity profiles that mimic existing drugs determined hazardous by the above criteria

Although the official list hasn’t been updated since 2016, this NIOSH list of HDs does include updates proposed in 2020.

Inventory HDs

Once you’ve identified the HDs, segregate the inventory. Typically, the hazardous drug name, its formulation, and whether it is a tablet, capsule, or liquid, should be noted.

Handling and Transporting HDs

When HDs are transported outside of the compounding pharmacy, you must include storage and disposal instructions and HD category information.

In addition, compound medications should include labels that contain the:

• Generic or chemical names of active ingredients
• Strength or quantity of these ingredients
• Pharmacy lot number
• Beyond-use date
• Any special storage requirements

These regulations are designed to ensure that all compounded medications are appropriately identified and used safely.

Clarity and Safety in Labeling

Clear and informative labeling guides proper use for any medication, but it’s even more important when compounding is involved. Although compounded prescription labeling is regulated at a state level, unlike with FDA-approved prescription medications, the regulations vary. This lack of standardization in product labels can lead to dosing errors. In fact, in one prominent case, the FDA found patients were inadvertently overdosed on fentanyl, ketamine, phenylephrine, neostigmine, and succinylcholine because of the difference in labeling practices between conventional manufacturers and compounders. Proper labeling not only aids in regulatory compliance but also ensures that patients and healthcare providers can easily understand the medication's contents and instructions. Labeling that details dosage instructions, potential allergens, storage requirements, and drug and food interactions, minimizes the risk of medication errors and adverse reactions.

Custom Labeling Requirements for Compound Medications

The labeling requirements for compound medications often require some level of customization. In addition to the name of the compounding and/or dispensing pharmacy, each compounded drug must include:

• Name (brand or generic) and strength, volume, or weight of each active ingredient
• Instructions for storage, handling, and administration
• The rate of infusion for admixed IV solutions
• The beyond-use date for the drug preparation
• The date compounded
• The lot number or pharmacy reference number

In addition, HDs require an additional level of labeling. This includes the hazardous drug name and safety labels that meet OSHA and GHS standards when transporting outside of the compounding pharmacy.

United Ad Label specializes in providing custom labeling solutions tailored to the specific needs of compounding pharmacies.

Risk Mitigation

Compliant labeling plays a significant role in mitigating risks associated with compounded medications. By ensuring that all necessary information is accurately, clearly, and consistently presented, pharmacies can significantly reduce the likelihood of medication errors and the associated liability risks. By ensuring that all necessary information is clearly and accurately presented, labels act as a first line of defense in safeguarding patient health.

Best Practices

Implementing effective labeling strategies is essential for maintaining compliance and ensuring the safety of compounded medications. Start by regularly reviewing and updating labeling processes to align with current regulations. Updated USP <797> regulations took effect November 1, 2023. Have you updated your processes to incorporate these new mandates? In addition, choose labels that meet the demands of your specific applications. An improper label material or adhesive can cause the label to fail and disrupt the safety and efficiency of the operation.

Partnering with United Ad Label

The overriding goal of healthcare compliance is to ensure that healthcare organizations adhere to guidelines that protect patient safety. United Ad Label excels at understanding the compliance landscape and providing labeling solutions that both meet those guidelines and elevate patient safety. Explore our broad range of products that address the needs of compounding pharmacies. Contact us to learn more.