Medical practices rely on pharmaceutical repackaging to reduce larger quantities of prescription drugs to smaller, patient-specific units. As a result, your medical practice can expect a higher degree of efficiency while retaining high standards of patient care.

Finding the right repackaging company is crucial. The best providers offer affordable repackaging solutions while also storing, packing, and labeling medications according to the most rigorous regulatory standards. As a result, medical practices can have greater confidence in the pharmaceuticals that they dispense and ensure adherence to federal and industry guidelines.

Understanding Pharmaceutical Repackaging

Pharmaceutical repackaging refers to the process of taking drug products from one container to another without altering the actual medication. Pharmaceutical repackaging companies commonly purchase wholesale quantities of prescription drugs before repackaging these medications for healthcare providers. Common examples of repackaging medication can include unit-dose packaging and blister packs designed for individual patients.

Medical practices receive such benefits as:

  • Individualized doses without the cost of purchasing mass quantities of a drug
  • Greater accuracy in the type and dose of medication being dispensed
  • Reduced prep time, translating into higher pharmacy output
  • Improved inventory management
  • Reduced availability of controlled substances to prevent abuse

The entire process must be completed with a high degree of precision and care. The U.S. Food and Drug Administration (FDA) oversees the repackaging process to ensure sterile procedures and proper labeling. The FDA also makes sure the drugs will not be exposed to improper lighting or temperatures.

Key Considerations When Choosing a Repackaging Company

It’s important to source your repackaged drug products from a reliable repackaging distributor. Here are some things to look for in a repackaging company.

The Range of Repackaging Services

Common repackaging services include:

  • Unit-dose packaging (packaging pharmaceutical products into individualized doses)
  • Commercial repackaging (updating packaging to reflect new regulatory standards or labels)
  • Bulk repackaging (repackaging large quantities into smaller packages for resale)

When repackaging medications, some operations also assist in the pharmaceutical supply chain to provide timely delivery and inventory management. Prepackaged medication dispensing brings fresh inventory to pharmacies and healthcare centers.

Quality and Safety Standards

Pharmaceutical repackaging companies must adhere to the highest standards of safety and quality control. Proper packaging involves the use of container closure systems and monitoring storage conditions to preserve the effectiveness of every medication.

Industry Reputation

Medical practices, pharmacies, and outsourcing facilities should carefully consider the industry reputation of a repackaging provider. A company with a solid track record of excellence will give you greater confidence in its ability to provide quality services in the future.

Technological Capabilities

Thanks to technology, repackaging medication has become both more efficient and more accurate while ensuring adherence to complex regulatory standards. Automated systems have made the repackaging process lightning-fast and minimized the kinds of errors that creep in from manual data entry. Pharmaceutical repackaging companies also rely on supply chain technology to monitor their inventories and optimize routes for fast, efficient delivery.

The packages themselves are a product of innovation. Prepackaged medication and vials include barcodes and other identifying labels to assist in record-keeping, inventorying, and monitoring of the relative expiration dates of stored medications. This also aids in regulatory compliance, as it demonstrates that medications are being stored under appropriate light/temperature conditions.

Regulatory Compliance:

The FDA provides oversight to all medical care facilities and state-licensed pharmacies. Regulations include:

  • Accurate labels
  • Tamper-evident packaging
  • Maintaining a sterile environment for storage and handling

More significantly, pharmaceutical repackaging companies must adhere to strict labeling guidelines. Each label needs to prominently display information such as the:

  • Drug name
  • Dosage
  • Usage information
  • Beyond-use date

The FDA sets Current Good Manufacturing Practice (CGMP) guidelines for the safe handling, storage, and repackaging of prescription drugs. Repackaging companies abide by these guidelines in their operations and in their commitment to accurate labeling and storage.

If a repackaging company does more than just repackage medication — and actually alters the formulations of these drugs — the FDA classifies it as a manufacturer. This means the company is subject to an additional set of regulations set by the FDA and Drug Enforcement Agency (DEA). One such regulation is the Controlled Substances Act (CSA), which classifies medications partly on the basis of dependence potential.

Quality Control Measures

Quality control measures provide the highest level of patient safety. Quality control measures can be broken down into three broad categories.

Environmental Control

The repackaging of certain human drug products demands specific environmental conditions. Repackaging facilities must maintain appropriate temperature, lighting, and relative humidity for every medication they handle. These conditions must also be maintained in the repackaging, storage, and transportation of drugs.

Labeling and Documentation

Repackaging companies are also required to adhere to the FDA’s strict standards for drug labeling. These labels play a role in monitoring things like expiration dates, as well as in creating visibility for the repackaging and distribution of certain controlled substances.


A physical inspection provides a final layer of quality assurance. Packages can be inspected to ensure proper labeling, and even the environment itself can be inspected to confirm that proper conditions are being maintained.

Customization for Practice Needs

Every healthcare practice is different. Pharmaceutical repackaging providers can offer tailored solutions to satisfy specific pharmacy services, such as:

  • Custom batching services
  • Deblistering and debottling for individualized dosages
  • Custom barcoding and serialization for inventory control
  • Software solutions to improve the ordering process
  • Specialized labeling to help patients take their meds properly

If your medical practice has a particular need, a pharmaceutical repackaging company can help you devise an innovative, affordable solution.

Cost Considerations

Most repackaging services offer customizable payment options. For example, you might consider bundled options that allow you to receive multiple types of medications and services at a discount. 

Customer Support and Training

Customer support and training are essential for maintaining the quality of repackaged drugs and minimizing any medication errors that arise from misreading labels. Repackaging companies can offer assistance in this department by providing training in the proper storage, handling, and administration of each drug that they sell.

Some of the best training is specific to the drugs that the company repackages for the medical provider. Helping providers understand proper storage and handling can preserve the efficacy of the drug, which also impacts the health and care of each patient.

The best repackaging companies offer direct training as well as ongoing support via email, phone, and online chat. When a patient’s health matters, you want a company that’s going to offer the best and most accessible support options.

Future Trends in Pharmaceutical Repackaging

AI-powered systems will continue to transform the healthcare landscape, including pharmaceutical repackaging. With smarter, adaptive systems, repackaging companies can achieve greater speed while retaining even higher standards of quality control.

It’s also likely that healthcare systems will see evolving regulations regarding controlled substances. Regulatory concerns will present unique challenges for the safe storage and dispensing of opioid medications, which may only highlight the need to partner with a repackaging company adept at navigating these regulatory concerns.

Find a Provider That Fits Your Practice

When choosing a pharmaceutical repackaging company, you want a provider who understands your unique needs while always adhering to FDA regulations and industry best practices. You also want a company that will support you and your staff in implementing solutions that meet your high standards of patient safety and care.

Proficient Rx can provide in-office dispensing for a customizable solution for you and your valued patients.

Contact us today to explore how we can transform your medical practice.