All You Need to Know about Pharmaceutical Repackagers

Learn the basics about pharmaceutical repackagers
 

Today, more than ever before, it is easier for consumers to reach for their computer, Smartphone or tablet before making purchasing decisions.  Consumers can (and do) conduct research online to learn about such issues as what is driving up the cost of health care and prescription drugs.    Now patients simply peruse the Internet to select healthcare providers, look up information about side effects of brand name and generic drugs and research how pharmaceutical companies across the supply chain deal with quality assurance concerns.

In the next few months, American consumers will again make vital decisions about health care.  Many will spend hours online researching primary care doctors and healthcare providers, examining health care insurance policies.  From employees to business owners, the rising cost of heath care and prescription drugs has most Americans concerned and interested in learning how costs can be kept under control. 

If you are like most consumers, you may not be aware of the vital role that drug repackagers play in the pharmaceutical supply chain. 

As patients, consumers are prescribed medications which are filled by pharmacies and the drugs are dispensed without a thought to how it all happens.

Whether a patient is dispensed medication from a doctor, hospital, pharmacy, rehab or nursing care facility or other institution, the medication may have originally been packaged in large quantities, rather than individual doses.  Increased concerns regarding the quality and cost of healthcare as well as concerns about patient safety have ramped up the need for more unit-dose medications.

Here is a brief look at one type of pharmaceutical supply chain industry operation that helps reduce cost, improve patient safety and the accuracy of drug dose dispensation.

What is a Pharmaceutical Repackager?

Many medications are packaged in large quantities by drug manufacturers.  In general, a pharmaceutical repackager purchases medications wholesale, often generic drugs, then repackages them into smaller quantities for sale to doctors.  Doctors then sell the repackaged drug products in their offices.  Repackaged medications are also sold to pharmaceutical distributors, hospitals or other pharmacies.

Pharma repackagers fill an important role in the healthcare industry and help meet a wider range of needs, repackaging drug products from:

  • One-to-multiple
  • Multiple-to-one
  • Multiple-to-multiple
  • Unit-dose
  • Current packaging Into convenience kits
  • Solid & liquid oral dosage form into unit-dose containers
Shared service repackaging operations serve the needs of either one or multiple hospital facilities as well as related institutions.  In this instance, each entity lacks separate or does not have pharmacy services.  Each entity is responsible for the restriction of the distribution of drug products received from the shared service establishment.

According to the FDA, pharmaceutical repackaging is “the act of removing a preparation from its original primary container and placing it into another primary container, usually of smaller size.”  Pharmacies commonly repackage preparations into unit-dose configurations for patients.  In this blog, we are specifically including information on commercial pharmaceutical repackaging organizations.

Commercial repackaging companies repackage drug product preparations for distribution.  This can mean that the drug products are for resale to hospitals, distributors or other pharmacies. Repackaging firms that are FDA-registered regularly receive drugs from hospitals and clinics which are then repackaged into unit-dose packages.  This facilitates accurate dispensation of doses to patients and is more convenient for healthcare providers.  Operating with a higher level of scrutiny, control, security and quality control, regulated repackagers accomplish the same tasks as other facilities but incur more cost.  Because of this, regulated repackagers charge accordingly to maintain a level of profitability.  Repackagers are regulated in a very similar manner to how the FDA regulates the packaging operations of the original prescription drug manufacturers.

Why Repackage Prescription Drugs?

Here are some of the primary reasons for repackaging prescription drug products:

  • Makes it easier to serve the needs of individual groups of patients who may require smaller doses of drugs than are available commercially
  • Decreases medical and dispensation errors
  • Cuts down on prep time, increasing efficiency
  • Helps increase pharmacy output
  • Decreases drug product waste
  • Facilitates effective inventory management
  • Reduces the availability of drug products to prevent abuse
  • Facilitates use of a specific sized container for use with a particular drug dispensation device
  • Makes it faster and easier for practitioners

Types of Repackagers

Here are some of the different types of pharmaceutical repackagers (sometimes referred to as drug repackers):

  • Companies which purchase medications from a wholesale distributor or manufacturer then specialize in repackaging the drug products into a new package type. This may be into a smaller or larger quantity package or type of package such as from a bottle into blister cards or unit dose packs that can be used in an automated picking machine.
  • Contract packager
  • Contract repackagers are third party service providers that do not own the drug products but rather only repackage medications as a service to the inventory owner.
  • Companies that relabel drug products
  • Pharmacies

Typical Clients of Drug Repackagers

  • Healthcare institutions including private clinics, nursing care facilities
  • Healthcare providers
  • Hospital and privately-owned pharmacies

Good Repackaging Practices

The FDA conducts a thurough drug application review and approval process during which the container closure system and drug packaging are evaluated as well as the conditions under which the drug will be packaged are carefully considered.  This is done as these factors can impact the quality of the drug product.  Quality assurance is always a primary concern for repackagers.

The FDA evaluation is conducted to help ensure that the packaging and closure system are appropriate for maintaining the stability of the drug product until its expiration date, presuming that the drug is stored according to the conditions specified in the application and there is no breach in the container or closure.  Some drug products are required to be sterile.  The FDA considers the packaging and closure system carefully and evaluates whether the drug product will remain sterile, presuming appropriate storage conditions and lack of a breach to the closure or packaging.
It is possible that drug characteristics may change when repackaged.  This may happen in a manner that is unforeseen during the FDA approval process, impacting the safety and efficacy of the prescription drug product.  It is also important to note that serious adverse events may occur when drug products are improperly packaged.  It is notable that when products are repackaged using practices which conflict with approved product labeling, the result may be drug product degradation, impurities in the drug project or lack of efficacy due to deterioration of the active ingredient.  This may lead to adverse events for patients.

Pharmaceutical Repackagers and FDA Compliance Issues

Pharmaceutical repackagers should never alter the drug product itself in any way.  The repackager may not change the dosage form, dilute the product, mix the product with other solutions, substances, chemicals, etc.

If a repackaging company does alter the drug product in any of these ways, the FDA would consider the entity to be a pharmaceutical manufacturer and all the regulations regarding that entity would be applicable.

  • Must register with FDA
  • Expected to meet requirements of packaging practice under 21 CFR 210 through 226
  • Must comply with provisions of the FD&C Act related to drug production such as:
  • Pre-market approval, misbranding, adulteration, as well as drug supply chain security provisions of FD&C Act including:
    • Section 505 regarding new drug applications
    • Section 502 (f) (1) regarding labeling with adequate directions for use
    • Section 501 (a) (2) (B) regarding Current Good Manufacturing Practice (CGMP)
    • Section 582 regarding drug supply chain security
  • CGMP 21 code of FDA regulations CFR 210 and 211

Conclusion

The pharmaceutical supply chain is complicated.  Since approximately 2006, drug repackagers have made an impact on the pharmaceutical industry, helping to reduce costs and enhance patient safety.  As many medications are not packaged by the original manufacturer in unit doses or are produced and packaged in bulk, a need for repackaging medications arose.  Repackaging prescription drug products helps to reduce medication errors, increasing the safety of patients and the quality of drug products.  The overall effect of pharma repackaging is positive, lowering costs and resulting in greater efficiencies in the pharmaceutical supply chain.

About the Author:

Laura Olson

Director of Sales and Marketing, Datex

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