Medical & Health Care Product Regulations & Warehouse Requirements

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Many medical and health care products are regulated by the Food and Drug Administration (FDA) and other agencies. Both business owners and warehouse companies need to understand how to handle, store, pack, ship, and track medical and health care products using procedures that comply with government standards.

Medical and Healthcare Warehousing

How do you determine whether or not these regulations apply to you? Below are some common examples to guide you through this complex topic.

Non-regulated products

Cosmetics, vitamins and supplements, other beauty/health-related products may benefit from special handling, but they may not require that a warehouse to maintain the same certifications that are needed for drugs and sterile medical supplies. Specific items like nail polish, perfumes, and skin cleansers or moisturizers are subject to FDA regulations, as are some additives for color that are sometimes ingredients in makeup. Because of these detailed distinctions, it’s best to check the FDA directly about their current requirements for health care goods like cosmetics and beauty products. 

FDA-regulated products

Institutions such as health care organizations, pharmaceutical companies, scientific groups, and research facilities are likely regulated by the FDA, because they produce and sell items that can are obviously categorized as drugs, medical/surgical devices, or diagnostic tools. Some of these products need to be kept at a specific temperature, labeled discreetly for security reasons, or kept perfectly sterile (free from bacteria). Others need to be carefully tracked throughout the fulfillment process.

Medical devices

The FDA defines a medical device as any item that is designed and intended for human use in the diagnosis or treatment of a disease, or an apparatus that can modify the anatomy or a physiological process.  The range of products that fit these criteria is quite large; a medical device can be anything from an adhesive bandage to a neuromuscular implant.

Medical devices are grouped into one of three distinct classes, depending on the level of regulation needed to mitigate potential risks[i]:

  • Class I medical devices are subject to the fewest controls, because they don’t pose a great threat to others if mishandled. The FDA’s “general controls” on these devices include provisions relating to misbranding, device registration, and good manufacturing processes. Examples of Class I medical devices include tongue depressors, sunglasses, gloves, or an IV stand.
  • Class II devices must meet the requirements of Class I regulations (“general controls”) plus comply with “special controls” such as labeling standards, tracking requirements, design guidelines, mandatory performance standards, and post-market monitoring rules. Items such as surgical masks, powered wheelchairs, or syringes fall into this category.
  • Class III items are extremely specialized and present a high risk of illness/injury, therefore their controls are the most stringent. These are life-sustaining products like implants (heart valves, pacemakers, etc.) that require scientific review and approval in addition to the requirements for Classes I and II.

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Although the FDA doesn’t require or recognize the ISO (International Organization for Standardization), almost all manufacturers of medical devices want their critical vendors to be ISO 13485 certified showing they have significant control and risk mitigation processes in place that document and show evidence of consistency in every key function they perform including detailed tracking of lot and serial number.  “This certification level gives stand-out credibility to warehousing companies seeking customers in the rapidly growing medical device industry in both forward and reverse logistics” says Steve Storr,.

  • ISO 9001[ii] is a quality management system that helps certified businesses ensure that their customers consistently receive high quality products and services.
  • ISO 13485[iii] sets forth quality controls and regulations specific to medical devices and their associated services. These standards apply to every aspect of the life cycle of a product and to any organization involved in the development, distribution, or implementation of that medical device.

Pharmaceutical products

As you might expect, there are several governing entities for the pharmaceutical industry. The main goal of these agencies is to ensure the overall safety of consumers, but their efforts also reduce of fraud and drug abuse, enhance health care provider operations, and aim to improve the quality of health care overall. The processes that manufacturers must develop and implement to comply with these regulatory groups are frequently complex and detailed.

  • Current Good Manufacturing Practices (CGMP) is the main regulatory standard for ensuring the quality of human pharmaceuticals as enforced by the FDA. The CGMPs provide systems for manufacturers to use to ensure that their products are as safe and pure as possible, and that their operations are fully equipped to maintain a high level of quality control. These standards apply mainly to the drug companies, but the storage, handling, and shipment of their products may fall under these regulations.[iv]
  • The Drug Enforcement Administration (DEA) is a government agency that combats the smuggling and use of illegal drugs in the United States. It would be the responsibility of the fulfillment company to ensure the highest level of security for drugs they handle for their pharmaceutical companies, and to comply in all other ways with the regulations put forth by the DEA.
  • The Drug Supply Chain Security Act (DSCSA) provides a system of tracking certain drugs through the supply chain to help the FDA ensure that consumers are not exposed to harmful products. As it relates to distributors: “The DSCSA requires wholesale distributors and third-party logistics providers to report licensure and other information annually to FDA. Additionally, to further enhance the security of the drug supply chain, manufacturers, repackagers, wholesale distributors, and dispensers are required to notify FDA and other trading partners within 24 hours after determining a product is illegitimate. See frequently asked questions for more information about filling out Form FDA 3911 for a drug notification.”[v]

Other potential regulations

This list is not exhaustive; there might be other requirements that apply to warehousing operations depending on the products they are handling. For instance, international shipments might be governed by the Customs-Trade Partnership Against Terrorism (C-TPAT)[vi] if the business owner has elected to participate in this voluntary partnership. This agreement between the government and the company adds a level of security certification to the business activities of this company and assists with border control processes by streamlining inspections.

General warehouse preparedness

Obviously, with so many details and laws to keep track of, you must be extremely careful when choosing a fulfillment partner for your medical/healthcare products.  A select few companies, such as Mendtronix, provide specialized services in the health and medical industries. While the regulations described above will dictate specific requirements for warehousing companies as needed, the basic characteristics of a fulfillment company that can handle all kinds of medical and health care products are as follows:

  • At a minimum, a warehouse that plans to handle medical or health care products should be clean and well-maintained overall.
  • The facility should have robust security systems in place; certain drugs and controlled substances are highly sought after and need to be protected from theft.
  • Fulfillment centers must be climate-controlled and have appropriate redundancy/backup power supply in the event of power loss. An increase in temperature can permanently damage fragile and perishable health care items and even jeopardize heat-sensitive medical devices.
  • Most pharmaceuticals and some types of equipment and require special attention to inventory called expiration date tracking. A warehousing company should be familiar with three common methods of this tracking:
    • FIFO – “first in, first out” means that goods are sold in the order they were received at the warehouse
    • LIFO – “last in, first out” means that the items that were most recently added to the inventory are the next in line to go out
    • FEFO – “first expired, first out” means that products that will be expiring first are prioritized for sale
  • A fulfillment center that is ready to process medical products and health care items should also have the capability to provide customized and specific packaging solutions, such as:
    • Inconspicuous labeling for certain drugs or devices, to prevent theft
    • Cold packs or insulation for highly temperature-sensitive products
    • Special handling to ensure the integrity of sterile items

The FDA provides helpful guides to help you categorize products on their web site.

[i] FDA Classification Overview (PDF) https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466473.pdf

[ii] ISO 9001:2015 https://www.iso.org/iso-9001-quality-management.html

[iii] ISO 13485 https://www.iso.org/standard/59752.html

[iv] Facts About the Current Good Manufacturing Practices (CGMPs) https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm

[v] Drug Supply Chain Security Act (DSCSA)

https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm

[vi] C-TPAT: Customs-Trade Partnership Against Terrorism https://www.cbp.gov/border-security/ports-entry/cargo-security/ctpat

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