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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.
How do you determine whether or not these regulations apply to you? Below are some common examples to guide you through this complex topic.
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.
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.
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]:
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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,.
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.
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.
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:
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
[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)
[vi] C-TPAT: Customs-Trade Partnership Against Terrorism https://www.cbp.gov/border-security/ports-entry/cargo-security/ctpat
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