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Is your product FDA approved?
FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself. The Agency does this pre-market review for new human drugs and biologics (such as vaccines, blood products, biotechnology products and gene therapy), complex medical devices, food and color additives, infant formulas, and animal drugs. Click here for more information on FDA Approval of Products
What allows your product to be stored at room temperature? Are there preservatives in it?
Co-op Donor Milk is 100% human milk with NO preservatives. Treating the incoming raw milk in specially-designed equipment ensures the safety and wholesomeness of the product while not affecting the quality of the milk. This is the same process utilized for preemie infant formulas. Medolac processed donor milk is the ONLY donor milk that is commercially-sterile which is why it can be at room temperature. Commercial sterility renders the milk free of:
How does your thermal process affect the constituents of human milk?
Visit our Data and Publications Center for more information on Analysis of the Influence of Processing on Human Milk's Macronutrient Concentration, and Amino Acid Retention.
Why don't you use Holder Pasteurization?
Vegetative cells, spores and toxins can and do survive Holder pasteurization. Medical professionals may be unaware of the differences between commercial sterility and Holder pasteurization and the methods used by process authorities to professionally process a wide range of food, now including human donor milk. This article is intended to guide the medical professional through the technical and legal aspects of thermal processing methods as well the scientific literature that supports the need for commercially sterile milk for fragile neonates. Click here to read the rest of the article
Are you regulated or certified in any way?
On a Federal level human milk is regulated by the FDA as a food. In a number of states, human milk is regulated by Tissue Banking Authorities as a human tissue. Medolac is compliant with the above regulations. We not only meet but exceed recommended standards for safety and quality. Our dedication to the highest level of safety and quality is underpinned by the fact that we have developed the first only commercially-sterile human milk.
Do you have restrictions on donor milk usage?
No. Since the development of new and innovative donor milk programs, Medolac has ample supply of product and supports the decisions of healthcare providers to use our products as they see fit.
Is your product available for home use?
Yes. Families in need of donor milk can order online. The cost of Co-op Donor Milk for home use is subsidized to improve access to infants in need of donor milk.
Do you have any published studies using your products?
Yes! Visit our Data and Publications Center to access a published paper on Growth and Tolerance.
How much do your products cost?
The Hospital list price of Co-op Donor Milk is $5.95 per ounce. This price can be discounted with annual volume commitment.
How long after opening can Medolac products be used?
Co-op Donor Milk can be used for up to twelve hours at room temperature after opening. Click here for information on storage under refrigerated conditions.
FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself. The Agency does this pre-market review for new human drugs and biologics (such as vaccines, blood products, biotechnology products and gene therapy), complex medical devices, food and color additives, infant formulas, and animal drugs. Click here for more information on FDA Approval of Products
What allows your product to be stored at room temperature? Are there preservatives in it?
Co-op Donor Milk is 100% human milk with NO preservatives. Treating the incoming raw milk in specially-designed equipment ensures the safety and wholesomeness of the product while not affecting the quality of the milk. This is the same process utilized for preemie infant formulas. Medolac processed donor milk is the ONLY donor milk that is commercially-sterile which is why it can be at room temperature. Commercial sterility renders the milk free of:
- Microorganisms capable of reproducing in the food under normal non-refrigerated conditions of storage and distribution; and
- Viable microorganisms (including spores) of public health significance; or
- By the control of water activity and the application of heat, which renders the food free of microorganisms capable of reproducing in the food under normal non-refrigerated conditions of storage and distribution.
How does your thermal process affect the constituents of human milk?
Visit our Data and Publications Center for more information on Analysis of the Influence of Processing on Human Milk's Macronutrient Concentration, and Amino Acid Retention.
Why don't you use Holder Pasteurization?
Vegetative cells, spores and toxins can and do survive Holder pasteurization. Medical professionals may be unaware of the differences between commercial sterility and Holder pasteurization and the methods used by process authorities to professionally process a wide range of food, now including human donor milk. This article is intended to guide the medical professional through the technical and legal aspects of thermal processing methods as well the scientific literature that supports the need for commercially sterile milk for fragile neonates. Click here to read the rest of the article
Are you regulated or certified in any way?
On a Federal level human milk is regulated by the FDA as a food. In a number of states, human milk is regulated by Tissue Banking Authorities as a human tissue. Medolac is compliant with the above regulations. We not only meet but exceed recommended standards for safety and quality. Our dedication to the highest level of safety and quality is underpinned by the fact that we have developed the first only commercially-sterile human milk.
Do you have restrictions on donor milk usage?
No. Since the development of new and innovative donor milk programs, Medolac has ample supply of product and supports the decisions of healthcare providers to use our products as they see fit.
Is your product available for home use?
Yes. Families in need of donor milk can order online. The cost of Co-op Donor Milk for home use is subsidized to improve access to infants in need of donor milk.
Do you have any published studies using your products?
Yes! Visit our Data and Publications Center to access a published paper on Growth and Tolerance.
How much do your products cost?
The Hospital list price of Co-op Donor Milk is $5.95 per ounce. This price can be discounted with annual volume commitment.
How long after opening can Medolac products be used?
Co-op Donor Milk can be used for up to twelve hours at room temperature after opening. Click here for information on storage under refrigerated conditions.
