What it is
HCT/P stands for human cells, tissues, and cellular and tissue-based products. The FDA uses this term for products made from human tissue, such as some amniotic membrane products. A '361 HCT/P' refers to a section of the Public Health Service Act. Products that meet certain criteria are regulated under that section, mainly with rules aimed at preventing the spread of disease.
To fit the 361 category, a product generally has to meet several conditions. These include being minimally processed and intended for a similar use in the recipient as in the donor. Whether a particular product meets those conditions is a regulatory question. A product's label or marketing does not settle it.
A 361 HCT/P is not an FDA-approved drug. Products that don't meet the 361 criteria are generally regulated as drugs, biologics, or devices and follow a different, more demanding pathway. Most amniotic-derived eye drops and serums are not FDA-approved as drugs. Autologous serum tears are compounded by a pharmacy from the patient's own blood. They are also not an FDA-approved drug. Some amniotic membrane devices are regulated as human tissue products, which is a different pathway again.
How it’s traditionally been approached
Eye care has long used donated human tissue in some settings. Amniotic membrane is one example, and eye doctors have used it in various ways over the years. How a given product is regulated depends on how it is made, processed, and intended to be used.
Autologous serum tears have traditionally been prepared through compounding pharmacies for patients whose eye doctors consider them appropriate. They are made from the patient's own blood. They are not an FDA-approved drug, and compounding practices are overseen differently than drug approval.
In recent years, amniotic-derived drops and serums have drawn more attention, and so has the question of how they are regulated. Some companies describe products as 361 HCT/Ps. Others pursue different regulatory pathways. This is why regulatory status is worth asking about directly rather than assuming.
How the right eye doctor may help
A licensed eye doctor can examine your eyes, review your history, and talk through whether any product category is appropriate for you. Some people come in for dry eye treatment questions and leave with a better sense of the options. Others learn that a different approach fits better. A visit may include an eye exam, questions about symptoms and health, and time to discuss your concerns. No outcome is promised.
If a provider mentions an amniotic or serum product, you can ask about it directly. Useful questions include: What exactly is this product? Where does it come from, and how is it processed? Is it an FDA-approved drug, a 361 HCT/P, a device, or something else? Who regulates it, and why does that classification apply?
It's also reasonable to ask about total cost, what is and isn't covered by insurance, and what the alternatives are. A good provider will welcome these questions. Only a licensed clinician can decide what is appropriate for you after an evaluation, so use this page as a starting point for that conversation.
The whole-person view
Living with uncomfortable eyes can wear on the whole person. Body, mind, and stress affect each other, and ongoing discomfort can influence sleep, focus, and mood. Looking at the whole picture can be a helpful way to think about your care alongside what your eye doctor recommends.
Some people find body-based support, such as the approaches offered through Somatic Experiences, helpful for stress. Others value talk therapy through Therapists.plus. These are optional supports. They don't replace an eye doctor's evaluation, and no approach is better than another.
Keep in mind
- This page is educational only and is not medical advice, a diagnosis, or a recommendation of any product.
- A 361 HCT/P designation is not FDA drug approval, and it does not mean a product has been shown to treat any condition.
- Licensed professionals should guide your care, including decisions about any product made from human tissue or blood.
- For an emergency, such as sudden vision loss or severe eye pain, call 911. In a crisis, call or text the 988 Lifeline.
Not sure where to start? Answer a few gentle questions and choose who you’d like to hear from.
Frequently asked questions
What is a 361 HCT/P product?
A 361 HCT/P is a human cell or tissue product regulated by the FDA under section 361 of the Public Health Service Act. These products must meet specific criteria, such as minimal processing and homologous use. It is not the same as an FDA-approved drug.
Are 361 HCT/P products FDA approved?
No. A 361 HCT/P is regulated under a different pathway and doesn't go through FDA drug approval. The FDA's rules for these products focus mainly on preventing disease transmission. Ask your eye doctor how a specific product is classified.
Are amniotic eye drops FDA approved?
Most amniotic-derived eye drops and serums are not FDA-approved as drugs. Some companies describe them as 361 HCT/Ps, but whether a product truly qualifies is a regulatory question. Ask a licensed eye doctor about a product's source, processing, and regulatory status.
Are autologous serum tears FDA approved?
No. Autologous serum tears are compounded by a pharmacy from the patient's own blood and are not an FDA-approved drug. A licensed eye doctor decides whether they are appropriate after an evaluation.
Is a 361 HCT/P the same as a stem-cell treatment?
No. Most amniotic tissue products contain no living stem cells after processing, and they shouldn't be called stem-cell treatments. Ask your provider exactly what a product contains and how it is processed.
What should I ask my eye doctor about a dry eye treatment product's FDA status?
Ask whether the product is an FDA-approved drug, a 361 HCT/P, a device, or a compounded preparation. Also ask about its source, processing, and total cost. A licensed eye doctor can explain whether it fits your situation after an evaluation.
Educational resource. Placenta-Derived Eye Serum shares general information and connects people with independent eye doctors. It is not medical advice, diagnosis or treatment. Talk with a licensed professional about your health.