Regulations for Blood Bankers I: Laws vs. Regulations and FDA 101

When I first dipped my toes into cellular therapy regulations, it felt like drowning in alphabet soup: PHS Act, FD&C Act, Title 21 CFR, CBER, CDER. Each acronym seemed to point in a different direction, and none of them came with a map.

But beneath the jargon, there’s a simple framework: laws set the authority, regulations explain the rules, and FDA enforces both.

Laws vs. Regulations: Who Does What?

• Laws are written by Congress. They set the what: broad mandates about safety, efficacy, and public health. In our world, two laws matter most:

  • The Public Health Service (PHS) Act — governs biologics, including blood, tissues, and cellular therapies. It uses the famous triad: products must be safe, pure, and potent.

  • The Federal Food, Drug, and Cosmetic (FD&C) Act — governs drugs and devices, with a slightly different test: products must be safe and effective.

• Regulations are written by FDA under the authority of those laws. They set the how. Regulations are published in the Code of Federal Regulations (CFR), and for our field, it’s Title 21 (Food and Drugs).

  
  

👉 Think of it this way:

• Congress says: “Biologics must be safe, pure, and potent.”

• FDA says: “Okay—here’s the rulebook for how you prove it: sterility testing, donor screening, validated potency assays, manufacturing standards.”

  
  

The FDA’s Structure: Who Regulates What?

FDA sits within the Department of Health and Human Services (HHS). Within FDA, there are centers—each with its own slice of responsibility.

• CBER (Center for Biologics Evaluation and Research) → blood, cellular and gene therapies, tissues, vaccines, and related diagnostics.

• CDER (Center for Drug Evaluation and Research) → drugs in the traditional sense: small molecules, monoclonal antibodies, most therapeutic proteins.

  
  

That’s why CAR-T cell therapy sits in CBER, while rituximab (a monoclonal antibody) sits in CDER—even though both are used in hematology.

This split confuses everyone at first, but it makes sense if you remember: CDER handles things that look like “chemicals in vials,” while CBER handles things that look like “cells, tissues, or blood.”

Blood: The Perfect Example of Overlap

Nothing illustrates the intersection of laws and regulations better than blood.

• Under the FD&C Act, blood is a drug.

• Under the PHS Act, blood is a biologic.

  
  

That dual status means blood establishments must comply with a lattice of regulations:

• 21 CFR 210/211 — current good manufacturing practice (drugs).

• 21 CFR 600+ — general biologics requirements.

• 21 CFR 606 — blood establishment rules (donor eligibility, testing, quality systems).

• 21 CFR 640 — component-specific standards (RBCs, platelets, plasma, cryoprecipitate).

  
  

If you’ve ever wondered why blood banking feels so heavily regulated, this is the reason: it’s both.

Why Start Here?

Because if you can understand how laws and regulations apply to blood—the most familiar cellular product—you’ll be better equipped to navigate the more complex world of stem cells, tissue grafts, and CAR-T therapies.

Blood shows us three truths right away:

1. Laws (PHS Act, FD&C Act) set the foundation.

2. Regulations (21 CFR) provide the details.

3. FDA (CBER/CDER) enforces both, often in overlapping ways.

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Once you see that pattern, the acronyms and numbers stop being noise. They start to form a map.

📌 Coming up in Part Two: We’ll dig into the fork in the road between PHS 351 vs. 361, how FDA decides if a product is a “biologic” versus a “tissue,” and what it actually takes for a 351 product to go from bench to bedside