In general

(a)

Non-Transplant Tissue Bank license

(1)

Prohibition

No person may introduce or deliver for introduction into interstate commerce any human tissue specimen for medical research or education unless— (A)a tissue bank license is in effect for the entity introducing the human tissue specimen into interstate commerce; (B)each package of the human tissue specimen is— (i)labeled with the proper name of the human tissue specimen contained in the package; (ii)the name, address, and applicable license number of the source tissue bank of the human tissue specimen; (iii)unique donor identifier, tissue type, cause of death, serological test results and any known infectious disease agents; (iv)a statement about the mandatory use of personal protective equipment and universal precautions when handling human tissue; and (v)labeled not for transplantation; and (C)each package of the human tissue specimen is wrapped and packaged in such a manner that— (i)mitigates potential contamination and cross contamination; (ii)mitigates potential safety hazards; (iii)sealed to prevent leakage; and (iv)ensures the integrity of the tissue. (2)

Procedures established

(A)

In general

The Secretary of Health and Human Services shall establish, by rule, requirements for the approval, suspension, and revocation of non-transplant tissue bank licenses. (B)

Approval

The Secretary shall approve a non-transplant tissue bank license application— (i)on the basis of a demonstration that— (I)the human tissue specimen that is the subject of the application is legally donated, properly screened for communicable disease agents, properly labeled, transported, stored and used according to the donor’s donation authorization; and (II)the facility in which the human tissue specimen is donated, recovered, processed, packed, or held meets standards designed to assure that the human tissue specimen does not pose a communicable disease risk to the general public and/or unknown communicable disease risk to; and (ii)if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c) of this section. (3)

Requirements for exemption

The Secretary shall prescribe requirements under which a human tissue specimen shall be exempt from the requirements of paragraph (1). (b)

Falsely labeling or marking package or container; altering label or mark

No person shall falsely label or mark any package or container of any human tissue specimen or alter any label or mark on the package or container of the biological product so as to falsify the label or mark. (c)

Inspection of establishment for propagation and preparation

(1)

In general

Any officer, agent, or employee of the Department of Health and Human Services, authorized by the Secretary for the purpose, may during all reasonable hours enter and inspect any establishment for the propagation or recovery and preparation of any human tissue specimen. (2)

Inspection by nationally recognized accrediting bodies

Any authorized agent of a nationally recognized accrediting body authorized by the Secretary for the purpose, may during all reasonable hours enter and inspect any establishment for the propagation or recovery and preparation of any human tissue specimen. (3)

Rule of construction

Nothing in this subsection or Act limits any existing authority of the Attorney General, any State Attorney General or local law enforcement to enter and inspect any establishment for the propagation or recovery and preparation of any human tissue. (d)

Recall of specimen presenting imminent hazard; violations

(1)

Recall

Upon a determination that a human tissue specimen or collection of specimens licensed under this section presents an imminent or substantial hazard to the public health, the Secretary shall issue an order immediately ordering the recall of such batch, lot, or other quantity of such product. An order under this paragraph shall be issued in accordance with section 554 of title 5. (2)

Violations

Any violation of paragraph (1) shall subject the violator to a civil penalty of up to $10,000 per day of violation. The amount of a civil penalty under this paragraph shall, effective December 1 of each year beginning 1 year after the effective date of this paragraph, be increased by the percent change in the Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base quarter of the preceding year, adjusted to the nearest 1/10 of 1 percent. For purposes of this paragraph, the term base quarter, as used with respect to a year, means the calendar quarter ending on September 30 of such year and the price index for a base quarter is the arithmetical mean of such index for the 3 months comprising such quarter. (e)

Penalties for offenses

Whoever violates any of the provisions of this section shall be imprisoned not more than 1 year, or fined not more than $500, or both. Section 3571 of title 18, United States Code shall not apply to an offense under this subsection. (f)

Construction with other laws

Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding under any existing provisions under current Federal law. (g)

Human tissue specimen defined

In this section, the term non-transplant tissue specimen means legally donated anatomical segments, cells, collection of cells, bodily fluids, or the complete body that are recovered for medical research and education. The term does not include anything that would qualify as a biological product under the Public Health Service Act.