U.S. Code » Title 42 » Chapter CHAPTER 6A— PUBLIC HEALTH SERVICE › Subchapter SUBCHAPTER II— GENERAL POWERS AND DUTIES › Part Part F— Licensing of Biological Products and Clinical Laboratories › Subpart subpart 1— biological products

42 U.S.C. § 263

Preparation of biological products by Service

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(a) The Service may prepare for its own use any product described in section 262 of this title and any product necessary to carrying out any of the purposes of section 241 of this title.(b) The Service may prepare any product described in section 262 of this title for the use of other Federal departments or agencies, and public or private agencies and individuals engaged in work in the field of medicine when such product is not available from establishments licensed under such section.(July 1, 1944, ch. 373, title III, § 352, 58 Stat. 703.)Statutory Notes and Related SubsidiariesChange of Name

“Secretary of Health and Human Services” substituted for “Secretary of Health, Education, and Welfare” pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Executive DocumentsTransfer of Functions

Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, set out as a note under section 202 of this title.

Notes of Decisions
Cited in 6 cases, 1983–2013 · leading case: Holcomb v. Carraway, 945 So. 2d 1009 (Ala. 2006).
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Holcomb v. Carraway, 945 So. 2d 1009 (Ala. 2006). · cites it 2× “" 42 U.S.C. § 263 (f)(1)(D). The regulations implementing the MQSA are found at 21 C.”
North Coast Women's Care Med. Grp., Inc. v. Superior Court, 189 P.3d 959 (Cal. 2008). “Brody said, might delay the procedure as North Coast would first have to confirm that its protocols pertaining to donated fresh sperm would satisfy the requirements of North Coast’s state tissue bank license and the federal Clinical Laboratory Improvement Amendments of 1988 ( 42…”
Wade Pediatrics v. Dep't of Health & Human Servs., 567 F.3d 1202 (10th Cir. 2009). “See 42 U.S.C. § 263 (a); 42 C.F.R. Part 493. Among other things, certified labs must participate in periodic quality control proficiency tests.”
United States v. Hodges X-Ray, Inc., 582 F. Supp. 35 (W.D. Ky. 1983). · cites it 2× “Since the Act specifies that a 'manufacturer is liable for penalties for machines manufactured by it, and since the machines were manufactured by the Corporation, it is apparent that the Corporation is still liable for any penalties which might be assessed. Hodges contends that…”
Patel v. Nicholson, 930 F. Supp. 2d 116 (D.D.C. 2013). “2903 (1988), to amend the Public Health Service Act, 42 U.S.C. § 263 (a). The Department of Health and Human Services (“HHS”) published regulations to implement CLIA.”
Boykansky v. Health Care Fin. Admin., 8 F. App'x 516 (6th Cir. 2001). “, a physician office laboratory, petitions for review of a decision by the Department of Health and Human Services Departmental Appeals Board upholding the suspension and revocation of Boykansky’s certificate under the Clinical Laboratory Improvement Amendments of 1988 (CLIA),…”
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