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Abstract

Credit — This lesson is good for 0.2 CE units, with a passing grade of 70%.

Objectives

1. Describe the historical development of federal regulations that affect manufacture of vaccines and antibodies.

2. Describe the procedures used by the Food and Drug Administration (FDA) to enhance manufacturing quality.

3. List examples of actions FDA may take to deal with substandard products or procedures.

Keywords

vaccines antibodies biologics manufacturing regulation laws

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References

Grabenstein

J.D.

Don't say biologics if you mean immunologics. Am J Hosp Pharm. 1988; 45: 1941–2.

Ropp

K.L.

Just what is a biologic, anyway?

FDA Consumer. 1993(Apr): 27–30.

Timm

E.A.

75 years compliance with biological product regulations. Food Drug Cosmetic Law J. 1978; 33: 225–30.

Kondratas

R.A.

The biologics control act of 1902. In: Young

J.H.

, ed., The Early Years of Federal Food and Drug Control. Madison, WI: American Institute of the History of Pharmacy; 1982, 8–27.

Lambert

E.I.

Foods and drugs for animals other than man. In: Brady

R.P.

, Cooper

R.M.

, Silverman

R.S.

, eds., Fundamentals of Law and Regulations, Vol. 1: An In-Depth Look at Foods, Veterinary Medicines, and Cosmetics. Washington, DC: Food and Drug Law Institute; 1997, 285–314.

Adams

D.G.

, Cooper

R.M.

, Kahan

J.S.

, ed. Fundamentals of Law and Regulations, Vol. 2: An In-Depth Look at Therapeutic Products. Washington, DC: Food and Drug Law Institute; 1997.

Piña

K.R.

, Pines

W.L.

, ed. A Practical Guide to Food and Drug Law and Regulation. Washington, DC: Food & Drug Law Institute; 1998.

Parish

H.J.

A History of Immunizations. Edinburgh and London: E&S Livingstone, Ltd.; 1965.

Chase

Magic Shots. New York: William Morrow; 1982.

10.

Hopkins

D.R.

Princes and Peasants: Smallpox in History. Chicago: University of Chicago Press; 1983.

11.

Wilson

G.S.

The Hazards of Immunization. London: Athlone Press; 1967.

12.

Janssen

W.F.

Outline of the history of US drug regulation and labeling. Food Drug Cosmetic Law J. 1981; 36: 420–41.

13.

Fischelis

R.P.

Handling biological products in the drug store. J Am Pharm Assoc. 1916; 5: 841–5.

14.

Williams

R.C.

The United States Public Health Service: 1798–1950. Washington, DC: US Public Health Service; 1951.

15.

Pendergast

W.R.

Biologic drug regulation. In: 75th Anniverary Commemorative Volume of Food and Drug Law. Washington, DC: Food Drug and Law Institute; 1984.

16.

Pittman

A.A.

The regulation of biologic products at NIH, 1902-1972. In: Greenwald

H.R.

, Harden

V.A.

, eds., National Institute of Allergy and Infectious Diseases, Intramural Contributions, 1887-1987. Bethesda, MD: National Institutes of Health; 1987, 61–70.

17.

Anonymous. Establishments licensed for the propagation and sale of viruses, serums, toxins, and analogous products. Public Health Rep. 1911; 26: 137–8.

18.

Stewart

F.E.

The biologicals of the US Pharmacopeia: How vaccines and antitoxins are officially treated: Antitoxins. Pharmaceutical Era. 1917; 50: 9–11; 119–20, 141.

19.

Stewart

F.E.

The biologicals of the US Pharmacopeia: How vaccines and antitoxins are officially treated: Introduction, Smallpox. Pharmaceutical Era. 1916; 49: 429–30; 465–6.

20.

Galambos

, Sewell

J.E.

Networks of Innovation: Vaccine Development at Merck, Sharp & Dohme, and Mulford, 1895-1995. New York: Cambridge University Press; 1995.

21.

Anonymous. Pitfalls in determining the prophylactic or curative value of bacterial vaccines: With special reference to influenza. Public Health Rep. 1919; 34: 1193–4.

22.

Anonymous. Some federal safeguards of the manufacture and distribution of diphtheria toxin-antitoxin mixture. Public Health Rep. 1926; 41: 2650–1.

23.

Anonymous. Public Health Service Act, 1944. Public Health Rep. 1944; 59: 916–7.

24.

Sensabaugh

S.M.

A primer on CBER's regulatory review structure and process. Drug Info J. 1998; 32: 1011–30.

25.

Cooper

R.M.

, ed. Fundamentals of Law and Regulation, Supplement: An In-Depth Look at the 1997 Food and Drug Administration Modernization Act. Washington, DC: Food and Drug Law Institute; 1999.

26.

Nathanson

, Langmuir

A.D.

The Cutter incident: Poliomyelitis following formaldehyde-inactivated poliovirus vaccination in the United States during the spring of 1955. Am J Hyg. 1963; 78: 16–81.

27.

Carter

Breakthrough: The Saga of Jonas Salk. New York: Pocket Books; 1967.

28.

Smith

J.S.

Patenting the Sun: Polio and the Salk Vaccine. New York: William Morrow & Co.; 1990.

29.

Gould

A Summer Plague: Polio and Its Survivors. New Haven: Yale University Press; 1995.

30.

Beatrice

M.G.

Regulation, licensing and inspection of biological products. Pharm Engineering. 1991; 10: 29–35.

31.

Anonymous. The new federal laws relating to foods, drugs, and cosmetics. Am J Public Health. 1938; 28: 1114–6.

32.

Anonymous. Public health aspects of the Federal Food, Drug, and Cosmetic Act. Am J Public Health. 1939; 29: 1292–6.

33.

Swann

J.P.

FDA and the practice of pharmacy: The history of prescription drug regulation before the Durham-Humphrey Amendment of 1951. Pharmacy in History. 1994; 36: 55–70.

34.

Marks

H.M.

Revisiting “The origin of compulsory drug prescriptions.”

Am J Public Health. 1995; 85: 109–15.

35.

Sherman

, Strauss

Thalidomide: A twenty-five year perspective. Food Drug Cosmetic Law J. 1986; 41: 458–66.

36.

Food and Drug Administration. Revocation of certain regulations; biological products. Fed Reg. 1996; 61: 40153–5.

37.

Cohen

L.P.

Many medicines are potent years past expiration dates. The Wall Street Journal. 2000; 233(Mar 28): 1.

38.

Buday

Fundamentals of US biological products regulation. Regulatory Affairs. 1991; 3; 223–39.

39.

Gamerman

G.E.

Regulation of biologics manufacturing: Questioning the premise. Food Drug Law J. 1994; 49: 213–35.

40.

Levine

A.N.

FDA Enforcement Manual. Washington, DC: Thompson Publishing Group; 1999.

41.

Banta

P.M.

Federal regulation of biologicals applicable to the diseases of man. Food Drug Cosmetic Law J. 1958; 13: 217–30.

42.

Over 75% of therapeutic firms, but only one-third of IVDs, pass team biologics audit. Pharmaceut Biotech Quality Control. 1999; 33(Nov): 1–4, 7–8.

43.

Parkedale turns to consultants after FDA halts Fluogen production. FDC Reports. 2000; 62(Mar 20): 27.

44.

FDA halts production of Parkedale's flu vaccine, letter claims violations of 1993 consent decree. FDA Enforcement Manual Monthly Bulletin. 2000; 9(May): 6–8.

45.

Abbott case reflects FDA focus on “medically necessary” product GMPs. FDC Reports. 2000; 62(Jan 3): 26.

46.

Wyeth DT vaccine seized by FDA; manufacturing upgrades underway. FDC Reports. 2000; 62(Jun 19): 29.

47.

Kurtzweil

Ex-Bard executives sentenced to prison. FDA Consumer. 1996(Dec): 1.

48.

Centeon ceases production for third time following GMP violations. FDC Reports. 1998; 60(Sep 14): 21.

49.

Grabenstein

J.D.

Pharmacists and immunization: Increasing involvement over a century. Pharmacy in History. 1999; 41(4): 131–46.

The Biologics Industry: How Federal Regulation Enhances Quality of Vaccine and Antibody Manufacture

Abstract

Objectives

Keywords

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References