Regulation of Compounding by the Food and Drug Administration

2010 ◽  
Vol 23 (5) ◽  
pp. 502-506 ◽  
Author(s):  
Karl G. Williams
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmacy Practice ◽  
Federal Regulation ◽  
Traditional Art ◽  
The Law ◽  
State Of Affairs

Federal regulation of the traditional art of pharmacy practice compounding is an unsettled area of the law and the profession. For many years, the Food and Drug Administration (FDA) was not interested in compounding. Attempts to regulate by FDA and Congress have caused difficulty within the profession, litigation with inconsistent results, and an unsettled state of affairs. There are a number of possible resolutions.

scholarly journals Regulation of E-Cigarettes in the United States and Its Role in a Youth Epidemic

Children ◽  
2019 ◽  
Vol 6 (3) ◽  
pp. 40 ◽  
Author(s):  
Mark Gottlieb
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Rapid Rise ◽  
Federal Regulation ◽  
Surgeon General ◽  
Cigarette Industry ◽  
If Current ◽  
The U.S

During the first decade of federal regulation of electronic nicotine delivery systems (ENDS), the e-cigarette industry has rapidly grown. Recently, the U.S. Surgeon General and Commissioner of the Food and Drug Administration each declared the rapid rise in rates of youth using these products to be an “epidemic.” While a foundational basis for regulating ENDS has been in effect since 2016, deferred enforcement has contributed to acute rise in use by youth. The Agency has undertaken several initiatives to address the problem and warned manufacturers that if current youth trends continue, it will be “game over.”

Food and Drug Administration Regulation of Orthotic Cranioplasty

2001 ◽  
Vol 38 (4) ◽  
pp. 337-340 ◽  
Author(s):  
Timothy R. Littlefield
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Class Ii ◽  
Treatment Programs ◽  
Federal Regulation ◽  
Deformational Plagiocephaly ◽  
New Device ◽  
Significant Challenge ◽  
Present Information ◽  
Orthotic Treatment

Objective: To present information regarding the current federal regulation of cranial orthotics used for the treatment of deformational plagiocephaly as well as to discuss concerns raised by the Food and Drug Administration regarding the safety and effectiveness of these devices. Background: Although first introduced in 1979, the use of orthotic helmets for the treatment of deformational plagiocephaly was slow to gain acceptance. However, with the recent increase in infants presenting with this condition, numerous orthotic treatment programs have been established throughout the country. Until recently, federal regulation of this “industry” was largely ignored. Regulation: In 1995 our office was served notice that our orthosis would require clearance from the FDA. Since the FDA had never approved a medical device of this kind, clearance presented a significant challenge. However, after 3 years of providing clinical data, clearance was finally granted, and a new device category known generically as “cranial orthosis” was created. A cranial orthosis is considered to be a Class II neurology device and requires both general and special controls in order to ensure its safety and effectiveness. Summary: Orthotics used for the treatment of deformational plagiocephaly are regulated by the FDA and are considered Class II neurology devices. Submission of a premarket notification (510[k]) is required prior to placing these devices on the market.

Cell Transplantation and Federal Regulation

1995 ◽  
Vol 4 (4) ◽  
pp. 411-414 ◽  
Author(s):  
Philip D. Noguchi
Keyword(s):  
Somatic Cell ◽  
Cell Transplantation ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Federal Regulation ◽  
Cell Therapies ◽  
Main Emphasis ◽  
Guidance Documents

Federal regulation of tissues and organs has proceeded slowly, with main emphasis on safety of the procured material. More recently with the development of somatic cell therapies, the Food and Drug Administration has issued some guidance documents that establish that some classes of cells that are manufactured will be subject to not only safety but efficacy requirements. Cell transplantation presents several aspects that are similar to somatic cell therapies, and the purpose of this presentation is to explore those relationships.

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