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  1. Preparing For Fda Pre Approval Inspections: A Guide To Regulatory Success, Second Edition
  2. About this book
  4. PSC646 - Regulatory Science: Books

There had been multiple complaints on leaky and defective vials. If there is a quality or patient risk, that is also an issue. That points back to the quality unit and whether it was effective in carrying out its duties and responsibilities. The main thing for all these under number 1 is that quality is an umbrella of everything at a pharma company, no matter what system we are covering.

Preparing For Fda Pre Approval Inspections: A Guide To Regulatory Success, Second Edition

They should have oversight of everything going on in their facility. Patient safety is the number one priority. When I perform an inspection, I always ask myself if I would feel safe taking this product, if I would feel safe having my family taking this product. Moller presented a color-coded illustration of the top five citations issued over the last four fiscal years, along with the same data from FY for comparison, noting the similarities over time below.

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While major improvements have been made in industry over the years, we are seeing recurring themes. There is nothing more basic to GMP compliance than testing finished products and making sure they meet the specs, Czabaniuk said. Not too comfortable. And if it is a narrow therapeutic index drug or a sterile drug, we are going to take action quickly.

The second serious violation he singled out is not having procedures to prevent microbial contamination. There are a lot of controls that are required to make sure that the finished product is in fact sterile. That is another observation that would push a case to the violative category. Lastly, Czabaniuk cited issues with product stability. That means that the product that is in distribution is of an unknown quality. We would expect the firm to take prompt action to look at the quality of product in distribution.

Our expectation is that they would move quickly to develop stability-indicating methods. Other common findings, Moller pointed out, are in the area of data integrity in the laboratory. These include:. When the audit trail is turned off, it allows the analyst or the reviewer the potential to either change data, delete data, or move data to a folder that is not reviewed or does not go through the QA process. Lock it down. Food and drug law deals with governmental attempts to protect public health and individual welfare in the development and marketing of essential commodities.

The materials included in this Third Edition, the organization used, and the issues dealt with reflect this focus. The organization and bibliographic assistance should help frame the pertinent questions and identify many of the relevant sources. The FDA's continuing efforts to come to grips with its regulatory responsibilities comprise a mini-history of American administrative law. Since the 's, regulation of food, drugs, and related products has presented some of the most challenging illustrations of the tense interplay between law and science.

Because of the growing complexity of its responsibilities and the potential clash between public objectives, the FDA has been forced to experiment with a wide variety of innovative administrative procedures for deciding controversial law-science issues. The story of federal efforts. Reiss; Gary D. This book is designed to assist candidates in preparing for pharmacy law examinations in all states. Also includes over practice federal law questions and answers. B9 Law and Ethics for Pharmacy Technicians provides a comprehensive overview of pharmacy laws, regulations and ethics as they specifically relate to the purview and practice of the pharmacy technician.

The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed. Updated chapters include: advances in international regulatory requirements, including ICH guidelines and harmonization a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs the latest regulatory requirements for expediting new drug approvals strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development.

Drug development, the processes by which a chemical compound becomes a "drug" and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. Designing and monitoring studies, obtaining and analyzing scientific data, and reconciling clinical results against the ethical constraints and regulatory guidelines of government agencies, requires a complex interaction of in-house specialists and academic and commercial consultants worldwide. Scientific, technical, and tactical considerations play out in an environment where a balance must be struck between the often-competing interests of the corporation, its investors, government regulators, and the safety and well being of intended patients.

All the while, dwindling patent protections impose an ever-contracting timeframe for success. This proved to be difficult in many cases. For example, Lee Barlett, a former shirt salesman from Pittsburgh, promoted a medicine called Banbar, an extract of the horsetail weed, as an effective treatment for diabetes. The government took Barlett to court for selling a mis- branded drug. Elliott P. FIGURE 3 Pharmacologists in the Bureau of Chemistry employed biological assays to develop the first reference standards issued to industry to promote compliance with the testing requirements for select pharmaceuticals in USP X The defense offered hundreds of testi- monial letters on behalf of Banbar.

The jury found in favor of the defense, despite the fact that the government presented death certificates—attributed to diabetes— for individuals who had submitted these testimonials Under Wiley, enforcement of the Food and Drugs Act weighed heavily toward foods. Of the first actions taken by the bureau up to , fewer than one quar- ter dealt with drugs. And those drug actions typically addressed patent medicines; as seen earlier, false therapeutic claims were a driving force for action. Official drugs such as belladonna and asafetida were the subjects of fewer than of these actions.

Most defendants did not challenge the bureau, but rather paid their fines, adjusted their labeling, and continued to advertise as before, since the latter was beyond the reach of the law Carl Alsberg followed Wiley as chief chemist in , and he continued to favor foods. But he also focused more attention on ethical drugs. To address these, the bureau developed new analyses for crude drugs, and by the s bureau sci- entists pioneered biological assays for ergot, digitalis, and other drugs, which were adopted by the USP 75 Fig.

The bureau also monitored drugs dispensed by pharmacists in the District of Columbia believing state pharmacy boards were the more appropriate monitor elsewhere beginning in the s and found substantial deviations from official standards. By the early s, FDA and the APA reached an agreement as to what would be considered reasonable tolerances for dispensed drugs When Walter Campbell succeeded Alsberg in , he revitalized the drug regulatory effort, beginning with the appointment of George Hoover, a physician and chemist, to head drug regulation.

The bureau consequently expanded its inter- ests from crude drugs to tablets, discovering fairly wide variations from official standards. But by this time, when the Republicans came to power and the pol- icy was made to be more cooperative with business, court action began to be superseded by negotiation. The committees helped improve tableting technologies and negotiated with the bureau over allowable deviations from the labeled amount of active ingredient. But in the New Deal era, drug regulation took a less collaborative tone with industry Foods did not have standards, cosmetics and med- ical devices were unregulated, the penalties imposed by the law were paltry rel- ative to the crime, with the exception of the 11 ingredients there was no required listing of drug ingredients, factory inspections—although interpreted and executed by the bureau as warranted under the law—were not explicitly authorized, and although the law prohibited a food that was made to be unsafe, there was no sim- ilar protection for drugs.

By the s, and increasing considerably after Franklin Roosevelt became president in , FDA began to publicize rather creatively the more egregious examples of deceptive and hazardous products that were on the market and perfectly within the law, an argument for a new comprehensive law Months after the introduction of the wonder drug sulfanilamide, the S. Massengill Com- pany of Bristol, Tennessee, began investigating a liquid dosage form for the drug. Their investigation consisted of finding a solvent in which the drug would dis- solve sulfanilamide was known to be stubbornly insoluble and flavoring and coloring the preparation so as to be especially useful for children and others not inclined toward tablets.

Quality control amounted to little more than an organolep- tic appraisal. Harold Watkins, the company chemist, selected diethylene glycol as the vehicle for the sulfa without testing the solvent or even examining the medical literature. He did not bother testing it himself, he claimed, because glycols were related to glycerin, which had long been used in medicines. The company thus began shipping its Elixir Sulfanilamide from Tennessee and its Kansas City office in early September. On October 11, a representative from the Tulsa County Medical Society con- tacted the AMA to inform them that several deaths in the Oklahoma county appeared to be associated with the Massengill product.

Neither Elixir Sulfanilamide nor any Massengill product had ever been accepted by the Council. FDA learned that the Elixir was involved in all the Tulsa fatalities, at which point the agency dis- patched its chief medical officer and one of its finest field investigators to Bristol to investigate. They learned that proprietor Samuel E. Massengill issued an inadequate recall notice and that gallons remained unaccounted for. FDA dedicated virtually its entire field force to tracking down the remaining product—although forced to rely on a technical error for legal cause.

Nothing in the act prohibited unsafe drugs. Rather, FDA was allowed to seize Elixir Sul- fanilamide because it was misbranded; an elixir, by definition, had to employ alco- hol, and the Massengill medicine of course had none. Most physicians and phar- macists encountered by FDA investigators during the frantic recovery effort were helpful, but some were uncooperative and even obstructive, no doubt to deflect per- sonal responsibility and liability.

Much was recovered from warehouses, pharmacy shelves, and medicine cabinets, but overall, Elixir Sulfanilamide killed at least , mostly in the South. Many were children, such as the 6-year-old girl from Tulsa who perished in this ordeal Fig. Roosevelt that little voice is stilled.

  1. Pharma guidelines book?
  2. Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics – Dattani Book Agency.
  3. Dynamical zeta functions for piecewise monotone maps of the interval;

The first time I ever had occasion to call in a doctor for her and she was given the Elixir of Sulfanilamide. Tonight our little home is bleak and full of despair. Even the memory of her is mixed with sorrow for we can see her little body turning to and fro and hear that little voice screaming with pain and it seems as though it drives me insane.

Tonight President Roosevelt as you enjoy your little grandchildren of whom we read about, it is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind. The bills to correct the gaps in the act had been delayed and diluted over the previous 5 years. However, the impact of the Elixir Sulfanilamide tragedy was to strengthen the drug provisions of the latest bills and in fact propel passage of the law itself. Roosevelt signed the bill on June 25, The premarket provision, inspired by the fear of another Elixir Sulfanilamide disaster, had an immediate impact, with over new drug applications filed in the first 9 years and 13, by This excerpt from a moving letter to President Roosevelt from Mrs.

Nidiffer of Tulsa describes her anguish and helplessness over the loss of her 6-year-old daughter, Joan Marlar. Do not take more than the dosage recommended. For example, the use of a sulfa drug in a venereal disease was hardly routine, complicated as it was by both the adverse reactions that many of the early sulfas produced and the identification and progress of the disease. In other words, FDA ruled that in some cases medi- cal expertise had to be involved in the medication process for the drug to be safe.

The agency identified an increasing number of drugs that had to be labeled for dis- pensing only on the order of a physician or dentist; the birth of another standard of modern medicine, the prescription drug 87— This created confusion about how a drug would be categorized—prescription or nonprescription—and who would have primary responsibility for that designation. The absence of statutory direction was resolved in when the Durham—Humphrey Amendment was passed. That law established broad parameters for deciding which drugs merited designation as prescription legend status and which could be available over the counter At first the agency focused on pharmacies, some of which were either selling these drugs over the counter without a prescription or incessantly refilling old prescriptions that did not authorize any refills.

Eventually many other drugs prone to abuse, such as hallucinogens, were consolidated for special interdiction by FDA under the Drug Abuse Control Amendments of 93, The introduction of the sulfa drugs, beginning with sulfanilamide in , launched a revolution in chemotherapy. Statutes and regulations did their best to keep track of new therapies. As additional antibiotics were discovered, laws were passed to accommodate them 96— As mentioned earlier, companies flooded FDA with drug applications at the outset.

The agency received an average of over NDAs monthly from to because sponsors were apparently unsure of what constituted a new drug. NDA , received on August 30, and approved on September 20, , was for 4-H Household Cough Syrup, consisting of horehound, molasses, and vinegar. Interestingly, in January the agency ruled that the indications for aspirin were so well known to consumers that directions for use were not required. The application submission rate slowed during World War II and the early postwar years to about annually.

However, it picked up again in the s to approximately each year, when research funds flooded laboratories almost as fast as pathbreaking new medicines flooded the marketplace. This source of funding, together with strong congressional support, launched in full force the modern era of autonomously peer- reviewed extramural funding of biomedical research at NIH In addition, the pharmaceutical industry accelerated a trend that began in the period between the wars, pouring more and more revenue into research and devel- opment , That decision might have been made a little easier by the suc- cess of their wartime experience with penicillin, synthetic anti-infective agents, and other drugs.

Thus, a host of antibiotics, diuretics, ataractics, corticosteroids, anti- spasmodics, and other classes of drugs proliferated during that decade , Of course, the number of supplements grew as the base number of NDAs increased. And then there were some drugs that yielded scores or even hundreds of NDAs, such as diethylstilbestrol and rauwolfia serpentina. David Cavers reports that the latter led to applications from different firms and was included in different medicines The idea of federally man- dated effectiveness in medicines was nothing new at this time.

This formalized a policy that had been in place for years. The Insulin Amendment, Peni- cillin Amendment, and the other antibiotic amendments literally invoked efficacy as a prerequisite for certification by FDA. Reviews of certain NDAs that claimed to treat serious diseases such as pneumonia certainly took efficacy into account The Hepasyn story began in the early s, when various researchers observed that cancerous tissue bore a high concentration of the amino acid, argi- nine, which appeared to promote cell division in tumors.

Some tried to exploit this observation by applying the liver enzyme arginase, which helps to hydrolyze arginine, as a possible treatment to control tumor growth. Success was fleeting for most. However, dentist Wesley G. Pharmacy and Dentistry at the University of California at San Francisco in the s, claimed to have success treating animal tumors with arginase.

In November , the school arranged with a Hollywood clinician to test arginase, and within a year patients had received the substance. Eventually, the Holly- wood physician began treating other cancer patients on an ambulatory basis once a week at the mortuary school. The story became even more curious after Irons and the school parted company, but the San Francisco school submitted an NDA late in FDA inspectors visited the mortuary school and found serious production problems, such as organoleptic sterility testing.

The NDA contained results for only 10 patients, although the sponsors claimed to have data on patients. FDA, not surprisingly, considered the application incomplete and requested more data. As problematical as the manufacturing operation was, FDA chose to focus on the clin- ical evidence submitted by the college Fig. By October , the application was deemed complete enough for a review. The Hepasyn review thus was not going to be just another NDA evaluation. Rather, it was to be a blatant stand on therapeutics and the law. While there was not a surfeit of bona fide treatments for the cancers Hepasyn claimed to bene- fit, there certainly were some.

An approved yet ineffective Hepasyn, the reasoning went, would lead some patients to delay or possibly avoid treatment with estab- lished effective treatments. Larrick informed the mortuary school that if the NDA were not withdrawn, a hearing notice—as provided in the act to sponsors who wished to petition adverse NDA decisions by FDA—would be issued next month. FDA had another chance to press the safety-efficacy policy a few years later, and this time the drug firm was more accommodating.

FDA used this opportunity to press for a formalized policy mandating an efficacy requirement in some drugs. Among other issues, FDA believed there were insuffi- cient reports in the application from experts in the treatment of infectious diseases, and certain claims would have required unattainable plasma levels even at triple the recommended dosage. The agency did not explain why these issues were not apparent at the time of the application. Eaton Laboratories submitted additional data, but FDA said that evaluation of those data should be done in the venue of a formal hearing over suspension of the Altafur NDA; its lack of effectiveness did not justify its toxicity.

The hearing began in January and lasted several weeks. Fellow Democrat Warren Magnuson of Washington had heard complaints from constituents and also learned about the rising cost of drugs in America as a member of the Labor, Health, Education, and Welfare Subcom- mittee. But Kefauver, chairman of the Subcommittee on Antitrust and Monopoly since January , was in a position to explore this development in depth. Thus, in December , following an extensive investigation by his staff that began the previous year, Kefauver initiated hearings into administered prices in the pharma- ceutical industry.

How to prepare for an FDA inspection

The early testimony provided some headline-grabbing statistics into how the pharmaceutical industry arrived at drug prices. For example, the com- mittee learned that the German firm Schering had purchased bulk estradiol progy- non for symptoms associated with menopause from Roussell of France for resale in the United States. The Schering president objected that such a hyperbolic fig- ure ignored the costs of manufacturing, advertising, distribution, and research on this drug.

Kefauver replied that Schering would have incurred no research costs for this Roussell drug itself. When the hearings shifted into a study of drug costs as a function of research expenses in the industry, A. The hearings thus took on another dimension by investigating advertising practices of the pharmaceutical industry and the delivery of information about their drugs to doctors.

Records sub- poenaed by Kefauver from the 22 largest firms revealed that in they expended an average of one-fourth of their gross income on advertising. Investment in detail men represented a considerable portion of that expense, as estimates for the same year indicated a detail force for the industry of 15,, or one for every 10 doctors The committee also heard about the relationship between FDA and the phar- maceutical industry.

Former FDA medical officer Barbara Moulton described an acquiescent agency, frequently and inappropriately deferring to the wishes of firms. Kefauver first addressed patents in his bill, severely curtailing the monopoly that drug companies would have on their products an outgrowth of another facet of the hearings. The bill also gave FDA increased authority over drug produc- tion, distribution, and advertising. Advertising would include explicit and prominent warn- ings, again responding to problematical issues during the hearings. The drug clearance provision of the act, in which a drug application became effective after 60 days unless prevented by specific FDA action, would be ended under this bill.

Finally, sponsors would have to show drugs to be effective as well as safe Opposition emerged quickly. The AMA, for example, came out strenuously opposed to the effectiveness requirement, arguing that only the physician can make a determination if a drug works or not.

The support of the White House was tepid at best On September 12, , the William S. Merrell Company of Cincinnati sub- mitted an application for Kevadon, known generically as thalidomide. Merrell was the U. The application was routed to Frances Kelsey, who had replaced Barbara Moulton. However, Kelsey found the chronic toxicity data inadequate to support the safety of the drug and the label- ing unsuitable.

Merrell continued to append data to the application, which Kelsey continued to find inadequate to the task. The contacts between Merrell and Kelsey or her superiors thereafter occurred almost weekly until the spring, as the firm was rushing to make March 1 launch date for Kevadon. But crucial news emerged in February , when the medical officer read a report in the December issue of the British Medical Journal that associated long-term use of thalidomide with peripheral neuritis.

When representatives from Merrell met with Kelsey in May to discuss this revelation which Merrell believed rather inconsequential, assuming the effects were reversible , Kelsey requested evi- dence that Kevadon would be safe in pregnancy. Merrell and outside clinical investigators representing the company continued to argue that Kevadon was effective and safe relative to the barbiturates, the firm now hoping to meet a November launch in time for the holidays.

On the last day of that month, Merrell reported to Kelsey that thalidomide had been withdrawn from Germany, where use of the drug had been correlated with severe congenital abnormalities. The United States narrowly escaped the fate of many other countries. Over doctors received Kevadon the agency had assumed from three to six dozen investigators were involved , and the investigation involved about 20, patients, of whom were pregnant. Seventeen cases of thalidomide-induced phocomelia occurred in the United States, seven of which were documented to be caused by thalidomide obtained outside the Merrell study — The shock of what might have happened with thalidomide wrested the drug regulation reform bill from congressional inertia, and President Kennedy, sur- rounded by Kefauver, Kelsey, and others, signed the bill into law on October 10, Fig.

Although much had changed in the bill Kefauver introduced, still some elements remained. Attempts to cut costs via patent adjustments were long gone, as was the biologics-like system of licensing although firms had to register. Manufacturers had to prove that their drugs were effective as well as safe—not just drugs introduced from that point forward, but all new drugs introduced since Safety, effectiveness, and reliability of a drug would be further provided for by requiring that production adhere to current good manufacturing practice, although that provision was made clear in FDA regulations as far back as the early s And finally, drug inspectors.

Among those looking on is Frances Kelsey, standing second from left. But subsequent laws and regulations stand out, too, for many reasons. For example, the rise in the consumer movement certainly had an impact on drug regulation. The Vitamins and Minerals Amendment Proxmire Amendment of , which prevented FDA from limiting potency of supplements or regulating them as drugs, was due in no small part by organized efforts of consumers to inundate their members of Congress and FDA with letters of protest on a scale unheard of at that time , The National Organization for Rare Disorders led the effort behind the Orphan Drug Act of to persuade pharmaceutical companies to develop drugs, otherwise unprofitable, for diseases with small patient populations , However, there were several restrictions to treatment INDs, such as the need to have a firm request treatment IND status, to be treated by a physician skilled in ther- apy of that disease, and to have no other therapies available.

Activists representing HIV and AIDS victims, families, and friends engaged FDA directly on this issue and helped not only to relax these restrictions but also to refocus the overall drug development and evaluation process. FDA thereafter would consult with sponsors to plan more efficient clinical studies of drugs for life-threatening and severely debilitating diseases, modeled on the testing and evaluation of AZT zidovudine approved in for patients with HIV , Individuals would be allowed to return to the country with a 3-month supply of any drug desired as long as the agency ensured that the product was not fraudulent, counterfeit, or harm- ful, and if the traveler presented the name and address of the physician responsible for the treatment.

The history of drug regulation has come full circle, from the second decade of the 19th century, when a Maryland physician persuaded Congress to pass a law to ensure genuine smallpox vaccine, to the first decade of the 21st century, when the United States again faced smallpox vaccination as a policy issue.

About this book

In between we have witnessed a vast array of stimuli to changes in the way drugs are reg- ulated. Therapeutic disaster and concomitant outrage, of course, are perhaps the most visible sources for tectonic shifts in policy. FDA often refers to itself as a science-based regulatory agency, but the context for drug regulation over the past years has been and will always be much broader than science and law. Wedderburn AJ. Bulletin 42, Division of Chemistry, U. Department of Agriculture. Sonnedecker G, Urdang G.

Legalization of drug standards under state laws in the United States of America. Food Drug Cosmetic Law J ; — Food and Drug Law: Cases and Materials. Westbury, NY: Foundation Press, — quote from p. Pharmacopoeia of the United States of America. Boston, MA: Charles Ewer, Sonnedecker G. The founding period of the U. European antecedents. Pharm Hist ; — A national movement emerges. The first edition. Anderson L, Higby GJ. Quoted in Ridgway C. Good Enough for America! The Drug Import Law of Cited in: Young JH.

Pure Food, pp. Congressional Globe. Drug Import Act. Pub L No. Stat , June 26, quote is from Sec 1. Okun M. Contributions of the pharmaceutical profession toward controlling the quality of drugs in the nineteenth century. In: Blake JB, ed. Dowling HF. Fighting Infection: Conquests of the Twentieth Century. Lechevalier HA, Solotorovsky M. Three Centuries of Microbiology.

Treasury Department, Marine Hospital Service. Annual Report of , — Kondratas RA. Biologics control act of Congress, House. Sale of Viruses, Etc. Report No. Biologics Control Act. Stat , July 1, Perhaps it is more accurate to say that any charges brought under the act or under its consolidation in the Public Health Service Act were not contested.

The suit brought by the government against John P. Calise and the Westchester Blood Bank in for altering expiration dates appears to be the first litigated case of any kind under the Biologics Act. Solomon JM. Legislation and regulation in blood banking. In: Schaeffer M, ed. Federal Legislation and the Clinical Laboratory. Boston, MA: G. Hall, Hutt PB, personal communication, September 12, , who suspects that Calise might have been the first case. Biologics Control Act of Annual Report of the Surgeon-General of the U. Stat —, June 18, Stat , March 2, Young JH.

Kebler LF. Public health conserved through the enforcement of postal fraud laws. Am J Public Health ; — Medical Messiahs, pp. Wheeler-Lea Amendments. Stat , March 21, Handler M. The control of false advertising under the Wheeler-Lea act. Law Contemp Problems ; — Fishbein M. A History of the American Medical Association. Philadelphia, PA: W. Saunders, —, — Smith A.


The council on pharmacy and chemistry and the chemical laboratory. In: Fish- bein. American Medical Association, pp. Burrow JG. The prescription drug policies of the American Medical Association. In: Blake. Safeguarding the Public, pp. Starr P. The Social Transformation of American Medicine.

PSC646 - Regulatory Science: Books

Marks H. Council on pharmacy and chemistry and the chemical laboratory, pp. Smith AE. The council on pharmacy and chemistry. J Am Med Assoc ; ff. Knopf, — It was more than a possibility; see the case of Clarin heparin potassium , as discussed in U. Drug Industry Antitrust Act.

Hearings pursuant to S. Bishop J. Drug evaluation programs of the AMA, — J Am Med Assoc ; — New program of operation for evaluation of drugs. J Am Med Assoc ; — The impact of the new drug laws on the council on drugs of the American Medical Association. Clin Res ; — Weikel MK. Cowen DL. The role of the pharmaceutical industry.

Safeguarding the Public, p. Liebenau J. Swann JP. Madison JH. Eli Lilly: A Life, — Indianapolis: Indiana Historical Society, , Nelson GL, ed. Pharmaceutical Company Histories. Bismarck, ND: Woodbine, ; A case unresolved: Mrs. George vs. Hand and his colic cure. The best source on the history of patent medicines remains Young JH. Wiley typically emphasized the problem of food adulteration as a more serious public health issue than drug adulteration, perhaps in part because of his scientific interests.

On Wiley and his time, see Wiley HW. An Autobiography. Indianapolis: Bobbs-Merrill, Anderson OE. The Health of a Nation: Harvey W. Wiley and the Fight for Pure Food. Pure Food. Food and Drugs Act of Stat , June 30, Thackray A, et al. Chemistry in America, — Historical Indicators. Dordrecht: D. Reidel, — For bibliographic information on the variety of regulations issued by the bureau at this time, see A Guide to Resources on the History of the Food and Drug Administration: Published Primary Sources: Sources on Regulation and Enforcement. Sellers A, Grundstein ND.

Safeguarding the public, p. Sellers, Grundstein. Administrative Procedure and Practice. Sherley Amendment of Stat , August 23, Lamb RdeF. American Chamber of Horrors. Young: Drugs and the Law, pp. FDA and the practice of pharmacy: prescription drug regulation to Pharm Hist 57—59, Drugs and the Law, pp. Bull Hist Med ; — Food and Drug Legislation in the New Deal.

Sulfanilamide and diethylene glycol. American Chemical Society Symposium Series Elixir of Death. Food, Drug, and Cosmetic Act. Stat , June 25, A recent article has shed light on this provision of the act, largely forgotten by those who would believe a requirement for good manufacturing practices began in or even later.

Cooper DE. Adequate controls for new drugs: Good manufacturing practice and the federal food, drug, and cosmetic act. Cavers DF. The evolution of the contemporary system of drug regulation under the Act. Warning Statements for Drug Preparations. TC, November 1, Marks HM. FDA and the practice of pharmacy. To Distributors of Sulfanilamide and Related Drugs. TC-1, August 26, Reproduced in: Kleinfeld, Dunn. Federal Food, Drug, and Cosmetic Act, p. The generalization about prescription drugs applies, of course, only to nonnarcotic drugs. Stat , October 26, The illegal trade in amphetamines and barbiturates in the trucking industry received dra- matic treatment on television in the early s: Independence SW.

Drug Abuse Control Amendments of Stat , July 15, Drug abuse control under FDA, — Public Health Rep ; — Insulin Amendment of Stat , December 22, Penicillin Amendment of Stat , July 6, Streptomycin Amendment. Stat 11, March 10, Aureomycin Amendment of