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Related post: importation is not sufficient to assure the quality of those drugs. Two foreign drug manufacturers indicated that CGMP regulations had a significant impact on their operations. Another foreign manufacturer said their facilities were inspected annually by FDA with respect to antibiotic certification and new drug approvals. The act applies to drugs introduced into interstate commerce in the United States, including drugs imported from other countries. It does not, of course, apply to manufacturing of drugs in other nations if the drugs are not brought into the United States. Many foreign countries, however, have adopted requirements similar to CGMP regulations, and foreign manufacturers may be subjected to inspection by their own governments. International organizations such as the World Health Organization and the European Free Trade Association provide manufacturing standards and reciprocal agreements between participating countries. Overseas pharmaceutical manufacturers who export to the United States are inspected by FDA or under reciprocal inspection agreements as part of the new drug application approval process and antibiotic drug certification, and individual drug products are subject to intensive examination, including testing, before being allowed into the United States. If, for example, there is a question regarding the safety, identity, strength, quality, or purity of a drug product offered for import, FDA has authority to deny entry of the article unless factory inspection is permitted or inspectional information is available about those firms covered under reciprocal inspection agreements. The United State currently has reciprocal inspection agreements under which governments will exchange inspection information about domestic firms in lieu of conducting overseas inspections. These agreements are with Sweden, Switzerland, and Canada. Therefore, the Commissioner finds that there is adequate coverage of imported drugs to assure compliance with CGMP regulations. 45. Several comments referred to provisions in the Medical Device Amendments of 1976 and requested that FDA consider providing for exemptions from or variances to the CGMP regulations and special advisory assistance as Congress specifically mandated regarding FDA regulation of small manufacturers of medical devices. Along the same lines, a substantial number of comments were received from "small" drug manufacturers or organizations representing "small" drug manufacturers who strenuously oppose most of the proposed changes in the CGMP regulations. The tenor of the majority of the comments was that the proposed changes would seriously affect the initial and continuing costs of a "small" drug manufacturer but probably have little economic impact on, or could more easily be absorbed by, a "large" pharmaceutical manufacturer. Several comments expressed concern that generic drug manufacturers might be eliminated because they could not meet all the requirements of the proposed CGMP regulations and still compete in the marketplace. Arguments were presented that, because small manufacturers very often are involved with the manufacture of a small number of products (frequently less potent over-the-counter preparations) and almost by definition have small physical facilities, limited equipment, and few personnel, extensive formal quality control procedures are unnecessary to assure high quality of the drugs manufactured. One comment, apparently from a small manufacturer, agreed in principal with the proposed CGMP regulations, felt that size had very little to do with achieving good manufacturing practice, and offered comments on specific sections of the proposed CGMP regulations. The Commissioner rejects the contention that quality control procedures are unnecessary in the case of small firms; FDA's experience is that quality control procedures falling below those described in these regulations, in firms of great or small size, are often responsible for lack of drug product quality. The Commissioner also rejects the argument that less control need be exerted over so-called "less potent over-the-counter preparations," which respondents stated are often manufactured by small firms, for the reasons explained in paragraph 42(h) Buy Furazolidone above. The Commissioner believes that the final regulations will be no more burdensome for small manufacturers than for others. Many interpretations offered in comments on specific sections strongly suggested that the intent of the proposed regulations had been misunderstood. The language has been clarified in the final regulations. In other instances the requirements were reworded to provide for more flexibility for the varieties of procedures and controls that may be utilized by various manufacturers. The Commissioner does not believe a specific provision within the CGMP regulations for variances to these regulations is necessary for small manufacturers. A mechanism already exists, however, in 21 CFR 10.30 for firms to petition for variances to or amendments in any regulation when the requirements are not reasonably attainable. For many years FDA has conducted and participated in numerous seminars and workshops designed to assist drug firms in interpreting and carrying out the requirements of CGMP regulations. Additionally, the agency has made films and publications available that are also designed to assist drug firms in their efforts to comply. The agency is committed to continuing these voluntary compliance efforts especially designed to assist small businesses. 46. Several comments noted that the current good manufacturing practice regulations do not pertain to veterinary biological products. One respondent suggested that the section specifically state that these regulations apply only to human biological products. The Commissioner believes that the section as proposed clearly establishes applicability to pertinent biological drug regulations, but for consistency with references elsewhere in the CGMP regulations to human biological drug products, he is revising 210.2 to specifically include reference to biological drug products for human use. 47. Several comments requested clarification of the last sentence of 210.2 to show that conflicting or contradictory regulations would be superseded by the one specifically applicable to the drug product. The Commissioner finds that the proposed wording clearly states his intent. Certainly, in the case of conflicting or contradictory regulations, it will be impossible to Furazolidone Tablets comply with all regulations and the regulation that is specifically applicable to the drug product in question would apply. 48. A comment suggested that if medicated premixes are meant to be excluded from Part 210, then Part 226 should be specifically excluded. The meaning of this comment, as it relates to 210.2 is not clear. The Commissioner advises that Part 210 applies to all the regulations in Parts 211 through 229. 49. One person proposed that the term "drug product" be replaced with the words "commercial dosage form" to exempt drugs undergoing development from the requirements of these regulations. The Commissioner finds that, as stated in 211.1, these CGMP regulations apply to the preparation of any drug product for administration to humans or animals, including those still in investigational stages. It is appropriate that the process by which a drug product is manufactured in the development phase be well documented and controlled in order to assure the reproducibility of the product for further testing and for ultimate commercial production. The Commissioner is considering proposing additional CGMP regulations specifically designed to cover drugs in research stages. VII. DEFINITIONS The Commissioner received hundreds of comments regarding definitions. General comments are listed immediately below; comments regarding specific definitions follow in numerical order. 50. One respondent said this section is inconsistent because certain terms such as "drug" and "establishment" which are defined in the act are not defined here, while other terms which are defined elsewhere are also defined here. The Commissioner believes that the length of part 210 would be unnecessarily increased by including in this part the definitions of terms that are well known or already defined in the act. Other terms the meaning of which
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