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(Parts 200 to 299)
SUBCHAPTER C-DRUGS: GENERAL
Part 200 201 202 203 205
5 8 72 81
scription drug distributors
for human use
drugs in commercial distribution
turing, processing, packing, or holding of drugs;
Current good manufacturing practice for finished
250 290 291 299
143 148 155 156 178
Subpart A-General Provisions
Sec. 200.5 Mailing of important information
about drugs. 200.7 Supplying pharmacists with indica
tions and dosage information. 200.10 Contract facilities (including con
sulting laboratories) utilized as extramural facilities by pharmaceutical man
ufacturers. 200.11 Use of octadecylamine in steam lines
of drug establishments. 200.15 Definition of term "insulin”.
as prescribed by this section and not to use the distinctive envelopes for ordinary mail.
(a) Use first class mail and No. 10 white envelopes.
(b) The name and address of the agency or the drug manufacturer or distributor is to appear in the upper left corner of the envelope.
(c) The following statements are to appear in the far left third of the envelope front, in the type and size indicated, centered in a rectangular space approximately 3 inches wide and 244 inches high with an approximately 3/8 inch-wide border in the color indicated:
(1) When the information concerns a significant hazard to health, the statement:
Subpart B [Reserved]
Subpart C-Requirements for Specific
Classes of Drugs 200.50 Ophthalmic preparations and dis
The statement shall be in four lines, all capitals, and centered. “Important” shall be in 36 point Gothic Bold type. “Correction,” “Of Drug,” and “Information” shall be in 36 point Gothic Condensed type. The rectangle's border and the statement therein shall be brown.
tion (NDA) or to the sponsor of an Investigational New Drug (IND) Application, any information obtained during the inspection of an extramural facility having a specific bearing on the compliance of the manufacturer's, applicant's, or sponsor's product with the Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration's position is that by the acceptance of such contract work, the extramural facility authorizes such disclosures.
(d) The Food and Drug Administration does not consider results of validation studies of analytical and assay methods and control procedures to be trade secrets that may be withheld from the drug manufacturer by the contracted extramural facility. [40 FR 13996, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29, 1990]
g 200.? Supplying pharmacists with in
dications and dosage information. There are presently no regulations under the Federal Food, Drug, and Cosmetic Act that prevent a manufacturer of prescription drugs from sending the pharmacist data he needs on indications and dosage in exercising his important professional function of checking against possible mistakes in a prescription. The Food and Drug Administration believes manufacturers should be encouraged to supply such printed matter to the pharmacist for his professional information. Obviously, such printed matter should not be displayed to prospective purchasers to promote over-the-counter sale of prescription drugs.
8 200.11 Use of octadecylamine in
steam lines of drug establishments. The Food and Drug Administration will not object to the use of octadecylamine in steam lines where the steam may be used for autoclaving surgical instruments and gauze if the octadecylamine in the steam is not more than 2.4 parts per million.
$ 200.15 Definition of term "insulin."
For purposes of sections 801 and 802 of the act and this title, the term insulin means the active principle of the pancreas that affects the metabolism of carbohydrates in the animal body and which is of value in the treatment of diabetes mellitus. The term includes synthetic and biotechnologically derived products that are the same as, or similar to, naturally occurring insulins in structure, use, and intended effect and are of value in the treatment of diabetes mellitus.
$ 200.10 Contract facilities (including
consulting laboratories) utilized as extramural facilities by pharma
ceutical manufacturers. (a) Section 704(a) of the Federal Food, Drug, and Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory, warehouse, or establishment in which prescription drugs are manufactured, processed, packed, or held.
(b) The Food and Drug Administration is aware that many manufacturers of pharmaceutical products utilize extramural independent contract facilities, such as testing laboratories, contract packers or labelers, and custom grinders, and regards extramural facilities as an extension of the manufacturer's own facility.
(c) The Food and Drug Administration reserves the right to disclose to the pharmaceutical manufacturer, or to the applicant of a new drug applica
[63 FR 26698, May 13, 1998]
Subpart B [Reserved]
Subpart C-Requirements for
Specific Classes of Drugs $ 200.50 Ophthalmic preparations and
dispensers. (a)(1) Informed medical opinion is in agreement that all preparations offered