Lapas attēli
PDF
ePub

ADMINISTRATION,
DEPARTMENT OF HEALTH AND

HUMAN SERVICES

(Parts 200 to 299)

SUBCHAPTER C-DRUGS: GENERAL

Part 200 201 202 203 205

Page

5 8 72 81

93

206

General
Labeling
Prescription drug advertising
Prescription drug marketing
Guidelines for State licensing of wholesale pre-

scription drug distributors
Imprinting of solid oral dosage form drug products

for human use
Registration of producers of drugs and listing of

drugs in commercial distribution
Medication Guides for prescription drug products
Current good manufacturing practice in manufac-

turing, processing, packing, or holding of drugs;

98

207

99 109

208 210

general

113

211

115 135

216 225

136

226

Current good manufacturing practice for finished

pharmaceuticals
Pharmacy compounding
Current good manufacturing practice for medi-

cated feeds
Current good manufacturing practice for Type A

medicated articles
Special requirements for specific human drugs
Controlled drugs ......
Drugs used for treatment of narcotic addicts
Drugs; official names and established names

250 290 291 299

143 148 155 156 178

PART 200-GENERAL

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

pensers.

IMPORTANT

[merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][ocr errors][merged small]

IMPORTANT

CORRECTION

OF DRUG

INFORMATION

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

« iepriekšējāTurpināt »