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this section. Also, if the Commissioner considers that investigations other than examination of such samples are necessary to determine whether or not such batch complies with the requirements of $ 431.10 for the issuance of a certificate, the fee shall include the cost of such investigations.

(f) The unearned portion of any advance deposit shall be refunded to the depositor upon his application.

(g) Whenever in the judgment of the Commissioner the ratio between fees collected (which are based upon experience and the best estimate of costs and the best estimate of earnings) and the costs of providing the service during an elapsed period of time, in the light of all circumstances and contingencies, warrants a refund from the fund collected during such period, he shall make ratable refunds to those persons to whom the services were rendered and charged, except for those services described under $ 433.12 of this chapter.

(h) All deposits and fees required by the regulations in this chapter, shall be paid by money order, bank draft, or certified check drawn to the order of the Food and Drug Administration, collectible at par at Washington, DC. All such deposits and fees shall be forwarded to the Food and Drug Administration, Department of Health and Human Services, Accounting Branch (HFA-120), 5600 Fishers Lane, Rockville, MD 20857, whereupon after making appropriate records thereof they will be transmitted to the Chief Disbursing Officer, Division of Disbursement, Treasurer of the United States, for deposit to the special account “Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration."

showing each shipment and other delivery (including exports) of each certified batch or part thereof by such person or by any person subject to his control. Such records shall show the date and quantity of each such shipment or delivery and the name and post-office address of the person to whom such shipment or delivery was made, and shall be kept for not less than 3 years after such date.

(b) Upon the request of any officer or employee of the Food and Drug Administration, or of any other officer or employee of the United States acting on behalf of the Secretary, the person to whom a certificate is issued shall at all reasonable hours make such records available to any such officer or employee and shall accord to him full opportunity to make inventory of stocks of such batch on hand and otherwise to check the correctness of such records.

$ 431.62 Records retention.

At the option of the person having control of records required to be kept by any regulation in this part 431, photostatic or other permanent reproductions may be substituted for such records after the first 2 years of the holding period.

Subpart D-Confidentiality of

information

[39 FR 18934, May 30, 1974, as amended at 40 FR 13497, Mar. 27, 1975; 40 FR 28052, July 3, 1975; 41 FR 2384, Jan. 16, 1976; 41 FR 18291, May 3, 1976; 44 FR 67113, Nov. 23, 1979; 45 FR 16471, Mar. 14, 1980; 46 FR 16677, Mar, 13, 1981; 46 FR 60578, Dec. 11, 1981; 46 FR 61071, Dec. 15, 1981; 50 FR 19918, May 13, 1985; 55 FR 11582, Mar. 29, 1990)

$ 431.70 Confidentiality of data and in

formation in an investigational new

drug notice for an antibiotic drug. (a) The existence of an IND notice for an antibiotic drug will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged.

(b) The availability for public disclosure of all data and information in an IND file for an antibiotic drug shall be handled in accordance with the provisions established in $314.430 of this chapter.

(c) Notwithstanding the provisions of $314.430 of this chapter, the Food and Drug Administration shall disclose upon request to an individual on whom an investigational antibiotic has been used a copy of any adverse reaction report relating to such use.

Subpart c-Records and Reports

8 431.61 Records of distribution.

(a) The person who requested certification shall keep complete records

[39 FR 44655, Dec. 24, 1974, as amended at 50 FR 7517, Feb. 22, 1985]

PART 432-PACKAGING AND LABELING OF ANTIBIOTIC DRUGS

Sec. 432.1 Packaging requirements. 432.5 Labeling requirements. 432.9 Labeling of antibiotic drugs intended

for export. 432.20 Declaration of potency.

AUTHORITY: 21 U.S.C. 321, 331, 352, 353, 357, 371, 381.

CROSS REFERENCE: For other regulations in this chapter concerning antibiotic drugs exempted from certain labeling requirements, see also $ 201.150 of this chapter.

a volume in excess of that designated, which excess shall be sufficient to permit the withdrawal and administration of the labeled quantity or volume, whether administered in single or multiple doses.

(c) If it is dispensed as a tablet, capsule, troche, pellet, or suppository, it may be enclosed in a foil or plastic film and such enclosure is a tight container as defined by the U.S.P., except for the provision that it shall be capable of tight reclosure. The immediate container may contain a dessicant separated from the drug by a plug of cotton or other like material.

(d) If it is dispensed as an ointment or cream, it shall be in collapsible tubes that shall in no case be larger than the 2-ounce size, except:

(1) If it is labeled for institutional use, it may be packaged in immediate containers larger than the 2-ounce size and it may be packaged in immediate containers of glass or plastic; or

(2) If it is an ointment represented for ophthalmic use, it shall be in collapsible tubes which shall not be larger than the 1/8-ounce size.

(e) If it is intended for ophthalmic use, the closure shall be one through which a hypodermic needle cannot be introduced

(39 FR 18938, May 30, 1974, as amended at 42 FR 44225, Sept. 2, 1977; 44 FR 10377, Feb. 20, 1979]

8 432.1 Packaging requirements.

Each antibiotic drug subject to certification under section 507 or 512(n) of the act shall be packaged in immediate containers which shall be of such composition as not to cause any change in the strength, quality, or purity of the contents beyond any limits therefor in applicable standards, except that minor changes so caused that are normal and unavoidable in good packaging, storage, and distribution practice shall be disregarded. The immediate containers shall be tight containers as defined by the U.S.P., except that if the antibiotic drug is dispensed as an ointment or cream, the immediate containers shall be well-closed containers as defined by the U.S.P. If the antibiotic drug is packaged for dispensing, it may be packaged in combination with a container of a suitable and harmless diluent approved by the Commissioner.

(a) If it is a sterile preparation, the containers shall be sterile at the time of filling and closing and shall be so sealed that the contents cannot be used without destroying the seal.

(b) If it is intended for parenteral use and the container is glass, it shall be transparent and colorless or light-resistant as defined by the U.S.P. The containers are closed either by fusion or by application of suitable closures, in such manner as to prevent contamination or loss of content. Multiple-dose containers are closed by a substance through which a hypodermic needle may be introduced and withdrawn without removing the closure or destroying its effectiveness. Each container shall be filled with a quantity of

$ 432.5 Labeling requirements.

(a) If an antibiotic drug is packaged for dispensing:

(1) It shall be labeled in accordance with the requirements prescribed by $201.100 of this chapter, issued under section 502(f) of the act, unless the regulations pertaining to such drug specifically exempt it from such requirements.

(2) Its labeling shall bear any additional information required for the drug by specific regulations.

(3) Each package shall bear on its outside wrapper or container and the immediate container an expiration date prescribed for the drug by specific regulations; except that in lieu of the expiration date prescribed by specific regulations, a date may be used that is 12, 18, 24, 30, 36, 42, 48, 54, or 60 months after the month during which the batch was certified if the person who requests certification has submitted to the Commissioner results of tests and assays showing that such drug as prepared by him is stable for such period of time. If the specific regulation does not stipulate an expiration period, it shall be as prescribed by this section. If the manufacturer or repacker of the drug has been exempted from the certification requirements, such date shall be the number of months after the month during which the batch was last assayed and released by the manufacturer or repacker. If an expiration date is used that is longer than the minimum date provided for the drug by specific regulations, it may be used only if the manufacturer has submitted information to the Commissioner adequate to prove that the drug is stable for such time.

(b) If it is packaged solely for manufacturing use or for repacking, each package shall bear on its outside wrapper or container and the immediate container, the following:

(1) The number of units micrograms of activity per milligram or per gram, and the number of grams or kilograms in the immediate container.

(2) The batch mark.

(3) The statement “Caution: Federal law prohibits dispensing without prescription."

(4) The statement "For manufacturing use,” "For repacking," or "For manufacturing use or repacking,” and, if it is not sterile, the statement "nonsterile."

(5) The required expiration date.

(c) The expiration date prescribed for a drug by the regulations in this chapter may be omitted from the label of the immediate container if such container contains a single dose and it is packaged in an individual wrapper or container that bears the date prescribed.

the labeling requirements of the applicable sections if the labeling used for such drugs meets the following conditions:

(1) It has been approved before use by the Government authorities of the country to which the drugs are intended for export; and

(2) Such labeling represents that such drugs are for use only in those conditions for which they are certified for domestic distribution.

(b) The legend "Caution: Federal law prohibits dispensing without prescription” might be inappropriate on antibiotic drugs exported from the United States, since their sale may or may not be so restricted under the laws of the country of destination. The Food and Drug Administration would not object to a slight modification of the wording to read, “Caution: Federal (U.S.A.) law prohibits dispensing without prescription," by a manufacturer who wishes to market a drug under the same label both in domestic and foreign commerce.

or

(39 FR 18938, May 30, 1974, as amended at 40 FR 13497, Mar. 27, 1975)

$ 432.20 Declaration of potency.

Wherever the potency of an antibiotic drug included in the regulations in this chapter is expressed in terms of weight, such potency shall be equivalent to that contained in the same weight of the master standard of the drug.

[39 FR 18938, May 30, 1974, as amended at 40 FR 13497, Mar. 27, 1975)

PART 433-EXEMPTIONS FROM AN

TIBIOTIC CERTIFICATION AND LABELING REQUIREMENTS

Subpart A-General Provisions

[39 FR 18938, May 30, 1974, as amended at 40 FR 13497, Mar. 27, 1975)

8 432.9 Labeling of antibiotic drugs in

tended for export. (a) Antibiotic drugs subject to certification under section 507 of the act and intended for export will be certified notwithstanding failure to meet

Sec. 433.1 Exemption of antibiotic drugs for

human use from batch certification re

quirements. 433.2 Conditions on the effectiveness of ex

emptions of antibiotic drugs for human use from batch certification require

ments. 433.3 Assay requirements for antibiotic

drugs exempted from certification.

Subpart B-Exemptions for which an

Application or Notice is required

433.12 Exemption for labeling. 433.13 Exemption for manufacturing use. 433.14 Exemption for storage. 433.15 Exemption for processing. 433.16 Exemption for repacking. 433.17 Exemption for investigational use.

Subpart C-Specific Use Exemptions

433.20 Antibiotic drugs for isolation and dif

ferentiation of microorganisms in clini

cal use. 433.21 Antibiotics for diagnostic use. 433.22 Biologic drugs that contain anti

biotics as a preservative. 433.23 Microbiological culture media con

taining antibiotics. 433.24 Exemption of antibiotic drugs for use

in teaching, law enforcement, research

and analysis. 433.25 (Reserved) 433.26 Neomycin sulfate ointment intended

for hypersensitivity testing.

Subpart D-Records and Reports

433.30 Records retention.

AUTHORITY: 21 U.S.C. 352, 355, 357.

SOURCE: 39 FR 18939, May 30, 1974, unless otherwise noted.

in an applicable antibiotic application or abbreviated antibiotic application.

(3) The bulk antibiotic drug used in preparing the antibiotic drug product meets the standards of identity, strength, quality, and purity specified in the applicable regulation (monograph) in this chapter except where other standards have been approved in an applicable antibiotic application or abbreviated antibiotic application.

(4) The antibiotic drug product meets the standards of identity, strength, quality, and purity specified in the applicable regulation (monograph) in this chapter except where other standards have been approved in an applicable antibiotic application or abbreviated antibiotic application.

(c) The over-the-counter antibiotic drug product for human use is required to meet the general conditions established in $330.1 of this chapter, and the conditions specified in an applicable over-the-counter drug monograph in this chapter.

(d) In accordance with the provisions of section 507(e) of the act, an antibiotic-containing drug for human use exempt from the requirements for batch certification under paragraph (b) of this section is subject following its approval to section 505 of the act and applicable regulations for new drugs, generally parts 310 through 314 of this chapter. For each antibiotic drug subject to an exemption under paragraph (b) of this section:

(1) An approved antibiotic application is regarded to be an approved application under $314.50 of this chapter.

(2) An approved abbreviated antibiotic application is regarded to be an approved abbreviated application under $314.94 of this chapter.

(e) Nothing in this section prevents a manufacturer from applying for batch certification of an antibiotic drug for human use subject to an exemption under this section as provided in section 507(c) of this act.

(f) All exemptions from batch certification requirements for antibiotic drugs for human use under this section

Subpart A-General Provisions

$ 433.1 Exemption of antibiotic drugs

for human use from batch certifi

cation requirements. (a) Antibiotic drugs for human use are exempt from the batch certification requirements of part 431 of this chapter if the conditions of paragraph (b) of this section are met; or, in the case of over-the-counter antibiotic drugs subject to an over-the-counter drug monograph in this chapter, if the conditions of paragraph (c) of this section are met.

(b) The conditions are as follows:

(1) The antibiotic drug is approved for marketing under an appropriate antibiotic application or abbreviated antibiotic application or is the subject of review under the Drug Efficacy Study Implementation Program.

(2) The antibiotic drug is packaged and labeled for dispensing in accordance with the applicable regulation (monograph) in this chapter except where other labeling has been approved

are subject to the conditions of effectiveness under $ 433.2.

(Approved by the Office of Management and Budget under control number 0910-0001)

(d) Any person who contests the revocation or suspension or denial of reinstatement of an exemption from batch certification requirements for an antibiotic drug for human use shall have an opportunity for a regulatory hearing before the Food and Drug Administration under part 16 of this chapter.

(51 FR 25524, July 15, 1986; 51 FR 30478, Aug. 27, 1986, as amended at 57 FR 18001, Apr. 28, 1992]

[47 FR 39159, Sept. 7, 1982, as amended at 51 FR 25524, July 15, 1986)

8 433.2 Conditions on the effectiveness

of exemptions of antibiotic drugs for human use from batch certifi

cation requirements. (a) If at any time an exemption from batch certification requirements for an antibiotic drug for human use has been granted, the Commissioner finds on the basis of new information before the agency with respect to such exempted drug, evaluated together with the evidence available to the agency when such exemption was granted, that certification of each batch is necessary to ensure its safety and efficacy of use, the Commissioner shall act immediately to revoke all exemptions from batch certification requirements granted for such drug.

(b) If the Commissioner finds that the person granted an exemption from batch certification requirements for an antibiotic drug for human use has failed either to comply with the requirements of section 505 of the act and the regulations promulgated thereunder or to meet the general conditions established in $330.1 of this chapter and the conditions specified in an applicable over-the-counter drug monograph in this chapter; or if the Commissioner finds that the requirements of $433.1 have not been met; or if the Commissioner finds that the petition for exemption from batch certification contains any false statements of fact, the Commissioner may revoke the exemption from batch certification requirements immediately and require batch certification of the drug until such person shows adequate cause why the exemption from batch certification requirements should be reinstated.

(c) If the Commissioner repeals or suspends an exemption from batch certification requirements for an antibiotic drug for human use, a notice to that effect and the reasons therefor will be published in the FEDERAL REGISTER.

$ 433.3 Assay requirements for anti

biotic drugs exempted from certifi

cation. (a) Certain antibiotic drugs are exempted by regulations in this chapter from the certification requirements of sections 507 and 512 of the act if such drugs comply with standards prescribed by such regulations and on condition that the label of each package bears an expiration date which is determined from the date during which the batch was last assayed and released by the manufacturer.

(b) It is the position of the Food and Drug Administration that if each batch of such exempted drugs is not tested by the manufacturer or his agent to determine whether it complies with the standards of identity, strength, quality, and purity prescribed for it, the batch is not exempt from certification and it may be deemed to be misbranded under section 502(1) of the act or be adulterated under section 501(a)(5) of the act when in interstate commerce.

Subpart B-Exemptions for which

an Application or Notice is Required

8433.12 Exemption for labeling.

(a) Except as provided by paragraphs (c) and (d) of this section, a shipment or other delivery of a certifiable antibiotic drug which is to be labeled at an establishment located elsewhere than at the place of manufacture shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from the requirement of section 502(1) of the act or the certification requirements of section 512(n) of the act if the labeling of each shipping container bears the batch mark of the drug, the number of units per package

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