US LAWS, STATUTES & CODES ON-LINE

(b) Owners and operators of all registered establishments shall update their drug listing information every June and December.

[45 FR 38043, June 6, 1980, as amended at 55 FR 11576, Mar. 29, 1990; 64 FR 400, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 64 FR 63203, Nov. 19, 1999; 66 FR 59157, Nov. 27, 2001]

(a) An establishment shall register the first time on Form FDA–2656 (Registration of Drug Establishment), obtainable on request from the Records Repository Team (HFD–143), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or from FDA district offices. An establishment whose drug registration for that year was validated under §207.35 shall make subsequent annual registration on Form FDA–2656 as described in §207.21(a) by mailing the completed form to the above address within 30 days after receipt from FDA.

(b) The first list of drugs and later June and December updatings shall be on Form FDA–2657 (Drug Product Listing), obtainable upon request as described in paragraph (a) of this section. An establishment may submit, in lieu of Form FDA–2657, tapes for computer inputs containing the information specified in Form FDA–2657 if formats proposed for this use were reviewed and approved by the Records Repository Team (HFD–143), Center for Drug Evaluation and Research, FDA.

[45 FR 38043, June 6, 1980, as amended at 50 FR 8995, Mar. 6, 1985; 55 FR 11576, Mar. 29, 1990; 69 FR 48775, Aug. 11, 2004]

(a) Form FDA–2656 (Registration of Drug Establishment) provides for furnishing or confirming information required by the act. This information includes, for each establishment, the name and full address of the drug establishment; all trade names used by the establishment; the kind of ownership or operation (that is, individually owned, partnership or corporation); and the name of the owner or operator of the establishment. The term name of the owner or operator includes in the case of a partnership the name of each partner, and in the case of a corporation the name and title of each corporate officer and director and the name of the State of incorporation.

(b) Form FDA–2657 (Drug Product Listing) provides that information required by the act be furnished as follows:

(1) A list of drugs, including bulk drug substances and Type A articles for use in the manufacture of animal feeds as well as finished dosage forms, by established name and by proprietary name, that are being manufactured or processed for commercial distribution and that have not been included in any list previously submitted to FDA on Form FDA–2657 or in conjunction with the FDA voluntary inventory on Form FDA–2422 (Survey Report of Marketed Drugs), or Form FDA–2250 (National Drug Code Directory Input).

(2) For each drug listed that the registrant regards as subject to section 505 or 512 of the act, the new drug application number, abbreviated new drug application number, new animal drug application number, or abbreviated new animal drug application number and a copy of all current labeling, except that only one representative container or carton label need be submitted where differences exist only in the quantity of contents statement.

(3) For each drug listed that the registrant regards as subject to section 351 of the Public Health Service Act, the license number of the manufacturer.

(4) For each human prescription drug listed that the registrant regards as not subject to section 505 of the act or 351 of the Public Health Service Act, and that is not manufactured by a registered blood bank, a copy of all current labeling (except that only one representative container or carton label need be submitted where differences exist only in the quantity of contents statement) and a representative sampling of advertisements.

(5) For each human over-the-counter drug listed, or each animal drug listed, that the registrant regards as not subject to section 505 or 512 of the act or 351 of the Public Health Service Act, a copy of the label (except that only one representative container or carton label need be submitted where differences exist only in the quantity of contents statement), the package insert, and a representative sampling of any other labeling.

(6) For each prescription or over-the-counter drug so listed that the registrant regards as not subject to section 505 or 512 of the act or 351 of the Public Health Service Act, and that is not manufactured by a registered blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is expressed as a percentage in the offical compendium or the ingredient is a nonantibiotic ingredient in a Type A medicated article for use in the manufacture of animal feeds, the quantity of an ingredient shall be expressed in terms of the amount, not the percent, of that ingredient in each dosage unit or, if the drug is not in unit dosage form, the amount of the ingredient in a specific unit of weight or measure of the drug. For a drug formulation that is a Type A medicated article subject to §207.35(b)(2)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of active drug ingredient.

(7) For each drug listed, the registration number of every drug establishment within the parent company at which it is manufactured or processed.

(8) For each drug listed, the National Drug Code (NDC) number. If FDA has not assigned an NDC Labeler Code, the registrant shall include a Product Code and Package Code and FDA will assign a Labeler Code as described in §207.35(b)(2)(i).

(c) For each drug product listed that is subject to the imprinting requirements of part 206 of this chapter, including products that are exempted under §206.7(b), drug companies must submit a document that provides the name of the product, its active ingredient(s), dosage strength, National Drug Code number, the name of its manufacturer or distributor, its size, shape, color, and code imprint (if any), and any other characteristic that identifies the product as unique.

[45 FR 38043, June 6, 1980, as amended at 52 FR 2682, Jan. 26, 1987; 55 FR 11577, Mar. 29, 1990; 58 FR 47959, Sept. 13, 1993; 63 FR 26698, May 13, 1998; 64 FR 400, Jan. 5, 1999; 66 FR 59157, Nov. 27, 2001]

Changes in individual ownership, corporate or partnership structure location or drug-handling activity, shall be submitted by Form FDA–2656 (Registration of Drug Establishment) as amendment to registration within 5 days of such changes. A change in a registered establishment's firm name within 6 months of the registration of the establishment is required to be supported by a signed statement of the establishment's owner or operator that the change is not made for the purpose of changing the name of the manufacturer of a drug product under §201.1 of this chapter. Changes in the names of officers and directors of the corporations do not require such amendment but must be shown at time of annual registration.

[45 FR 25777, Apr. 15, 1980, as amended at 55 FR 11577, Mar. 29, 1990]

(a) After submitting the initial drug listing information, every person who is required to list drugs under §207.20 shall submit on Form FDA–2657 (Drug Product Listing) during each subsequent June and December, or at the discretion of the registrant when the change occurs, the following information:

(1) A list of each drug introduced by the registrant for commerical distribution which has not been included in any list previously submitted. The registrant shall provide all of the information required by §207.25(b) for each such drug.

(2) A list of each drug formerly listed in accordance with §207.25(b) for which commercial distribution has been discontinued, including for each drug so listed the National Drug Code (NDC) number, the identity by established name and by proprietary name, and date of discontinuance. It is requested but not required that the reason for discontinuance of distribution be included with this information.

(3) A list of each drug for which a notice of discontinuance was submitted under paragraph (a)(2) of this section and for which commercial distribution has been resumed, including for each drug so listed the NDC number, the identity by established name and by proprietary name, the date of resumption, and any other information required by §207.25(b) not previously submitted.

(4) Any material change in any information previously submitted.

(b) When no changes have occurred since the previously submitted list, no report is required.

(a) In addition to the information routinely required by §§207.25 and 207.30, FDA may require submission of the following information by letter or by Federal Register notice:

(1) For a particular prescription drug so listed that the registrant regards as not subject to section 505 of the act, upon request by FDA for good cause, a copy of all advertisements.

(2) For a particular drug product so listed that the registrant regards as not subject to section 505 or 512 of the act, upon a finding by FDA that it is necessary to carry out the purposes of the act, a quantitative listing of all ingredients.

(3) For a particular drug product, upon request by FDA, a brief statement of the basis for the registrant's belief that the drug product is not subject to section 505 or 512 of the act.

(4) For each registrant, upon a finding by FDA that it is necessary to carry out the purposes of the act, a list of each listed drug product containing a particular ingredient.

(b) It is requested but not required that a qualitative listing of the inactive ingredients be submitted for all listed drugs in the format prescribed in Form FDA–2657 (Drug Product Listing).

(c) It is requested but not required that a quantitative listing of the active ingredients be submitted for all drugs listed that are subject to section 505 or 512 of the act or section 351 of the Public Health Service Act.

[45 FR 38043, June 6, 1980, as amended at 63 FR 26698, May 13, 1998; 64 FR 400, Jan. 5, 1999]

(a) FDA will provide to the registrant a validated copy of Form FDA–2656 (Registration of Drug Establishment) as evidence of registration. This validated copy will be sent to the mailing address shown on the form. FDA will assign a permanent registration number to each drug establishment registered in accordance with these regulations.

(b) Using the National Drug Code (NDC) numbering system, FDA assigns a drug listing number to each drug or class of drugs listed as follows:

(1) If a drug is already listed in the National Drug Code System or in the National Health Related Items Code System, the number is the same as that assigned under those codes. FDA adds a lead zero to the first three characters of the code, which identifies the manufacturer or distributor, to expand the “Labeler Code” segment to four characters. The National Drug Code, Product Code, and Package Code configurations used to describe these drugs, or any drugs added to the product line, remain the same, i.e., a four-character Product Code and a two-character Package Code. A manufacturer or distributor may either retain alphanumeric characters that are already used in the Product Code and Package Code segments of the National Drug Code or convert these alphanumeric characters to all numeric digits. The manufacturer or distributor shall inform FDA of a decision to convert the alphanumeric characters to all numeric digits.

(2) If a registered establishment or distributor has not previously participated in the National Drug Code System or in the National Health Related Items Code System, FDA uses the National Drug Code numbering system in assigning a number, as follows (only numerals are used):

(i) The first 5 numeric characters of the 10-character code identify the manufacturer or distributor and are known as the Labeler Code. FDA will expand the Labeler Code from five to six numeric characters when the available five-character code combinations are exhausted. FDA will assign Labeler Code numbers and provide them to the registrant along with the validated copy of Form FDA–2656. Any registered firm that does not have an assigned Labeler Code will be assigned one when registration and listing information are submitted.

(ii) The last 5 numeric characters of the 10-character code identify the drug and the trade package size and type. The segment that identifies the drug formulation is known as the Product Code and the segment that identifies the trade package size and type is known as the Package Code. The manufacturer or distributor will assign the Product Code and the Package Code before drug listing and include these codes in Form FDA–2657 (Drug Product Listing). The manufacturer or distributor may use either of two methods in assigning the Product and Package Codes: a 3–2 Product-Package Code configuration (e.g., 542–12) or a 4–1 Product-Package Code configuration (e.g., 5421–2). A manufacturer or distributor with a given Labeler Code shall use only one such Product-Package Code configuration and shall use this same configuration in assigning the Product-Package Codes for all drugs included in the drug listing. The manufacturer or distributor shall report to FDA the Product-Package Code configuration used in assigning these codes.

(iii) If the drug formulation is a Type A medicated article intended for use in the manufacture of an animal feed, FDA assigns a separate Product Code only for each variation of level of active drug ingredient.

(3) FDA requests but does not require that the NDC number appear on all drug labels and in other drug labeling, including the label of any prescription drug container furnished to a consumer. If the NDC number is shown on a drug label, it shall be placed as follows:

(i) The NDC number shall appear prominently in the top third of the principal display panel of the label on the immediate container and of any outside container or wrapper. Instead of appearing in the top third of the label, the NDC number may appear as part of and contiguous to any bar-code symbol for any drug product if two conditions are met. First, the symbol appears prominently on the immediate container and on any outside container or wrapper and in a conspicuous location; this condition is not satisfied by the appearance of the symbol only on the natural bottom of a container or wrapper. Second, the bar-code symbol is compatible with the NDC, i.e., the symbol provides a format capable of encoding the numeric characters of an NDC Number. The term principal display panel, as used in this paragraph, means that part of a label most likely to be displayed, presented, shown, or examined under customary conditions of display to the consumer (for over-the-counter drug products) or to the dispenser (for prescription drug products).

(ii) The NDC number shall be preceded by the prefix “NDC” or “N” when it is used on a label or in labeling. The prefix used for a drug product shall be used consistently on the label of the immediate container, outside container, or wrapper, if any, and on other labeling for that drug product.

(iii) The Product-Package Code configuration shall be indicated and the segments of the number shall be separated by a dash, e.g., NDC 15643–542–12 or N 15643–542–12.

(iv) All 10 characters shall appear and the leading zeros in any segment of the NDC number shall be shown, except that leading zeros may be omitted from any segment of the NDC number when the NDC number is used for product identification by direct imprinting on dosage forms or in the case of containers too small or otherwise unable to accommodate a label with sufficent space to bear both required and optional labeling information.

(v) The placing of the assigned NDC number on a label or in other labeling does not require the submission of a supplemental new drug application, supplemental new animal drug application.

(4)(i) If any change occurs in those product characteristics that clearly distinguish one drug product version from another, the registrant shall assign a new NDC number to the new product version and submit that information to FDA. Such a change includes, but is not limited to, a change in active ingredient(s); strength or concentration of active ingredient(s); dosage form; route of administration, if it also includes a change in product formulation; product name; and a change in marketing status from prescription to over-the-counter or over-the-counter to prescription. If, by notice in the Federal Register, FDA requires a change in drug product characteristics and determines the change will require assignment of a new product code to the reformulated product, FDA will announce its determination in the Federal Register publication that requires the change, setting forth its reasoning and justification for its determination. If a change only in the trade package is involved, the registrant may revise the trade package code without the assignment of a new product code segment, but shall inform FDA of the new code for the trade package and the characteristics of the new trade package.

(ii) When a registrant has discontinued a drug product, its product code may be reassigned to another drug product 5 years after the expiration date of the discontinued product, or, if there is no expiration date, 5 years after the last shipment of the discontinued product into commercial distribution. Reuse of product codes may occur, under the specified conditions, regardless of the NDC, Product Code, and Package Code configuration used.

(c) Although registration and drug listing are required to engage in the drug activities described in § 207.20, validation of registration and the assignment of a drug listing number do not, in themselves, establish that the holder of the registration is legally qualified to deal in such drugs.

[45 FR 38043, June 6, 1980, as amended at 48 FR 54007, Nov. 30, 1983; 52 FR 2682, Jan. 26, 1987; 55 FR 11577, Mar. 29, 1990; 64 FR 400, Jan. 5, 1999]

(a) A copy of the Form FDA–2656 (Registration of Drug Establishment) filed by the registrant will be available for inspection in accordance with section 510(f) of the act, at the Records Repository Team (HFD–143), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. In addition, copies of these forms for establishments located within a particular geographic area are available for inspection at FDA district offices responsible for that geographical area. Copies of forms submitted by foreign drug establishments are available for inspection at the Division of Manufacturing and Product Quality, Foreign Inspection Team (HFD–325), Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Upon request and receipt of a stamped, self-addressed envelope, the Records Repository Team, the Foreign Inspection Team, or the appropriate FDA district office will verify registration numbers or provide the location of a registered establishment. The mailing address for the Foreign Inspection Team is: Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research (HFD–325), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

(1) The following types of information submitted under the drug listing requirements will be available for public disclosure when compiled:

(i) A list of all drug products.

(ii) A list of all drug products arranged by labeled indications or pharmacological category.

(iii) A list of all drug products arranged by manufacturer.

(iv) A list of a drug product's active ingredients.

(v) A list of drug products newly marketed or for which marketing is resumed.

(vi) A list of drug products discontinued.

(vii) Labeling.

(viii) Advertising.

(ix) Information that has become a matter of public knowledge.

(x) A list of drug products containing a particular active ingredient.

(xi) A list of all code imprints.

(2) The following types of information submitted in accordance with the drug listing requirements will not be available for public disclosure (except that any of the information will be available for public disclosure if it has become a matter of public knowledge or if FDA finds that confidentiality would be inconsistent with protection of the public health):

(i) Any information submitted as the basis upon which it has been determined that a particular drug product is not subject to section 505 or 512 of the act.

(ii) A list of a drug product's inactive ingredients.

(iii) A list of drugs containing a particular inactive ingredient.

(b) Requests for information about registrations and drug listings of an establishment should be directed to the Information Management Team (HFD–095), Office of Information Technology, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 or, with respect to the information described in paragraph (a) of this section, to the FDA district office responsible for the geographic area in which the establishment is located.

[45 FR 38043, June 6, 1980, as amended at 50 FR 8996, Mar. 6, 1985; 55 FR 11577, Mar. 29, 1990; 58 FR 47959, Sept. 13, 1993; 63 FR 26698, May 13, 1998; 64 FR 400, Jan. 5, 1999; 66 FR 59157, Nov. 27, 2001; 69 FR 48775, Aug. 11, 2004]

Registration of a drug establishment or drug wholesaler, or assignment of a registration number, or assignment of a NDC number does not in any way denote approval of the firm or its products. Any representation that creates an impression of official approval because of registration or possession of registration number or NDC number is misleading and constitutes misbranding.

(a) Foreign drug establishments whose drugs are imported or offered for import into the United States shall comply with the establishment registration and drug listing requirements in subpart C of this part, unless exempt under subpart B of this part or unless the drugs enter a foreign trade zone and are re-exported from that foreign trade zone without having entered U. S. commerce.

(b) No drug may be imported or offered for import into the United States unless it is listed as required in subpart C of this part and manufactured, prepared, propagated, compounded, or processed at a registered foreign drug establishment; however, this restriction does not apply to a drug imported or offered for import under the investigational use provisions in part 312 of this chapter, or the investigational new animal drug use provisions in part 511 of this chapter, or to a component of a drug imported under section 801(d)(3) of the act. Foreign drug establishments shall submit all listing information, including labels and labeling, and registration information in the English language.

(c) Each foreign drug establishment required to register under paragraph (a) of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with subpart C of this part. Each foreign drug establishment shall designate only one United States agent.

(1) The United States agent shall reside or maintain a place of business in the United States.

(2) Upon request from FDA, the United States agent shall assist FDA in communications with the foreign drug establishment, respond to questions concerning the foreign drug establishment's products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign drug establishment. If the agency is unable to contact the foreign drug establishment directly or expeditiously, FDA may provide information or documents to the United States agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign drug establishment.

(3) The foreign drug establishment or the United States agent shall report changes in the United States agent's name, address, or phone number to FDA within 10-business days of the change.

[66 FR 59157, Nov. 27, 2001]

ChanRobles Legal Resources:

• Jurisprudence, Laws, Statutes & Codes
• Philippine Laws, Statutes & Codes
• Philippine Supreme Court Decisions
• Significant Legal Resources
• WorldWide Legal Recources
• US Federal Laws, Statutes & Codes
• US Supreme Court Decisions
• The Business Page
• ChanRobles Virtual Law Library
  

ChanRobles On-Line Bar Review

ChanRobles MCLE On-line