otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(2) Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.

(3) The recordkeeping requirements in paragraph (f) of this section shall be followed for all incoming and outgoing prescription drugs.

(e) Returned, damaged, and outdated prescription drugs. (1) Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier.

(2) Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.

(3) If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, then the drug shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling, as a result of storage or shipping.

(4) The recordkeeping requirements in paragraph (f) of this section shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.

(f) Recordkeeping. (1) Wholesale drug distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records shall include the following information:

(i) The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;

(ii) The identity and quantity of the drugs received and distributed or disposed of; and

(iii) The dates of receipt and distribution or other disposition of the drugs.

(2) Inventories and records shall be made available for inspection and photocopying by authorized Federal, State, or local law enforcement agency officials for a period of 2 years following disposition of the drugs.

(3) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within 2 working days of a request by an authorized official of a Federal, State, or local law enforcement agency.

(g) Written policies and procedures. Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors shall inIclude in their written policies and procedures the following:

(1) A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The procedure may permit deviation from this requirement, if such deviation is temporary and appropriate.

(2) A procedure to be followed for handling recalls and withdrawals of

prescription drugs. Such procedure shall be adequate to deal with recalls and withdrawals due to:

(i) Any action initiated at the request of the Food and Drug Administration or other Federal, State, or local law enforcement or other government agency, including the State licensing agency;

(ii) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

(iii) Any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.

(3) A procedure to ensure that wholesale drug distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, State, or national emergency.

(4) A procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for 2 years after disposition of the outdated drugs.

(h) Responsible persons. Wholesale drug distributors shall establish and maintain lists of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

(i) Compliance with Federal, State, and local law. Wholesale drug distributors shall operate in compliance with applicable Federal, State, and local laws and regulations.

(1) Wholesale drug distributors shall permit the State licensing authority and authorized Federal, State, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law.

(2) Wholesale drug distributors that deal in controlled substances shall register with the appropriate State controlled substance authority and with the Drug Enforcement Administration (DEA), and shall comply with all applicable State, local, and DEA regulations.

(j) Salvaging and reprocessing. Wholesale drug distributors shall be subject to the provisions of any applicable Federal, State, or local laws or regulations that relate to prescription drug product salvaging or reprocessing, including parts 207, 210, and 211 of this chapter.

(Approved by the Office of Management and Budget under control number 09100251)

(a) The following definitions apply to this part:

(1) Act means the Federal Food, Drug, and Cosmetic Act approved June 25, 1938 (52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)), except as otherwise provided.

(2) Advertising and labeling include the promotional material described in § 202.1(1) (1) and (2) respectively.

(3) Any material change includes but is not limited to any change in the name of the drug, any change in the identity or quantity of the active ingredient(s), any change in the identity or quantity of the inactive ingredient(s) where quantitative listing of all ingredients is required by § 207.31(a)(2), any significant change in the labeling of a prescription drug, and any significant change in the label or package insert of an over-thecounter drug. Changes that are not significant include changes in arrangement or printing or changes of an editorial nature.

(4) Bulk drug substance means any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.

(5) Commercial distribution means any distribution of a human drug except for investigational use under part 312 of this chapter, and any distribution of an animal drug or an animal feed bearing or containing an animal drug for noninvestigational

uses, but the term does not include internal or interplant transfer of a bulk drug substance between registered domestic establishments within the same parent, subsidiary, and/or affiliate company.

(6) Drug product salvaging means the act of segregating drug products that may have been subjected to improper storage conditions, such as extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation, for the purpose of returning some or all of the products to the marketplace.

(7) Establishment means a place of business under one management at one general physical location. The term includes, among others, independent laboratories that engage in control activities for a registered drug establishment (e.g., consulting laboratories), manufacturers of medicated feeds and of vitamin products that are drugs in accordance with section 201(g) of the act, human blood donor centers, and animal facilities used for the production or control testing of licensed biologicals, and establishments engaged in drug product salvaging.

(8) Manufacturing or processing means the manufacture, preparation, propagation, compounding, or processing of a drug or drugs as used in section 510 of the act and is the making by chemical, physical, biological, or other procedures of any articles that meet the definition of drugs in section 201(g) of the act. The term includes manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process. The term also includes repackaging or otherwise changing the container, wrapper, or labeling of any drug package to further the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate con

sumer.

(9) Representative sampling of advertisements means typical advertising material (excluding labeling as determined in § 202.1(1) (1) and (2)) that gives a balanced picture of the promotional claims used for the drug, e.g., if more than one medical journal advertisement is used but the promotional

content is essentially identical, only one need be submitted.

(10) Representative sampling of any other labeling means typical labeling material (excluding labels and package inserts) that gives a balanced picture of the promotional claims used for the drug, e.g., if more than one brochure is used but the promotional content is essentially identical, only one need be submitted.

(b) The definitions and interpretations of terms in sections 201, 502(e), and 510 of the act apply to the use of terms in this part.

[45 FR 38043, June 6, 1980, as amended at 55 FR 11576, Mar. 29, 1990]

§ 207.7 Establishment registration and product listing for human blood and blood products and for medical devices. (a) Owners and operators of human blood and blood product establishments shall register and list their products with the Division of Product Certification, Office of Biological Product Review (HFB-240), Center for Biologics Evaluation and Research, 8800 Rockville Pike, Bethesda, MD 20892, on Form FDA-2830 (Blood Establishment Registration and Product Listing), in acordance with part 607. Such owners and operators who also manufature or process other drug products at the same establishment shall, in addition, register and list all such other drug products with the Drug Listing Branch in accordance with this part.

(b) [Reserved]

(c) Owners and operators of establishments engaged in manufacture or processing of medical devices shall register and list their products with the Center for Devices and Radiological Health, FDA, on Form FDA-2891 (Initial Registration of Device Establishments), FDA-2891a (Registration of Device Establishment), and FDA-2892 (Medical Device Listing), in accordance with part 807.

(d) Owners and operators of establishments engaged in the manufacture or processing at the same establishment of both drug products and medical devices shall (1) register with the Drug Listing Branch (HFD-334), Center for Drug Evaluation and Research, FDA, and list their drug prod

ucts in accordance with this part, and (2) register with the Center for Devices and Radiological Health and list their medical devices in accordance with part 807.

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

Subpart B-Exemptions

§ 207.10 Exemptions for domestic estab

lishments.

The following classes of persons are exempt from registration and drug listing in accordance with this part under section 510(g) (1), (2), and (3) of the act, or because FDA has found, under section 510(g)(4), that their registration is not necessary for the protection of the public health.

(a) Pharmacies that operate under applicable local laws regulating dispensing of prescription drugs and that do not manufacture or process drugs for sale other than in the regular course of the practice of the profession of pharmacy, including dispensing and selling drugs at retail. The supplying of prescription drugs by these pharmacies to a practitioner licensed to administer these drugs for his or her use in the course of professional practice or to other pharmacies to meet temporary inventory shortages are not acts that require pharmacies to register.

(b) Hospitals, clinics, and public health agencies that maintain establishments in conformance with any applicable local laws regulating the practices of pharmacy or medicine and that regularly engage in dispensing prescription drugs, other than human blood or blood products, upon prescription of practitioners licensed by law to administer these drugs to patients under their professional care.

(c) Practitioners who are licensed by law to prescribe or administer drugs and who manufacture or process drugs solely for use in their professional practice.

(d) Persons who manufacture or process drugs not for sale but solely for use in research, teaching, or chemical analysis.

(e) Manufacturers of harmless inactive ingredients that are excipients, colorings, flavorings, emulsifiers, lubricants, preservatives, or solvents that become components of drugs, and who otherwise would not be required to register under this part.

(f) Persons who manufacture Type B or Type C medicated feed using Category I, Type A medicated articles; Category I, Type B medicated feeds; and/ or Category II, Type B medicated feeds, as defined in § 558.3 of this chapter, as drug sources.

(g) Any manufacturer of a virus, serum, toxin, or analogous product intended for treatment of domestic animals who holds an unsuspended and unrevoked license issued by the Secretary of Agriculture under the animal virus-serum-toxin law of March 4, 1913 (37 Stat. 832 (21 U.S.C. 151 et seq.)), provided that this exemption from registration applies only to the manufacture or processing of that animal virus, serum, toxin, or analogous product.

(h) Carriers, in their receipt, carriage, holding, or delivery of drugs in the usual course of business as carriers.

[45 FR 38043, June 6, 1980, as amended at 51 FR 7389, Mar. 3, 1986]

Subpart C-Procedures for Domestic Drug Establishments

§ 207.20 Who must register and submit a drug list.

(a) Owners or operators of all drug establishments, not exempt under section 510(g) of the act or subpart D of this part 207, that engage in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs are required to register and to submit a list of every drug in commercial distribution (except that listing information may be submitted by the parent, subsidiary, and/or affiliate company for all establishments when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments). Such owners or operators are required to register and to submit a list of every drug in commercial distribution (except that list

ing information may be submitted by the parent, subsidiary, and/or affiliate company for all establishments when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments), whether or not the output of such establishment or any particular drug so listed enters interstate commerce, except that drug listing is not required at this time for the manufacturing, preparation, propagation, compounding, or processing of an animal feed (including a Type B and Type C medicated feed) bearing or containing an animal drug, nor is drug listing required for establishments engaged in drug product salvaging. No owner or operator may register an establishment, if any part of the establishment is registered by any other owner or operator.

(b) Owners or operators of establishments not otherwise required to register under section 510 of the act that distribute under their own label or trade name a drug manufactured or processed by a registered establishment may elect to submit listing information directly to FDA and to obtain a Labeler Code. A distributor who submits drug listing information shall include the registration number of the drug establishment that manufactured, prepared, propagated, compounded, or processed each drug listed. All distributors who submit

drug listing information to FDA assume full responsibility for compliance with all of the requirements of this part. Each such distributor at the time of submitting or updating drug listing information as required under § 207.30 shall certify to the registered establishment that the submission has been made by providing a signed copy of Form FDA-2656 (Registration of Drug Establishment) to the registered establishment that manufactures or processes the drug. Each such distributor shall submit the original of Form FDA-2656 showing this certification to FDA, and shall accompany the certification with a list showing the National Drug Code number that the distributor has assigned to each drug product. If a distributor does not elect to submit drug listing information directly to FDA and to obtain a Labeler