- abbreviated drug application
means an application submitted under section 355(j) of this title for the approval of a drug that relies on the approved application of another drug with the same active ingredient to establish safety and efficacy, and—
- Abraham Accords country
means a country identified by the Department of State as having signed the Abraham Accords Declaration.
- accreditation body
means an authority that performs accreditation of third-party auditors.
- accredited third-party auditor
means a third-party auditor accredited by an accreditation body to conduct audits of eligible entities to certify that such eligible entities meet the applicable requirements of this section.
- active pharmaceutical ingredient
means—
- additive
means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical.
- adequate expertise
means that the membership of the classification panel includes—
- adequate substantiation of safety
means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
- adjustment factor
means a factor applicable to a fiscal year that is the Consumer Price Index for all urban consumers (all items;
- Administrator
means the Administrator of the United States Environmental Protection Agency.
- advanced and continuous pharmaceutical manufacturing
refers to a method of pharmaceutical manufacturing, or a combination of pharmaceutical manufacturing methods—
- adverse drug experience
means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including—
- adverse event
means any health-related event associated with the use of a cosmetic product that is adverse.
- advisory committee
means an advisory committee under chapter 10 of title 5 that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.
- advisory review
means reviewing and providing advisory comments on DTC advertisements regarding compliance of a proposed advertisement with the requirements of this chapter prior to its initial public dissemination.
- advisory review fee
has the meaning indicated for such term in subsection (a)(1)(D).
- affiliate
means a business entity that has a relationship with a second business entity if, directly or indirectly—
- agency center
means a center or alternative organizational component of the Food and Drug Administration.
- anabolic steroid
has the meaning given such term in section 802(41) of this title;
- analogue of an anabolic steroid
means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.
- animal drug application
means—
- animal drug establishment
means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form.
- animal drug product
means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the National Drug Code, and for which an animal drug application or a supplemental animal drug application has been approved.
- animal drug sponsor
means either an applicant named in an animal drug application that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the Secretary.
- annual distribution number
means the number of such devices reasonably needed to treat, diagnose, or cure a population of 8,000 individuals in the United States.
- antibiotic drug
means any drug (except drugs for use in animals other than humans) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (including a chemically synthesized equivalent of any such substance) or any derivative thereof.
- antimicrobial drug
means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that—
- antimicrobial susceptibility testing device
means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).
- applicable medical imaging device
means a device intended to be used in conjunction with a contrast agent (or class of contrast agents) for an imaging use that is not described in the approved labeling of such contrast agent (or the approved labeling of any contrast agent in the same class as such contrast agent);
- application
means an application submitted under subsection (b)(2) or (j) of this section or section 262(k) of title 42.
- approved drug
means an active ingredient—
- approved use or indication
means the use or indication approved under section 355 of this title or licensed under section 262 of title 42 for a drug designated under section 360bb of this title for a rare disease or condition.
- article
means a paper, poster, abstract, book, book chapter, or other published writing.
- audit agent
means an individual who is an employee or agent of an accredited third-party auditor and, although not individually accredited, is qualified to conduct food safety audits on behalf of an accredited third-party auditor.
- authorized
means—
- authorized distributors of record
means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer’s products.
- authorized generic drug
means a listed drug (as that term is used in subsection (j)) that—
- authorized person
means an officer or employee of the Department of Health and Human Services who has—
- base amount
means the inspection budget determined under subparagraph (B) for fiscal year 2002.
- bioavailability
means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action.
- bioequivalence
means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a new animal drug and becomes available at the site of drug action.
- biological product
has the meaning given such term in section 351 of the Public Health Service Act [42 U.S.C. 262].
- biomedical research consortia
means collaborative groups that may take the form of public-private partnerships and may include government agencies, institutions of higher education (as defined in section 1001(a) of title 20), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals.
- biosimilar biological product
means a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved.
- biosimilar biological product application
means an application for licensure of a biological product under section 262(k) of title 42.
- biosimilar biological product development meeting
means any meeting, other than a biosimilar initial advisory meeting, regarding the content of a development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application.
- biosimilar biological product development program
means the program under this subpart for expediting the process for the review of submissions in connection with biosimilar biological product development.
- biosimilar biological product establishment
means a foreign or domestic place of business—
- brand
means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name, identifiable pattern of colors, or any combination of such attributes.
- bulk vehicle
includes a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.
- carry over submission
means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year.
- characteristics
means the materials, ingredients, design, composition, heating source, or other features of a tobacco product.
- children
means individuals who are under the age of twelve years.
- cigarette tobacco
means any product that consists of loose tobacco that is intended for use by consumers in a cigarette.
- clinical outcome assessment
means—
- color
includes black, white, and intermediate grays.
- color additive
means a material which— except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.
- commerce
has the meaning given that term by section 1332(2) of title 15.
- commercially reasonable, market-based terms
means—
- Commissioner
means the Commissioner of Food and Drugs.
- competitive generic therapy
means a drug—
- compounding
includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.
- consultative audit
means an audit of an eligible entity—
- context of use
means, with respect to a drug development tool, the circumstances under which the drug development tool is to be used in drug development and regulatory review.
- contract manufacturing organization facility
means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.
- contrast agent
means a drug that is approved under section 355 of this title or licensed under section 262 of title 42, is intended for use in conjunction with an applicable medical imaging device, and—
- cosmetic
means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles;
- cosmetic product
means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.
- costs of resources allocated for OTC monograph drug activities
means the expenses in connection with OTC monograph drug activities for—
- counterfeit device
means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.
- counterfeit drug
means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.
- counterfeit tobacco product
means a tobacco product (or the container or labeling of such a product) that, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a tobacco product listed in a registration under section 387e(i)(1) of this title.
- countermeasure
means a qualified countermeasure, a security countermeasure, and a qualified pandemic or epidemic product;
- coupon
means a form which may be redeemed, at no cost or at a reduced cost, for a drug which is prescribed in accordance with subsection (b).
- covered application
means—
- covered drug
means a drug approved under section 355(c) of this title—
- critical control point
means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.
- critical food
means a food that is—
- critical reprocessed single-use device
means a reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use.
- current good manufacturing practice
includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.
- cyber device
means a device that—
- data
refers to information with respect to a drug approved under this section or under section 262 of title 42, including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, and any other data deemed appropriate by the Secretary.
- date of approval
shall mean the later of—
- de novo classification request
means a request made under section 360c(f)(2)(A) of this title with respect to the classification of a device.
- Department
means Department of Health and Human Services.
- designated medical gas
means any of the following:
- designated platform technology
means a platform technology that is designated as a platform technology under subsection (d).
- device
has the meaning given the term in section 321 of this title;
- device user facility
means a hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility which is not a physician’s office.
- different technological characteristics
means, with respect to a device being compared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device.
- different, comparable aspect of the elements to assure safe use
means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 355(j) of this title that uses different methods or operational means than the strategy required under subsection (a) for the applicable listed drug, or other application under section 355(j) of this title with the same such listed drug, but achieves the same level of safety as such strategy.
- direct-to-consumer television advertisement
means an advertisement for a prescription drug product (as defined in section 379g(3) of this title) intended to be displayed on any television channel for less than 3 minutes.
- distribution
means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription executed in accordance with section 353(b)(1) of this title or the dispensing of a product approved under section 360b(b) of this title.
- domestic facility
means a facility located in any of the States or Territories.
- drug
means (A) articles recognized in the official United States Pharmacopoeia,1 official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;
- drug development tool
includes—
- drug product
means a drug subject to regulation under section 355, 360b, or 382 of this title or under section 262 of title 42.
- drug sample
means a unit of a drug, subject to subsection (b), which is not intended to be sold and is intended to promote the sale of the drug.
- efficacy supplement
means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data.
- electronic product
means (A) any manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation;
- electronic product radiation
means—
- eligible countermeasure
means—
- eligible entity
means an entity that meets each of the following:
- eligible investigational drug
means an investigational drug (as such term is used in section 360bbb of this title)—
- eligible patient
means a patient—
- eligible pesticide chemical residue
means a pesticide chemical residue as to which—
- eligible product
means a product that—
- eligible product developer
means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 355 of this title or for licensing pursuant to an application under section 262(k) of title 42;
- emergency medical reasons
includes transfers of a drug between health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of the drug arising from delays in or interruptions of regular distribution schedules.
- emergency use
has the meaning indicated for such term in paragraph (1).
- essentially a copy of an approved drug
means—
- establishment subject to a registration fee
means an establishment that is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.
- exclusive distributor
means the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer’s product to a subsequent repackager, wholesale distributor, or dispenser.
- expiration date
means the date established through appropriate stability testing required by the regulations issued by the Secretary to ensure that the product meets applicable standards of identity, strength, quality, and purity at the time of use.
- facility
includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
- farm
has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).
- final dosage form
means, with respect to a generic new animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing.
- final product stage
means the point in the manufacturing process, before distribution of an infant formula, at which an infant formula is homogenous and is not subject to further degradation.
- final sunscreen order
means an order published by the Secretary in the Federal Register containing information stating that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—
- financial interest
means a financial interest under section 208(a) of title 18.
- finished dosage form
means—
- first applicant
means an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug.
- first approved applicant
means any applicant that has submitted an application that—
- fish
includes freshwater or marine fin fish, crustaceans, and mollusks, including shellfish, amphibians, and other forms of aquatic animal life.
- food
means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
- food additive
means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food;
- food contact substance
means any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.
- food product
means food in any sized package which is manufactured by a single manufacturer or which bears the same brand name, which bears the same statement of identity, and which has similar preparation methods, and
- food to which this section applies
means a food for humans which is a food for special dietary use—
- foreign facility
means a facility that manufacturers,1 processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States.
- full-time equivalent review employees
means the total combined number of full-time equivalent employees in—
- generic drug
means a drug that is approved pursuant to section 355(j) of this title.
- generic drug submission
means an abbreviated new drug application, an amendment to an abbreviated new drug application, or a prior approval supplement to an abbreviated new drug application.
- generic investigational new animal drug meeting request
means a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug.
- generic new animal drug
means a new animal drug that is the subject of an abbreviated application.
- generic new animal drug product
means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved.
- generic new animal drug sponsor
means either an applicant named in an abbreviated application for a generic new animal drug that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive by the Secretary.
- generic version
means a drug approved under section 355(j) of this title whose reference listed drug is a covered drug.
- genetically targeted drug
means a drug that—
- genetically targeted technology
means a technology comprising non-replicating nucleic acid or analogous compounds with a common or similar chemistry that is intended to treat one or more patient subgroups, including subgroups of patients with different mutations of a gene, with the same disease or condition, including a disease or condition due to other variants in the same gene;
- GRASE
means generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of a drug as described in section 321(p) of this title;
- gross annual sales
means the total worldwide gross annual sales, in United States dollars, for an outsourcing facility, including the sales of all the affiliates of the outsourcing facility.
- health care economic information
means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug or device.
- health system
means a collection of hospitals that are owned and operated by the same entity and that share access to databases with drug order information for their patients.
- homogeneous case
means a sealed case containing only product that has a single National Drug Code number belonging to a single lot.
- human data studies
means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies.
- human drug application
means an application for— Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under section 262 of title 42, does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by
- human generic drug activities
means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:
- human growth hormone
means somatrem, somatropin, or an analogue of either of them.
- illegitimate product
means a product for which credible evidence shows that the product—
- illicit trade
means any practice or conduct prohibited by law which relates to production, shipment, receipt, possession, distribution, sale, or purchase of tobacco products including any practice or conduct intended to facilitate such activity.
- importer
means a pharmacist or wholesaler.
- inadequate generic competition
means, with respect to a drug, there is not more than one approved drugs 1 on the list of drugs described in section 355(j)(7)(A) of this title (not including drugs on the discontinued section of such list) that is—
- Indian country
has the meaning given such term in section 1151 of title 18.
- Indian tribe
has the meaning given such term in section 5304(e) of title 25.
- infant formula
means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.
- informal hearing
means a hearing which is not subject to section 554, 556, or 557 of title 5 and which provides for the following:
- institution of higher education
has the meaning given such term in section 1001(a) of title 20.
- interpretive criteria standard
means a compilation of susceptibility test interpretive criteria developed by a standard development organization that meets the criteria set forth in subsection (b)(2)(A)(i).
- interstate commerce
means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
- investigational animal drug submission
means—
- knew
means that a person, with respect to information—
- label
means a display of written, printed, or graphic matter upon the immediate container of any article;
- labeling
means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.
- license holder
means the holder of an application approved under subsection (c) or (j) of section 355 of this title or the holder of a license under subsection (a) or (k) of section 262 of title 42 for a covered product;
- licensed
means—
- little cigar
means a product that—
- major change
has the meaning given to such term in section 106.30(c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986), and guidelines issued thereunder.
- major food allergen
means any of the following:
- major species
means cattle, horses, swine, chickens, turkeys, dogs, and cats, except that the Secretary may add species to this definition by regulation.
- manufacturer
means, with respect to a product—
- manufacturing expenses
means expenses incurred in developing processes and procedures associated with manufacture of the designated new animal drug which occur after the new animal drug is designated under this section and before the date on which an application with respect to such new animal drug is submitted under section 360b or 360ccc of this title.
- market clearance
includes—
- master file holder
means a person who submits data and information to the Secretary with the intent to reference or authorize another person to reference such data or information to support a medical countermeasure submission, as described in subsection (a).
- material threat medical countermeasure application
means an application that—
- medical countermeasure submission
means an investigational new drug application under section 355(i) of this title, a new drug application under section 355(b) of this title, or an abbreviated new drug application under section 355(j) of this title, a biological product license application under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] or a biosimilar biological product license application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)], a new animal drug application under section 360b(b)(1) of this title or abbreviated new animal drug application under section 360b(b)(2) of this title, an application for conditional approval of a new anim
- medical food
means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
- medical gas
means a drug that—
- medical product
includes a drug, a biological product as defined in section 262 of title 42, a device, and any combination of such products.
- menu board
means the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection.
- minor species
means animals other than humans that are not major species.
- minor use
means the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually.
- modified risk tobacco product
means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
- necessary
means the minimum required information that would support a determination of substantial equivalence between a new device and a predicate device.
- new animal drug
means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed,—
- new dietary ingredient
means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.
- new drug
means—
- new human data studies
means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies, the results of which—
- new infant formula
includes— For purposes of this paragraph, the term “major change” has the meaning given to such term in section 106.30(c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986), and guidelines issued thereunder.
- new tobacco product
means—
- new use
means a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section 360j(p) of this title, but that is not described in the approved labeling of the contrast agent;
- nicotine
means the chemical substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or C[10]H[14]N[2], including any salt or complex of nicotine.
- non-human data
means data from testing other than with human subjects which provides information concerning safety or effectiveness.
- nonprescription
means not subject to section 353(b)(1) of this title;
- nonprescription drug
refers to a drug not subject to the requirements of section 353(b)(1) of this title.
- official compendium
means the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.
- operating reserve fee
has the meaning indicated for such term in subsection (a)(2)(A).
- original device
means a new, unused single-use device.
- outsourcing facility
means a facility at one geographic location or address that—
- over-the-counter hearing aid
means a device that—