r/title-21-FOOD-AND-DRUGS wiki — defined terms

“mobile retail vendor” applies throughout its chapter

The term “mobile retail vendor” means a person or entity that makes sales at retail from a stand that is intended to be temporary, or is capable of being moved from one location to another, whether the stand is located within or on the premises of a fixed facility (such as a kiosk at a shopping center or an airport) or whether the stand is located on unimproved real estate (such as a lot or field leased for retail purposes). (48) The term “at retail”, with respect to the sale or purchase of a scheduled listed chemical product, means a sale or purchase for personal use, respectively. (49);

“narcotic drug” applies throughout its subchapter

The term “narcotic drug” means any of the following whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis: (A) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium. (B) Poppy straw and concentrate of poppy straw.

“online pharmacy” applies in that section

The term “online pharmacy”— (A) means a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet; and (B) does not include— (i) manufacturers or distributors registered under subsection (a), (b), (e), or (f) of section 823 of this title who do not dispense controlled substances to an unregistered individual or entity; (ii) nonpharmacy practitioners who are registered under section 823(g) of this title and whose activities are authorized by that registration; (iii) any hospital or other medical …

“opiate” applies throughout its subchapter

The term “opiate” or “opioid” means any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.;

“opioid” applies throughout its subchapter

The term “opiate” or “opioid” means any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.;

“opium poppy” applies throughout its subchapter

The term “opium poppy” means the plant of the species Papaver somniferum L., except the seed thereof.;

“poppy straw” applies throughout its subchapter

The term “poppy straw” means all parts, except the seeds, of the opium poppy, after mowing.;

“practice of telemedicine” applies in that section

The term “practice of telemedicine” means, for purposes of this subchapter, the practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1395m(m) of title 42 , which practice— (A) is being conducted— (i) while the patient is being treated by, and physically located in, a hospital or clinic registered under section 823(g) of this title ; and (ii) by a practitioner— (I) acting in the usual course of professional practice; (II) acting in …

“practitioner” applies throughout its subchapter

The term “practitioner” means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.;

“production” applies throughout its subchapter

The term “production” includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance.;

“refilling prescriptions for controlled substances in schedule III, IV, or V” applies throughout its subchapter

The term “refilling prescriptions for controlled substances in schedule III, IV, or V”— (A) means the dispensing of a controlled substance in schedule III, IV, or V in accordance with refill instructions issued by a practitioner as part of a valid prescription that meets the requirements of subsections (b) and (c) of section 829 of this title , as appropriate; and (B) does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed.;

“regular customer” applies throughout its subchapter

The term “regular customer” means, with respect to a regulated person, a customer with whom the regulated person has an established business relationship that is reported to the Attorney General.;

“regular importer” applies throughout its subchapter

The term “regular importer” means, with respect to a listed chemical, a person that has an established record as an importer of that listed chemical that is reported to the Attorney General.;

“regulated person” applies throughout its subchapter

The term “regulated person” means a person who manufactures, distributes, imports, or exports a listed chemical, a tableting machine, or an encapsulating machine or who acts as a broker or trader for an international transaction involving a listed chemical, a tableting machine, or an encapsulating machine.;

“regulated seller” applies throughout its chapter

The term “regulated seller” means a retail distributor (including a pharmacy or a mobile retail vendor), except that such term does not include an employee or agent of such distributor.;

“regulated transaction” applies throughout its subchapter

The term “regulated transaction” means— (A) a distribution, receipt, sale, importation, or exportation of, or an international transaction involving shipment of, a listed chemical, or if the Attorney General establishes a threshold amount for a specific listed chemical, a threshold amount, including a cumulative threshold amount for multiple transactions (as determined by the Attorney General, in consultation with the chemical industry and taking into consideration the quantities normally used for lawful purposes), of a listed chemical, except that such term does not include— (i) a domestic lawful distribution in the usual course of business between agents or employees of a single regulated …

“retail distributor” applies throughout its chapter

The term “retail distributor” means a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to ephedrine, pseudoephedrine, or phenylpropanolamine products are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales. (B) For purposes of this paragraph, entities are defined by reference to the Standard Industrial Classification (SIC) code, as follows: (i) A grocery store is an entity within SIC code 5411. (ii) A general merchandise store is an entity within SIC codes 5300 through 5399 and 5499.

“scheduled listed chemical product” applies throughout its chapter

The term “scheduled listed chemical product” means, subject to subparagraph (B), a product that— (i) contains ephedrine, pseudoephedrine, or phenylpropanolamine; and (ii) may be marketed or distributed lawfully in the United States under the Federal, Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] as a nonprescription drug. Each reference in clause (i) to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.

“serious bodily injury” applies throughout its subchapter

The term “serious bodily injury” means bodily injury which involves— (A) a substantial risk of death; (B) protracted and obvious disfigurement; or (C) protracted loss or impairment of the function of a bodily member, organ, or mental faculty.;

“serious drug felony” applies in that section

The term “serious drug felony” means an offense described in section 924(e)(2) of title 18 for which— (A) the offender served a term of imprisonment of more than 12 months; and (B) the offender’s release from any term of imprisonment was within 15 years of the commencement of the instant offense.;

“serious violent felony” applies in that section

The term “serious violent felony” means— (A) an offense described in section 3559(c)(2) of title 18 for which the offender served a term of imprisonment of more than 12 months; and (B) any offense that would be a felony violation of section 113 of title 18 , if the offense were committed in the special maritime and territorial jurisdiction of the United States, for which the offender served a term of imprisonment of more than 12 months.;

“Single Convention on Narcotic Drugs” applies throughout its subchapter

the term “Single Convention on Narcotic Drugs” means the Single Convention on Narcotic Drugs signed at New York, New York, on March 30, 1961 . (32) (A) Except as provided in subparagraph (C),

“State” applies throughout its subchapter

The term “State” means a State of the United States, the District of Columbia, and any commonwealth, territory, or possession of the United States.;

“trader” applies throughout its chapter

The terms “broker” and “trader” mean a person that assists in arranging an international transaction in a listed chemical by— (A) negotiating contracts; (B) serving as an agent or intermediary; or (C) bringing together a buyer and seller, a buyer and transporter, or a seller and transporter.;

“ultimate user” applies throughout its subchapter

The term “ultimate user” means a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household. (28) The term “United States”, when used in a geographic sense, means all places and waters, continental or insular, subject to the jurisdiction of the United States.;

“cannabimimetic agents” applies in that section

The term “cannabimimetic agents” means any substance that is a cannabinoid receptor type 1 (CB1 receptor) agonist as demonstrated by binding studies and functional assays within any of the following structural classes: (i) 2-(3-hydroxycyclohexyl)phenol with substitution at the 5-position of the phenolic ring by alkyl or alkenyl, whether or not substituted on the cyclohexyl ring to any extent. (ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole by substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent, whether or not substituted on the naphthoyl or naphthyl ring to any extent.

“fentanyl-related substance” applies in that section

the term “fentanyl-related substance” means any substance that is structurally related to fentanyl by 1 or more of the following modifications: (A) By replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle. (B) By substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or nitro groups. (C) By substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups. (D) By replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle.

“employee of a qualified hospice program” applies in that section

The term “employee of a qualified hospice program” means a physician, physician assistant, nurse, or other person who— (I) is employed by, or pursuant to arrangements made by, a qualified hospice program; (II) (aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and (bb) is acting within the scope of such employment in accordance with applicable State law; and (III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion.;

“hospice care” applies in that section

The terms “hospice care” and “hospice program” have the meanings given to those terms in section 1395x(dd) of title 42 .;

“hospice program” applies in that section

The terms “hospice care” and “hospice program” have the meanings given to those terms in section 1395x(dd) of title 42 .;

“qualified hospice program” applies in that section

The term “qualified hospice program” means a hospice program that— (I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person’s death; (II) at the time when the controlled substances are first ordered— (aa) provides a copy of the written policies and procedures to the patient or patient representative and family; (bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and (cc) documents in the patient’s clinical record that …

“covered entity” applies in that section

the term “covered entity” means— (1) a State, local, or tribal law enforcement agency; (2) a manufacturer, distributor, or reverse distributor of prescription medications; (3) a retail pharmacy; (4) a registered narcotic treatment program; (5) a hospital or clinic with an onsite pharmacy; (6) an eligible long-term care facility; or (7) any other entity authorized by the Drug Enforcement Administration to dispose of prescription medications.

“authorizing medical professional” applies in that section

The term “authorizing medical professional” means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant)— (i) who is registered under this chapter; (ii) who is acting within the scope of the registration; and (iii) whose scope of practice under a State license or certification includes the ability to provide verbal orders.;

“designated location” applies in that section

The term “designated location” means a location designated by an emergency medical services agency under paragraph (5).;

“emergency medical services” applies in that section

The term “emergency medical services” means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility.;

“emergency medical services agency” applies in that section

The term “emergency medical services agency” means an organization providing emergency medical services, including such an organization that— (i) is governmental (including fire-based and hospital-based agencies), nongovernmental (including hospital-based agencies), private, or volunteer-based; (ii) provides emergency medical services by ground, air, or otherwise; and (iii) is authorized by the State in which the organization is providing such services to provide emergency medical care, including the administering of controlled substances, to members of the general public on an emergency basis.;

“emergency medical services professional” applies in that section

The term “emergency medical services professional” means a health care professional (including a nurse, paramedic, or emergency medical technician) licensed or certified by the State in which the professional practices and credentialed by a medical director of the respective emergency medical services agency to provide emergency medical services within the scope of the professional’s State license or certification.;

“emergency medical services vehicle” applies in that section

The term “emergency medical services vehicle” means an ambulance, fire apparatus, supervisor truck, or other vehicle used by an emergency medical services agency for the purpose of providing or facilitating emergency medical care and transport or transporting controlled substances to and from the registered and designated locations.;

“first applicable registration” applies in that section

The term “first applicable registration” means the first registration or renewal of registration by a qualified practitioner under this section that occurs on or after the date that is 180 days after December 29, 2022 . (B) Qualified practitioner In this subsection,

“hospital-based” applies in that section

The term “hospital-based” means, with respect to an agency, owned or operated by a hospital.;

“medical director” applies in that section

The term “medical director” means a physician who is registered under subsection (g) and provides medical oversight for an emergency medical services agency.;

“medical oversight” applies in that section

The term “medical oversight” means supervision of the provision of medical care by an emergency medical services agency.;

“qualified practitioner” applies in that section

the term “qualified practitioner” means a practitioner who— (i) is licensed under State law to prescribe controlled substances; and (ii) is not solely a veterinarian. (n) Special provisions for practitioners conducting certain research with schedule I controlled substances (1) In general Notwithstanding subsection (g), a practitioner may conduct research described in paragraph (2) of this subsection with 1 or more schedule I substances in accordance with subparagraph (A) or (B) of paragraph (3) of this subsection.

“registered emergency medical services agency” applies in that section

The term “registered emergency medical services agency” means— (i) an emergency medical services agency that is registered pursuant to this subsection; or (ii) a hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection (g).;

“registered location” applies in that section

The term “registered location” means a location that appears on the certificate of registration issued to an emergency medical services agency under this subsection or subsection (g), which shall be where the agency receives controlled substances from distributors.;

“specific State authority” applies in that section

The term “specific State authority” means a governmental agency or other such authority, including a regional oversight and coordinating body, that, pursuant to State law or regulation, develops clinical protocols regarding the delivery of emergency medical services in the geographic jurisdiction of such agency or authority within the State that may be adopted by medical directors.;

“standing order” applies in that section

The term “standing order” means a written medical protocol in which a medical director determines in advance the medical criteria that must be met before administering controlled substances to individuals in need of emergency medical services.;

“verbal order” applies in that section

The term “verbal order” means an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional. (l) “Factors as may be relevant to and consistent with the public health and safety” defined In this section, the phrase “factors as may be relevant to and consistent with the public health and safety” means factors that are relevant to and consistent with the findings contained in section 801 of this title .

“covering practitioner” applies in that section

The term “covering practitioner” means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who— (i) has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and (ii) is temporarily unavailable to conduct the evaluation of the patient.

“in-person medical evaluation” applies in that section

The term “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals. (ii) Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.;

“valid prescription” applies in that section

The term “valid prescription” means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by— (i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or (ii) a covering practitioner. (B);

“drug product” applies in that section

The term “drug product” means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act 1 [ 21 U.S.C. 301 et seq.] for distribution in the United States.;

“valid prescription” applies in that section

The term “valid prescription” means a prescription which is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner’s professional practice.

“authorized purchaser” applies in that section

The term “authorized purchaser” means any of the following persons, provided such person has acquired the controlled substance in accordance with this chapter: (i) A person with a valid prescription that is issued for a legitimate medical purpose in the usual course of professional practice that is based upon a qualifying medical relationship by a practitioner registered by the Attorney General.

“boobytrap” applies in that section

the term “boobytrap” means any concealed or camouflaged device designed to cause bodily injury when triggered by any action of any unsuspecting person making contact with the device. Such term includes guns, ammunition, or explosive devices attached to trip wires or other triggering mechanisms, sharpened stakes, and lines or wires with hooks attached.

“date rape drug” applies in that section

The term “date rape drug” means— (i) gamma hydroxybutyric acid (GHB) or any controlled substance analogue of GHB, including gamma butyrolactone (GBL) or 1,4–butanediol; (ii) ketamine; (iii) flunitrazepam; or (iv) any substance which the Attorney General designates, pursuant to the rulemaking procedures prescribed by section 553 of title 5 , to be used in committing rape or sexual assault. The Attorney General is authorized to remove any substance from the list of date rape drugs pursuant to the same rulemaking authority.;

“without that individual’s knowledge” applies in that section

the term “without that individual’s knowledge” means that the individual is unaware that a substance with the ability to alter that individual’s ability to appraise conduct or to decline participation in or communicate unwillingness to participate in conduct is administered to the individual.

“laboratory supply” applies in that section

the term “laboratory supply” means a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General, which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals.

“advertisement” applies in that section

the term “advertisement” includes, in addition to its ordinary meaning, such advertisements as those for a catalog of Schedule 1 I controlled substances and any similar written advertisement that has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule 1 I controlled substance. The term “advertisement” does not include material which merely advocates the use of a similar material, which advocates a position or practice, and does not attempt to propose or facilitate an actual transaction in a Schedule 1 I controlled substance.

“communication facility” applies in that section

the term “communication facility” means any and all public and private instrumentalities used or useful in the transmission of writing, signs, signals, pictures, or sounds of all kinds and includes mail, telephone, wire, radio, and all other means of communication. (c) Advertisement (1) It shall be unlawful for any person to place in any newspaper, magazine, handbill, or other publications, any written advertisement knowing that it has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule 1 I controlled substance. As used in this section

“drug, narcotic, or chemical offense” applies in that section

the term “drug, narcotic, or chemical offense” means any offense which proscribes the possession, distribution, manufacture, cultivation, sale, transfer, or the attempt or conspiracy to possess, distribute, manufacture, cultivate, sell or transfer any substance the possession of which is prohibited under this subchapter.

“law enforcement officer” applies in that section

the term “law enforcement officer” means a public servant authorized by law or by a Government agency or Congress to conduct or engage in the prevention, investigation, prosecution or adjudication of an offense, and includes those engaged in corrections, probation, or parole functions. (g) 2 to (p) Repealed. Pub. L. 109–177, title II, § 221(2) , Mar. 9, 2006 , 120 Stat. 231 (q) Repealed. Pub. L. 109–177, title II , §§ 221(4), 222(c), Mar. 9, 2006 , 120 Stat. 231 , 232 (r) Repealed. Pub. L. 109–177, title II, § 221(3) , Mar. 9, 2006 , 120 Stat.

“enterprise” applies in that section

the term “enterprise” includes any individual, partnership, corporation, association, or other legal entity, and any union or group of individuals associated in fact although not a legal entity. (d) Construction The provisions of this section shall be liberally construed to effectuate its remedial purposes.

“playground” applies in that section

The term “playground” means any outdoor facility (including any parking lot appurtenant thereto) intended for recreation, open to the public, and with any portion thereof containing three or more separate apparatus intended for the recreation of children including, but not limited to, sliding boards, swingsets, and teeterboards.;

“swimming pool” applies in that section

The term “swimming pool” includes any parking lot appurtenant thereto.

“video arcade facility” applies in that section

The term “video arcade facility” means any facility, legally accessible to persons under 18 years of age, intended primarily for the use of pinball and video machines for amusement containing a minimum of ten pinball and/or video machines.;

“youth center” applies in that section

The term “youth center” means any recreational facility and/or gymnasium (including any parking lot appurtenant thereto), intended primarily for use by persons under 18 years of age, which regularly provides athletic, civic, or cultural activities.;

“Federal benefit” applies in that section

the term “Federal benefit”— (A) means the issuance of any grant, contract, loan, professional license, or commercial license provided by an agency of the United States or by appropriated funds of the United States; and (B) does not include any retirement, welfare, Social Security, health, disability, veterans benefit, public housing, or other similar benefit, or any other benefit for which payments or services are required for eligibility; and;

“veterans benefit” applies in that section

the term “veterans benefit” means all benefits provided to veterans, their families, or survivors by virtue of the service of a veteran in the Armed Forces of the United States. (e) Inapplicability of this section to Government witnesses The penalties provided by this section shall not apply to any individual who cooperates or testifies with the Government in the prosecution of a Federal or State offense or who is in a Government witness protection program.

“State” applies in that section

the term “State” has the meaning given it— (1) in section 419(5) of the Social Security Act [ 42 U.S.C. 619(5) ], when referring to assistance provided under a State program funded under part A of title IV of the Social Security Act [ 42 U.S.C. 601 et seq.], and (2) in section 3 of the Food and Nutrition Act of 2008 ( 7 U.S.C. 2012 ), when referring to the supplemental nutrition assistance program (as defined in that section) or any State program carried out under that Act [ 7 U.S.C. 2011 et seq.]. (f) Rule of interpretation Nothing in this section shall be construed to deny the following Federal benefits: (1) Emergency medical services under title XIX of the Social Security Act [ 42 U.S.C.

“drug paraphernalia” applies in that section

The term “drug paraphernalia” means any equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance, possession of which is unlawful under this subchapter.

“eligible entity” applies in that section

The term “eligible entity” means— (A) a producer of agricultural commodities; (B) a cooperative association, a majority of the members of which produce or process agricultural commodities; or (C) a person in the trade or business of— (i) selling an agricultural product (including an agricultural chemical) at retail, predominantly to farmers and ranchers; or (ii) aerial and ground application of an agricultural chemical. (2) Nurse tank The term “nurse tank” shall be considered to be a cargo tank (within the meaning of section 173.315(m) of title 49, Code of Federal Regulations, as in effect as of the date of the enactment of this Act).

“controlled premises” applies in that section

the term “controlled premises” means— (1) places where original or other records or documents required under this subchapter are kept or required to be kept, and (2) places, including factories, warehouses, and other establishments, and conveyances, where persons registered under section 823 of this title (or exempt from registration under section 822(d) of this title or by regulation of the Attorney General) or regulated persons may lawfully hold, manufacture, distribute, dispense, administer, or otherwise dispose of controlled substances or listed chemicals or where records relating to those activities are maintained.

“probable cause” applies in that section

the term “probable cause” means a valid public interest in the effective enforcement of this subchapter or regulations thereunder sufficient to justify administrative inspections of the area, premises, building, or conveyance, or contents thereof, in the circumstances specified in the application for the warrant. (2) A warrant shall issue only upon an affidavit of an officer or employee having knowledge of the facts alleged, sworn to before the judge or magistrate judge and establishing the grounds for issuing the warrant.

“controlled substance and chemical diversion control activities” applies in that section

The term “controlled substance and chemical diversion control activities” means those activities related to the registration and control of the manufacture, distribution, dispensing, importation, and exportation of controlled substances and listed chemicals.

“diversion control program” applies in that section

The term “diversion control program” means the controlled substance and chemical diversion control activities of the Drug Enforcement Administration. (B) Controlled substance and chemical diversion control activities

“controlled substance” applies in that section

The term “controlled substance” has the same meaning given such term in section 802(6) of this title .;

“Secretary” applies in that section

The term “Secretary” means the Secretary of Agriculture.;

“State” applies in that section

The term “State” means each of the fifty States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands of the United States, American Samoa, the Commonwealth of the Northern Mariana Islands, or the Trust Territory of the Pacific Islands.

“customs territory of the United States” applies throughout its subchapter

The term “customs territory of the United States” has the meaning assigned to such term by general note 2 of the Harmonized Tariff Schedule of the United States. (b) Each term defined in section 802 of this title shall have the same meaning for purposes of this subchapter as such term has for purposes of subchapter I.

“import” applies throughout its subchapter

The term “import” means, with respect to any article, any bringing in or introduction of such article into any area (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States).;

“anything of pecuniary value” applies in that section

the term “anything of pecuniary value” has the meaning given the term in section 1958(b)(1) of title 18 .

“exporter” applies in that section

The terms “importer” and “exporter” mean a regulated person who imports or exports a listed chemical, respectively. (B) The term “transfer”, with respect to a listed chemical, includes the sale of the chemical.;

“importer” applies in that section

The terms “importer” and “exporter” mean a regulated person who imports or exports a listed chemical, respectively. (B) The term “transfer”, with respect to a listed chemical, includes the sale of the chemical.;

“transferee” applies in that section

The term “transferee” means a person to whom an importer or exporter transfers a listed chemical. (e) Broker or trader for international transaction in listed chemical A person located in the United States who is a broker or trader for an international transaction in a listed chemical that is a regulated transaction solely because of that person’s involvement as a broker or trader shall, with respect to that transaction, be subject to all of the notification, reporting, recordkeeping, and other requirements placed upon exporters of listed chemicals by this subchapter and subchapter I.

“check” applies throughout its chapter

The term “check” means an egg that has a broken shell or crack in the shell but has its shell membranes intact and contents not leaking.;

“clean and sound shell egg” applies throughout its chapter

The term “clean and sound shell egg” means any egg whose shell is free of adhering dirt or foreign material and is not cracked or broken.;

“commerce” applies throughout its chapter

The term “commerce” means interstate, foreign, or intrastate commerce.;

“container” applies throughout its chapter

The term “container” or “package” includes any box, can, tin, plastic, or other receptacle, wrapper, or cover.;

“dirty egg” applies throughout its chapter

The term “dirty egg” means an egg that has a shell that is unbroken and has adhering dirt or foreign material.;

“egg” applies throughout its chapter

The term “egg” means the shell egg of the domesticated chicken, turkey, duck, goose, or guinea.;

“egg handler” applies throughout its chapter

The term “egg handler” means any person who engages in any business in commerce which involves buying or selling any eggs (as a poultry producer or otherwise), or processing any egg products, or otherwise using any eggs in the preparation of human food.;

“egg product” applies throughout its chapter

The term “egg product” means any dried, frozen, or liquid eggs, with or without added ingredients, excepting products which contain eggs only in a relatively small proportion or historically have not been, in the judgment of the Secretary, considered by consumers as products of the egg food industry, and which may be exempted by the Secretary under such conditions as he may prescribe to assure that the egg ingredients are not adulterated and such products are not represented as egg products.;

“immediate container” applies throughout its chapter

The term “immediate container” means any consumer package; or any other container in which egg products, not consumer packaged, are packed.;

“incubator reject” applies throughout its chapter

The term “incubator reject” means an egg that has been subjected to incubation and has been removed from incubation during the hatching operations as infertile or otherwise unhatchable.;

“inedible” applies throughout its chapter

The term “inedible” means eggs of the following descriptions: black rots, yellow rots, white rots, mixed rots (addled eggs), sour eggs, eggs with green whites, eggs with stuck yolks, moldy eggs, musty eggs, eggs showing blood rings, and eggs containing embryo chicks (at or beyond the blood ring stage).;

“inspection” applies throughout its chapter

The term “inspection” means the application of such inspection methods and techniques as are deemed necessary by the responsible Secretary to carry out the provisions of this chapter.;

“inspector” applies throughout its chapter

The term “inspector” means: (1) any employee or official of the United States Government authorized to inspect eggs or egg products under the authority of this chapter; or (2) any employee or official of the government of any State or local jurisdiction authorized by the Secretary to inspect eggs or egg products under the authority of this chapter, under an agreement entered into between the Secretary and the appropriate State or other agency. (l) The term “misbranded” shall apply to egg products which are not labeled and packaged in accordance with the requirements prescribed by regulations of the Secretary under section 1036 of this title .;

“leaker” applies throughout its chapter

The term “leaker” means an egg that has a crack or break in the shell and shell membranes to the extent that the egg contents are exposed or are exuding or free to exude through the shell.;

“loss” applies throughout its chapter

The term “loss” means an egg that is unfit for human food because it is smashed or broken so that its contents are leaking; or overheated, frozen, or contaminated; or an incubator reject; or because it contains a bloody white, large meat spots, a large quantity of blood, or other foreign material.;

“official certificate” applies throughout its chapter

The term “official certificate” means any certificate prescribed by regulations of the Secretary for issuance by an inspector or other person performing official functions under this chapter.;

“official device” applies throughout its chapter

The term “official device” means any device prescribed or authorized by the Secretary for use in applying any official mark.;

“official inspection legend” applies throughout its chapter

The term “official inspection legend” means any symbol prescribed by regulations of the Secretary showing that egg products were inspected in accordance with this chapter.;

“official mark” applies throughout its chapter

The term “official mark” means the official inspection legend or any other symbol prescribed by regulations of the Secretary to identify the status of any article under this chapter.;

“official plant” applies throughout its chapter

The term “official plant” means any plant, as determined by the Secretary, at which inspection of the processing of egg products is maintained by the Department of Agriculture under the authority of this chapter.;

“official standards” applies throughout its chapter

The term “official standards” means the standards of quality, grades, and weight classes for eggs, in effect upon the effective date of this chapter, or as thereafter amended, under the Agricultural Marketing Act of 1946 ( 60 Stat. 1087 , as amended; 7 U.S.C. 1621 et seq.).;

“package” applies throughout its chapter

The term “container” or “package” includes any box, can, tin, plastic, or other receptacle, wrapper, or cover.;

“pasteurize” applies throughout its chapter

The term “pasteurize” means the subjecting of each particle of egg products to heat or other treatments to destroy harmful viable micro-organisms by such processes as may be prescribed by regulations of the Secretary.;

“person” applies throughout its chapter

The term “person” means any individual, partnership, corporation, association, or other business unit. (u) The terms “pesticide chemical,” “food additive,” “color additive,” and “raw agricultural commodity” shall have the same meaning for purposes of this chapter as under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.].;

“plant” applies throughout its chapter

The term “plant” means any place of business where egg products are processed.;

“processing” applies throughout its chapter

The term “processing” means manufacturing egg products, including breaking eggs or filtering, mixing, blending, pasteurizing, stabilizing, cooling, freezing, drying, or packaging egg products.;

“restricted egg” applies throughout its chapter

The term “restricted egg” means any check, dirty egg, incubator reject, inedible, leaker, or loss. (h) The term “Fair Packaging and Labeling Act” [ 15 U.S.C. 1451 et seq.] means the Act so entitled, approved November 3, 1966 ( 80 Stat. 1296 ), and Acts amendatory thereof or supplementary thereto. (i) The term “Federal Food, Drug, and Cosmetic Act” [ 21 U.S.C. 301 et seq.] means the Act so entitled, approved June 25, 1938 ( 52 Stat. 1040 ), and Acts amendatory thereof or supplementary thereto.;

“Secretary” applies throughout its chapter

The term “Secretary” means the Secretary of Agriculture or his delegate.;

“shipping container” applies throughout its chapter

The term “shipping container” means any container used in packaging a product packed in an immediate container.;

“State” applies throughout its chapter

The term “State” means any State of the United States, the Commonwealth of Puerto Rico, the Virgin Islands of the United States, and the District of Columbia.;

“United States” applies throughout its chapter

The term “United States” means the States.

“Administrator” applies throughout its subchapter

The term “Administrator” means the Administrator appointed by the Director under section 1531(c) of this title . (2) Advisory Commission

“Advisory Commission” applies throughout its subchapter

The term “Advisory Commission” means the Advisory Commission established under section 1541 1 of this title. (3) Community The term “community” shall have the meaning provided that term by the Administrator, in consultation with the Advisory Commission. (4) Director

“Director” applies throughout its subchapter

The term “Director” means the Director of the Office of National Drug Control Policy. (5) Eligible coalition

“eligible coalition” applies throughout its subchapter

The term “eligible coalition” means a coalition that meets the applicable criteria under section 1532(a) of this title . (6) Grant recipient

“grant recipient” applies throughout its subchapter

The term “grant recipient” means the recipient of a grant award under section 1532 of this title . (7) Nonprofit organization

“nonprofit organization” applies throughout its subchapter

The term “nonprofit organization” means an organization described under section 501(c)(3) of title 26 that is exempt from taxation under section 501(a) of title 26 . (8) Program

“Program” applies throughout its subchapter

The term “Program” means the program established under section 1531(a) of this title . (9) Substance use and misuse

“substance use and misuse” applies throughout its subchapter

The term “substance use and misuse” means— (A) the illegal use or misuse of drugs, including substances for which a listing is effect 2 under any of schedules I through V under section 812 of this title ; (B) the misuse of inhalants or over-the-counter drugs; or (C) the use of alcohol, tobacco, or other related product as such use is prohibited by State or local law. (10) Youth The term “youth” shall have the meaning provided that term by the Administrator, in consultation with the Advisory Commission.

“Administrator” applies in that section

The term “Administrator” means the Administrator of the Substance Abuse and Mental Health Services Administration. (2) Director

“Director” applies in that section

The term “Director” means the Director of the Office of National Drug Control Policy. (3) Drug-Free Communities Act of 1997

“Drug-Free Communities Act of 1997” applies in that section

The term “Drug-Free Communities Act of 1997” means chapter 2 of the National Narcotics Leadership Act of 1988 ( 21 U.S.C. 1521 et seq.). (4) Eligible entity

“eligible entity” applies in that section

The term “eligible entity” means an organization that— (A) on or before the date of submitting an application for a grant under this section, receives or has received a grant under the Drug-Free Communities Act of 1997; and (B) has documented, using local data, rates of abuse of opioids or methamphetamines at levels that are— (i) significantly higher than the national average as determined by the Secretary (including appropriate consideration of the results of the Monitoring the Future Survey published by the National Institute on Drug Abuse and the National Survey on Drug Use and Health published by the Substance Abuse and Mental Health Services Administration); or (ii) higher than the …

“emerging drug abuse issue” applies in that section

The term “emerging drug abuse issue” means a substance use disorder within an area involving— (A) a sudden increase in demand for particular drug abuse treatment services relative to previous demand; and (B) a lack of resources in the area to address the emerging problem. (6) Local drug crisis

“local drug crisis” applies in that section

The term “local drug crisis” means, with respect to the area served by an eligible entity— (A) a sudden increase in the abuse of opioids or methamphetamines, as documented by local data; (B) the abuse of prescription medications, specifically opioids or methamphetamines, that is significantly higher than the national average, over a sustained period of time, as documented by local data; or (C) a sudden increase in opioid-related deaths, as documented by local data. (7) Opioid

“opioid” applies in that section

The term “opioid” means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability. (b) Program authorized The Director, in coordination with the Administrator, may make grants to eligible entities to implement comprehensive community-wide strategies that address local drug crises and emerging drug abuse issues within the area served by the eligible entity.

“biomaterials supplier” applies throughout its chapter

The term “biomaterials supplier” means an entity that directly or indirectly supplies a component part or raw material for use in the manufacture of an implant. (B) Persons included Such term includes any person who— (i) has submitted master files to the Secretary for purposes of premarket approval of a medical device; or (ii) licenses a biomaterials supplier to produce component parts or raw materials. (2) Claimant (A) In general

“claimant” applies throughout its chapter

The term “claimant” means any person who brings a civil action, or on whose behalf a civil action is brought, arising from harm allegedly caused directly or indirectly by an implant, including a person other than the individual into whose body, or in contact with whose blood or tissue, the implant is placed, who claims to have suffered harm as a result of the implant. (B) Action brought on behalf of an estate With respect to an action brought on behalf of or through the estate of a deceased individual into whose body, or in contact with whose blood or tissue the implant was placed, such term includes the decedent that is the subject of the action.

“component part” applies throughout its chapter

The term “component part” means a manufactured piece of an implant. (B) Certain components Such term includes a manufactured piece of an implant that— (i) has significant non-implant applications; and (ii) alone, has no implant value or purpose, but when combined with other component parts and materials, constitutes an implant. (4) Harm (A) In general

“harm” applies throughout its chapter

The term “harm” means— (i) any injury to or damage suffered by an individual; (ii) any illness, disease, or death of that individual resulting from that injury or damage; and (iii) any loss to that individual or any other individual resulting from that injury or damage. (B) Exclusion The term does not include any commercial loss or loss of or damage to an implant. (5) Implant

“implant” applies throughout its chapter

The term “implant” means— (A) a medical device that is intended by the manufacturer of the device— (i) to be placed into a surgically or naturally formed or existing cavity of the body for a period of at least 30 days; or (ii) to remain in contact with bodily fluids or internal human tissue through a surgically produced opening for a period of less than 30 days; and (B) suture materials used in implant procedures. (6) Manufacturer

“manufacturer” applies throughout its chapter

The term “manufacturer” means any person who, with respect to an implant— (A) is engaged in the manufacture, preparation, propagation, compounding, or processing (as defined in section 360(a)(1) of this title ) of the implant; and (B) is required— (i) to register with the Secretary pursuant to section 360 of this title and the regulations issued under such section; and (ii) to include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section. (7) Medical device

“medical device” applies throughout its chapter

The term “medical device” means a device, as defined in section 321(h) of this title , and includes any device component of any combination product as that term is used in section 353(g) of this title . (8) Raw material

“raw material” applies throughout its chapter

The term “raw material” means a substance or product that— (A) has a generic use; and (B) may be used in an application other than an implant. (9) Secretary

“Secretary” applies throughout its chapter

The term “Secretary” means the Secretary of Health and Human Services. (10) Seller (A) In general

“seller” applies throughout its chapter

The term “seller” means a person who, in the course of a business conducted for that purpose, sells, distributes, leases, packages, labels, or otherwise places an implant in the stream of commerce. (B) Exclusions The term does not include— (i) a seller or lessor of real property; (ii) a provider of professional health care services in any case in which— (I) the sale or use of the implant is incidental to such services; and (II) the essence of the professional health care services provided is the furnishing of judgment, skill, or services; or (iii) any person who acts in only a financial capacity with respect to the sale of an implant.

“agency” applies throughout its chapter

The term “agency” has the meaning given the term “executive agency” in section 102 of title 31 . (2) Appropriate congressional committees (A) In general

“appropriate congressional committees” applies throughout its chapter

The term “appropriate congressional committees” means— (i) the Committee on the Judiciary, the Committee on Appropriations, and the Committee on Health, Education, Labor, and Pensions of the Senate; and (ii) the Committee on Oversight and Government Reform, the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives. (B) Submission to Congress Any submission to Congress shall mean submission to the appropriate congressional committees. (3) Demand reduction

“demand reduction” applies throughout its chapter

The term “demand reduction” means any activity conducted by a National Drug Control Program agency, other than an enforcement activity, that is intended to reduce or prevent the use of drugs or support, expand, or provide treatment and recovery efforts, including— (A) education about the dangers of illicit drug use; (B) services, programs, or strategies to prevent substance use disorder, including evidence-based education campaigns, community-based prevention programs, collection and disposal of unused prescription drugs, and services to at-risk populations to prevent or delay initial use of an illicit drug; (C) substance use disorder treatment; (D) support for long-term recovery from …

“Director” applies in that section

The term “Director” means the Director of National Drug Control Policy. (5) Drug

“drug” applies in that section

The term “drug” has the meaning given the term “controlled substance” in section 802(6) of this title . (6) Drug control

“drug control” applies in that section

The term “drug control” means any activity conducted by a National Drug Control Program agency involving supply reduction or demand reduction. (7) Emerging drug threat

“drug law enforcement” applies in that section

The term “law enforcement” or “drug law enforcement” means all efforts by a Federal, State, local, or Tribal government agency to enforce the drug laws of the United States or any State, including investigation, arrest, prosecution, and incarceration or other punishments or penalties. (10) National Drug Control Program

“emerging drug threat” applies in that section

The term “emerging drug threat” means the occurrence of a new and growing trend in the use of an illicit drug or class of drugs, including rapid expansion in the supply of or demand for such drug. (8) Illicit drug use; illicit drugs; illegal drugs

“illegal drugs” applies in that section

The terms “illicit drug use”, “illicit drugs”, and “illegal drugs” include the illegal or illicit use of prescription drugs. (9) Law enforcement