21 U.S.C. § 830 — Regulation of listed chemicals and certain

Page 832 TITLE 21—FOOD AND DRUGS § 830 1 See References in Text note below. treatment and is to be administered by injection or im- plantation;’’ for ‘‘the controlled substance is to be ad- ministered for the purpose of maintenance or detoxi- fication treatment under section 823(g)(2) and—’’ ‘‘(A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and act- ing within the scope of that section; and ‘‘(B) the controlled substance is to be administered by injection or implantation;’’ was executed by making the substitution for ‘‘the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 823(h)(2) and—’’ and subpars. (A) and (B), to reflect the probable intent of Congress and the intervening amendment by Pub. L. 117–215. See Amendment note below. Pub. L. 117–215 substituted ‘‘823(h)(2)’’ for ‘‘823(g)(2)’’ in introductory provisions. Subsec. (a)(5). Pub. L. 117–328, § 1264, substituted ‘‘45 days’’ for ‘‘14 days’’. § 830. Regulation of listed chemicals and certain machines (a) Record of regulated transactions (1) Each regulated person who engages in a regulated transaction involving a listed chem- ical, a tableting machine, or an encapsulating machine shall keep a record of the transaction for two years after the date of the transaction. (2) A record under this subsection shall be re- trievable and shall include the date of the regu- lated transaction, the identity of each party to the regulated transaction, a statement of the quantity and form of the listed chemical, a de- scription of the tableting machine or encap- sulating machine, and a description of the meth- od of transfer. Such record shall be available for inspection and copying by the Attorney General. (3) It is the duty of each regulated person who engages in a regulated transaction to identify each other party to the transaction. It is the duty of such other party to present proof of identity to the regulated person. The Attorney General shall specify by regulation the types of documents and other evidence that constitute proof of identity for purposes of this paragraph. (b) Reports to Attorney General (1) Each regulated person shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regula- tion— (A) any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this sub- chapter; (B) any proposed regulated transaction with a person whose description or other identi- fying characteristic the Attorney General fur- nishes in advance to the regulated person; (C) any unusual or excessive loss or dis- appearance of a listed chemical under the con- trol of the regulated person; and (D) any regulated transaction in a tableting machine or an encapsulating machine. Each report under subparagraph (A) shall be made at the earliest practicable opportunity after the regulated person becomes aware of the circumstance involved. A regulated person may not complete a transaction with a person whose description or identifying characteristic is fur- nished to the regulated person under subpara- graph (B) unless the transaction is approved by the Attorney General. The Attorney General shall make available to regulated persons guid- ance documents describing transactions and cir- cumstances for which reports are required under subparagraph (A) and subparagraph (C). (2) A regulated person that manufactures a listed chemical shall report annually to the At- torney General, in such form and manner and containing such specific data as the Attorney General shall prescribe by regulation, informa- tion concerning listed chemicals manufactured by the person. The requirement of the preceding sentence shall not apply to the manufacture of a drug product that is exempted under section 802(39)(A)(iv) of this title. (3) MAIL ORDER REPORTING.—(A) As used in this paragraph: (i) The term ‘‘drug product’’ means an active ingredient in dosage form that has been ap- proved 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. (ii) 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 prac- tice. (B) Each regulated person who engages in a transaction with a nonregulated person or who engages in an export transaction which— (i) involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals); and (ii) uses or attempts to use the Postal Serv- ice or any private or commercial carrier; shall, on a monthly basis, submit a report of each such transaction conducted during the pre- vious month to the Attorney General in such form, containing such data, and at such times as the Attorney General shall establish by regula- tion. (C) The data required for such reports shall in- clude— (i) the name of the purchaser; (ii) the quantity and form of the ephedrine, pseudoephedrine, or phenylpropanolamine pur- chased; and (iii) the address to which such ephedrine, pseudoephedrine, or phenylpropanolamine was sent. (D) Except as provided in subparagraph (E), the following distributions to a nonregulated person, and the following export transactions, shall not be subject to the reporting require- ment in subparagraph (B): (i) Distributions of sample packages of drug products when such packages contain not more than two solid dosage units or the equiv- alent of two dosage units in liquid form, not to exceed 10 milliliters of liquid per package, and not more than one package is distributed to an Page 833 TITLE 21—FOOD AND DRUGS § 830 individual or residential address in any 30-day period. (ii) Distributions of drug products by retail distributors that may not include face-to-face transactions to the extent that such distribu- tions are consistent with the activities au- thorized for a retail distributor as specified in section 802(49) of this title, except that this clause does not apply to sales of scheduled listed chemical products at retail. (iii) Distributions of drug products to a resi- dent of a long term care facility (as that term is defined in regulations prescribed by the At- torney General) or distributions of drug prod- ucts to a long term care facility for dispensing to or for use by a resident of that facility. (iv) Distributions of drug products pursuant to a valid prescription. (v) Exports which have been reported to the Attorney General pursuant to section 954 or 971 of this title or which are subject to a waiv- er granted under section 971(f)(2) of this title. (vi) Any quantity, method, or type of dis- tribution or any quantity, method, or type of distribution of a specific listed chemical (in- cluding specific formulations or drug prod- ucts) or of a group of listed chemicals (includ- ing specific formulations or drug products) which the Attorney General has excluded by regulation from such reporting requirement on the basis that such reporting is not nec- essary for the enforcement of this subchapter or subchapter II. (E) The Attorney General may revoke any or all of the exemptions listed in subparagraph (D) for an individual regulated person if he finds that drug products distributed by the regulated person are being used in violation of this sub- chapter or subchapter II. The regulated person shall be notified of the revocation, which will be effective upon receipt by the person of such no- tice, as provided in section 971(c)(1) of this title, and shall have the right to an expedited hearing as provided in section 971(c)(2) of this title. (c) Confidentiality of information obtained by At- torney General; non-disclosure; exceptions (1) Except as provided in paragraph (2), any in- formation obtained by the Attorney General under this section which is exempt from disclo- sure under section 552(a) of title 5, by reason of section 552(b)(4) of such title, is confidential and may not be disclosed to any person. (2) Information referred to in paragraph (1) may be disclosed only— (A) to an officer or employee of the United States engaged in carrying out this sub- chapter, subchapter II, or the customs laws; (B) when relevant in any investigation or proceeding for the enforcement of this sub- chapter, subchapter II, or the customs laws; (C) when necessary to comply with an obli- gation of the United States under a treaty or other international agreement; or (D) to a State or local official or employee in conjunction with the enforcement of con- trolled substances laws or chemical control laws. (3) The Attorney General shall— (A) take such action as may be necessary to prevent unauthorized disclosure of informa- tion by any person to whom such information is disclosed under paragraph (2); and (B) issue guidelines that limit, to the max- imum extent feasible, the disclosure of propri- etary business information, including the names or identities of United States exporters of listed chemicals, to any person to whom such information is disclosed under paragraph (2). (4) Any person who is aggrieved by a disclosure of information in violation of this section may bring a civil action against the violator for ap- propriate relief. (5) Notwithstanding paragraph (4), a civil ac- tion may not be brought under such paragraph against investigative or law enforcement per- sonnel of the Drug Enforcement Administration. (d) Scheduled listed chemicals; restrictions on sales quantity; requirements regarding non- liquid forms With respect to ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product— (1) the quantity of such base sold at retail in such a product by a regulated seller, or a dis- tributor required to submit reports by sub- section (b)(3) may not, for any purchaser, ex- ceed a daily amount of 3.6 grams, without re- gard to the number of transactions; and (2) such a seller or distributor may not sell such a product in nonliquid form (including gel caps) at retail unless the product is pack- aged in blister packs, each blister containing not more than 2 dosage units, or where the use of blister packs is technically infeasible, the product is packaged in unit dose packets or pouches. (e) Scheduled listed chemicals; behind-the- counter access; logbook requirement; train- ing of sales personnel; privacy protections (1) Requirements regarding retail transactions (A) In general Each regulated seller shall ensure that, subject to subparagraph (F), sales by such seller of a scheduled listed chemical product at retail are made in accordance with the following: (i) In offering the product for sale, the seller places the product such that cus- tomers do not have direct access to the product before the sale is made (in this paragraph referred to as ‘‘behind-the- counter’’ placement). For purposes of this paragraph, a behind-the-counter place- ment of a product includes circumstances in which the product is stored in a locked cabinet that is located in an area of the fa- cility involved to which customers do have direct access. (ii) The seller delivers the product di- rectly into the custody of the purchaser. (iii) The seller maintains, in accordance with criteria issued by the Attorney Gen- eral, a written or electronic list of such sales that identifies the products by name, the quantity sold, the names and addresses of purchasers, and the dates and times of the sales (which list is referred to in this subsection as the ‘‘logbook’’), except that Page 834 TITLE 21—FOOD AND DRUGS § 830 such requirement does not apply to any purchase by an individual of a single sales package if that package contains not more than 60 milligrams of pseudoephedrine. (iv) In the case of a sale to which the re- quirement of clause (iii) applies, the seller does not sell such a product unless the sale is made in accordance with the following: (I) The prospective purchaser— (aa) presents an identification card that provides a photograph and is issued by a State or the Federal Gov- ernment, or a document that, with re- spect to identification, is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of title 8, Code of Federal Regulations (as in effect on or after March 9, 2006); and (bb) signs the written logbook and enters in the logbook his or her name, address, and the date and time of the sale, or for transactions involving an electronic logbook, the purchaser pro- vides a signature using one of the fol- lowing means: (AA) Signing a device presented by the seller that captures signatures in an electronic format. Such device shall display the notice described in clause (v). Any device used shall pre- serve each signature in a manner that clearly links that signature to the other electronically-captured logbook information relating to the prospective purchaser providing that signature. (BB) Signing a bound paper book. Such bound paper book shall include, for such purchaser, either (aaa) a printed sticker affixed to the bound paper book at the time of sale which either displays the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale, or a unique identifier which can be linked to that electronic informa- tion, or (bbb) a unique identifier which can be linked to that informa- tion and which is written into the book by the seller at the time of sale. The purchaser shall sign adjacent to the printed sticker or written unique identifier related to that sale. Such bound paper book shall display the notice described in clause (v). (CC) Signing a printed document that includes, for such purchaser, the name of each product sold, the quan- tity sold, the name and address of the purchaser, and the date and time of the sale. Such document shall be printed by the seller at the time of the sale. Such document shall con- tain a clearly identified signature line for a purchaser to sign. Such printed document shall display the notice described in clause (v). Each signed document shall be inserted into a binder or other secure means of document storage immediately after the purchaser signs the docu- ment. (II) The seller enters in the logbook the name of the product and the quan- tity sold. Such information may be cap- tured through electronic means, includ- ing through electronic data capture through bar code reader or similar tech- nology. (III) The logbook maintained by the seller includes the prospective pur- chaser’s name, address, and the date and time of the sale, as follows: (aa) If the purchaser enters the infor- mation, the seller must determine that the name entered in the logbook cor- responds to the name provided on such identification and that the date and time entered are correct. (bb) If the seller enters the informa- tion, the prospective purchaser must verify that the information is correct. (cc) Such information may be cap- tured through electronic means, in- cluding through electronic data cap- ture through bar code reader or similar technology. (v) The written or electronic logbook in- cludes, in accordance with criteria of the Attorney General, a notice to purchasers that entering false statements or mis- representations in the logbook, or sup- plying false information or identification that results in the entry of false state- ments or misrepresentations, may subject the purchasers to criminal penalties under section 1001 of title 18, which notice speci- fies the maximum fine and term of impris- onment under such section. (vi) Regardless of whether the logbook entry is written or electronic, the seller maintains each entry in the logbook for not fewer than 2 years after the date on which the entry is made. (vii) In the case of individuals who are responsible for delivering such products into the custody of purchasers or who deal directly with purchasers by obtaining pay- ments for the products, the seller has sub- mitted to the Attorney General a self-cer- tification that all such individuals have, in accordance with criteria under subpara- graph (B)(ii), undergone training provided by the seller to ensure that the individuals understand the requirements that apply under this subsection and subsection (d). (viii) The seller maintains a copy of such certification and records demonstrating that individuals referred to in clause (vii) have undergone the training. (ix) If the seller is a mobile retail ven- dor: (I) The seller complies with clause (i) by placing the product in a locked cabi- net. (II) The seller does not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenyl- propanolamine base in such products per customer during a 30-day period. Page 835 TITLE 21—FOOD AND DRUGS § 830 (B) Additional provisions regarding certifi- cations and training (i) In general A regulated seller may not sell any scheduled listed chemical product at retail unless the seller has submitted to the At- torney General the self-certification re- ferred to in subparagraph (A)(vii). The cer- tification is not effective for purposes of the preceding sentence unless, in addition to provisions regarding the training of in- dividuals referred to in such subparagraph, the certification includes a statement that the seller understands each of the require- ments that apply under this paragraph and under subsection (d) and agrees to comply with the requirements. (ii) Issuance of criteria; self-certification The Attorney General shall by regula- tion establish criteria for certifications under this paragraph. The criteria shall— (I) provide that the certifications are self-certifications provided through the program under clause (iii); (II) provide that a separate certifi- cation is required for each place of busi- ness at which a regulated seller sells scheduled listed chemical products at re- tail; and (III) include criteria for training under subparagraph (A)(vii). (iii) Program for regulated sellers The Attorney General shall establish a program regarding such certifications and training in accordance with the following: (I) The program shall be carried out through an Internet site of the Depart- ment of Justice and such other means as the Attorney General determines to be appropriate. (II) The program shall inform regu- lated sellers that section 1001 of title 18 applies to such certifications. (III) The program shall make available to such sellers an explanation of the cri- teria under clause (ii). (IV) The program shall be designed to permit the submission of the certifi- cations through such Internet site. (V) The program shall be designed to automatically provide the explanation referred to in subclause (III), and an ac- knowledgement that the Department has received a certification, without requir- ing direct interactions of regulated sell- ers with staff of the Department (other than the provision of technical assist- ance, as appropriate). (iv) Availability of certification to State and local officials Promptly after receiving a certification under subparagraph (A)(vii), the Attorney General shall make available a copy of the certification to the appropriate State and local officials. (v) Publication of list of self-certified per- sons The Attorney General shall develop and make available a list of all persons who are currently self-certified in accordance with this section. This list shall be made publicly available on the website of the Drug Enforcement Administration in an electronically downloadable format. (C) Privacy protections In order to protect the privacy of individ- uals who purchase scheduled listed chemical products, the Attorney General shall by reg- ulation establish restrictions on disclosure of information in logbooks under subpara- graph (A)(iii). Such regulations shall— (i) provide for the disclosure of the infor- mation as appropriate to the Attorney General and to State and local law en- forcement agencies; and (ii) prohibit accessing, using, or sharing information in the logbooks for any pur- pose other than to ensure compliance with this subchapter or to facilitate a product recall to protect public health and safety. (D) False statements or misrepresentations by purchasers For purposes of section 1001 of title 18, en- tering information in the logbook under sub- paragraph (A)(iii) shall be considered a mat- ter within the jurisdiction of the executive, legislative, or judicial branch of the Govern- ment of the United States. (E) Good faith protection A regulated seller who in good faith re- leases information in a logbook under sub- paragraph (A)(iii) to Federal, State, or local law enforcement authorities is immune from civil liability for such release unless the re- lease constitutes gross negligence or inten- tional, wanton, or willful misconduct. (F) Inapplicability of requirements to certain sales Subparagraph (A) does not apply to the sale at retail of a scheduled listed chemical product if a report on the sales transaction is required to be submitted to the Attorney General under subsection (b)(3). (G) Certain measures regarding theft and di- version A regulated seller may take reasonable measures to guard against employing indi- viduals who may present a risk with respect to the theft and diversion of scheduled listed chemical products, which may include, not- withstanding State law, asking applicants for employment whether they have been convicted of any crime involving or related to such products or controlled substances. (2) Mail-order reporting; verification of iden- tity of purchaser; 30-day restriction on quantities for individual purchasers Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to sub- mit a report of the sales transaction to the At- torney General is subject to the following: (A) The person shall, prior to shipping the product, confirm the identity of the pur- chaser in accordance with procedures estab- lished by the Attorney General. The Attor- Page 836 TITLE 21—FOOD AND DRUGS § 830 ney General shall by regulation establish such procedures. (B) The person may not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day pe- riod. (C) Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales trans- action to the Attorney General may not sell any scheduled listed chemical product at re- tail unless such regulated person has sub- mitted to the Attorney General a self-cer- tification including a statement that the seller understands each of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements. The Attorney General shall by regulation establish criteria for certifi- cations of mail-order distributors that are consistent with the criteria established for the certifications of regulated sellers under paragraph (1)(B). (3) Exemptions for certain products Upon the application of a manufacturer of a scheduled listed chemical product, the Attor- ney General may by regulation provide that the product is exempt from the provisions of subsection (d) and paragraphs (1) and (2) of this subsection if the Attorney General deter- mines that the product cannot be used in the illicit manufacture of methamphetamine. (Pub. L. 91–513, title II, § 310, as added Pub. L. 95–633, title II, § 202(a), Nov. 10, 1978, 92 Stat. 3774; amended Pub. L. 100–690, title VI, § 6052(a), Nov. 18, 1988, 102 Stat. 4312; Pub. L. 103–200, §§ 2(c), 10, Dec. 17, 1993, 107 Stat. 2336, 2341; Pub. L. 104–237, title II, § 208, title IV, § 402, Oct. 3, 1996, 110 Stat. 3104, 3111; Pub. L. 106–310, div. B, title XXXVI, § 3652, Oct. 17, 2000, 114 Stat. 1239; Pub. L. 109–177, title VII, §§ 711(a)(2)(B), (b)(1), (c)(1), (2), (d), 716(b)(2), Mar. 9, 2006, 120 Stat. 257, 261, 267; Pub. L. 110–415, § 2, Oct. 14, 2008, 122 Stat. 4349; Pub. L. 111–268, §§ 2, 3, Oct. 12, 2010, 124 Stat. 2847.) Editorial Notes REFERENCES IN TEXT The Food, Drug, and Cosmetic Act, referred to in sub- sec. (b)(3)(A)(i), probably means the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables. This subchapter, referred to in subsecs. (b)(3)(D)(vi), (E) and (e)(1)(C)(ii), was in the original ‘‘this title’’, meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the ‘‘Controlled Sub- stances Act’’. For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables. Subchapter II, referred to in subsecs. (b)(3)(D)(iv), (E) and (c)(2)(A), (B), was in the original ‘‘title III’’, mean- ing title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chap- ter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables. AMENDMENTS 2010—Subsec. (e)(1)(B)(v). Pub. L. 111–268, § 3, added cl. (v). Subsec. (e)(2)(C). Pub. L. 111–268, § 2, added subpar. (C). 2008—Subsec. (e)(1)(A)(iv) to (vi). Pub. L. 110–415 added cls. (iv) to (vi) and struck out former cls. (iv) to (vi) which related to procedures for sales subject to the logbook requirement. 2006—Subsec. (b)(3)(D)(ii). Pub. L. 109–177, § 711(c)(2), inserted ‘‘, except that this clause does not apply to sales of scheduled listed chemical products at retail’’ before period at end. Pub. L. 109–177, § 711(a)(2)(B), substituted ‘‘section 802(49)’’ for ‘‘section 802(46)’’. Subsec. (b)(3)(D)(v). Pub. L. 109–177, § 716(b)(2), sub- stituted ‘‘section 971(f)(2)’’ for ‘‘section 971(e)(2)’’. Subsec. (d). Pub. L. 109–177, § 711(b)(1), added subsec. (d). Subsec. (e)(1). Pub. L. 109–177, § 711(b)(1), added subsec. heading and par. (1). Subsec. (e)(2). Pub. L. 109–177, § 711(c)(1), added par. (2). Subsec. (e)(3). Pub. L. 109–177, § 711(d), added par. (3). 2000—Subsec. (b)(3). Pub. L. 106–310 added subpars. (A), (D), and (E), redesignated former subpars. (A) and (B) as (B) and (C), respectively, and inserted ‘‘or who engages in an export transaction’’ after ‘‘nonregulated person’’ in introductory provisions of subpar. (B). 1996—Subsec. (a)(1). Pub. L. 104–237, § 208, substituted ‘‘for two years after the date of the transaction.’’ for the dash after ‘‘record of the transaction’’ and struck out subpars. (A) and (B) which read as follows: ‘‘(A) for 4 years after the date of the transaction, if the listed chemical is a list I chemical or if the trans- action involves a tableting machine or an encap- sulating machine; and ‘‘(B) for 2 years after the date of the transaction, if the listed chemical is a list II chemical.’’ Subsec. (b)(3). Pub. L. 104–237, § 402, added par. (3). 1993—Subsec. (a)(1). Pub. L. 103–200, § 2(c)(1), sub- stituted ‘‘list I chemical’’ for ‘‘precursor chemical’’ in subpar. (A) and ‘‘a list II chemical’’ for ‘‘an essential chemical’’ in subpar. (B). Subsec. (b). Pub. L. 103–200, § 10, designated existing provisions as par. (1), redesignated former pars. (1) to (4) as subpars. (A) to (D), respectively, in concluding provisions, substituted ‘‘subparagraph (A)’’ for ‘‘para- graph (1)’’ in two places, ‘‘subparagraph (B)’’ for ‘‘para- graph (2)’’, and ‘‘subparagraph (C)’’ for ‘‘paragraph (3)’’, and added par. (2). Subsec. (c)(2)(D). Pub. L. 103–200, § 2(c)(2), substituted ‘‘chemical control laws’’ for ‘‘precursor chemical laws’’. 1988—Pub. L. 100–690 amended section generally, sub- stituting provisions relating to regulation of listed chemicals and certain machines for provisions relating to reporting by any person who distributes, sells, or im- ports any piperidine. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2010 AMENDMENT Pub. L. 111–268, § 6(a), Oct. 12, 2010, 124 Stat. 2848, pro- vided that: ‘‘This Act [amending this section and sec- tion 842 of this title and enacting provisions set out as notes under this section and section 801 of this title] and the amendments made by this Act shall take effect 180 days after the date of enactment of this Act [Oct. 12, 2010].’’ EFFECTIVE DATE OF 2006 AMENDMENT Pub. L. 109–177, title VII, § 711(b)(2), Mar. 9, 2006, 120 Stat. 261, provided that: ‘‘With respect to subsections (d) and (e)(1) of section 310 of the Controlled Substances Act [21 U.S.C. 830(d), (e)(1)], as added by paragraph (1) of this subsection: ‘‘(A) Such subsection (d) applies on and after the expiration of the 30-day period beginning on the date of the enactment of this Act [Mar. 9, 2006]. ‘‘(B) Such subsection (e)(1) applies on and after Sep- tember 30, 2006.’’ Page 837 TITLE 21—FOOD AND DRUGS § 831 Pub. L. 109–177, title VII, § 711(c)(3), Mar. 9, 2006, 120 Stat. 261, provided that: ‘‘The amendments made by paragraphs (1) and (2) [amending this section] apply on and after the expiration of the 30-day period beginning on the date of the enactment of this Act [Mar. 9, 2006].’’ EFFECTIVE DATE OF 1993 AMENDMENT Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title. EFFECTIVE DATE; TIME TO SUBMIT PIPERIDINE REPORT; REQUIRED INFORMATION Pub. L. 95–633, title II, § 203(a), Nov. 10, 1978, 92 Stat. 3776, provided that: ‘‘(1) Except as provided under paragraph (2), the amendments made by this title [enacting this section and amending sections 841 to 843 of this title] shall take effect on the date of the enactment of this Act [Nov. 10, 1978]. ‘‘(2) Any person required to submit a report under section 310(a)(1) of the Controlled Substances Act [sub- sec. (a)(1) of this section] respecting a distribution, sale, or importation of piperidine during the 90 days after the date of the enactment of this Act [Nov. 10, 1978] may submit such report any time up to 97 days after such date of enactment. ‘‘(3) Until otherwise provided by the Attorney Gen- eral by regulation, the information required to be re- ported by a person under section 310(a)(1) of the Con- trolled Substances Act (as added by section 202(a)(2) of this title) [subsec. (a)(1) of this section] with respect to the person’s distribution, sale, or importation of piper- idine shall— ‘‘(A) be the information described in subparagraphs (A) and (B) of such section, and ‘‘(B) except as provided in paragraph (2) of this sub- section, be reported not later than seven days after the date of such distribution, sale, or importation.’’ REPEALS Pub. L. 96–359, § 8(b), Sept. 26, 1980, 94 Stat. 1194, re- pealed section 203(d) of Pub. L. 95–633, which had pro- vided for the repeal of this section effective Jan. 1, 1981. REGULATIONS Pub. L. 111–268, § 6(b), Oct. 12, 2010, 124 Stat. 2848, pro- vided that: ‘‘In promulgating the regulations author- ized by section 2 [amending this section], the Attorney General may issue regulations on an interim basis as necessary to ensure the implementation of this Act by the effective date [see Effective Date of 2010 Amend- ment note above].’’ Pub. L. 95–633, title II, § 203(b), Nov. 10, 1978, 92 Stat. 3777, required the Attorney General to publish proposed interim regulations for piperidine reporting under sec- tion 830(a) of this title not later than 30 days after en- actment, and final interim regulations not later than 75 days after enactment, such final interim regulations to be effective on and after the ninety-first day after enactment. REPORT TO PRESIDENT AND CONGRESS ON EFFECTIVENESS OF TITLE II OF PUB. L. 95–633 Pub. L. 95–633, title II, § 203(c), Nov. 10, 1978, 92 Stat. 3777, required the Attorney General to analyze and evaluate the impact and effectiveness of the amend- ments made by title II of Pub. L. 95–633, and report to the President and Congress not later than Mar. 1, 1980. § 831. Additional requirements relating to online pharmacies and telemedicine (a) In general An online pharmacy shall display in a visible and clear manner on its homepage a statement that it complies with the requirements of this section with respect to the delivery or sale or offer for sale of controlled substances and shall at all times display on the homepage of its Internet site a declaration of compliance in ac- cordance with this section. (b) Licensure Each online pharmacy shall comply with the requirements of State law concerning the licen- sure of pharmacies in each State from which it, and in each State to which it, delivers, distrib- utes, or dispenses or offers to deliver, distribute, or dispense controlled substances by means of the Internet, pursuant to applicable licensure requirements, as determined by each such State. (c) Internet pharmacy site disclosure informa- tion Each online pharmacy shall post in a visible and clear manner on the homepage of each Internet site it operates, or on a page directly linked thereto in which the hyperlink is also visible and clear on the homepage, the following information for each pharmacy that delivers, distributes, or dispenses controlled substances pursuant to orders made on, through, or on be- half of, that website: (1) The name and address of the pharmacy as it appears on the pharmacy’s Drug Enforce- ment Administration certificate of registra- tion. (2) The pharmacy’s telephone number and email address. (3) The name, professional degree, and States of licensure of the pharmacist-in- charge, and a telephone number at which the pharmacist-in-charge can be contacted. (4) A list of the States in which the phar- macy is licensed to dispense controlled sub- stances. (5) A certification that the pharmacy is reg- istered under this part to deliver, distribute, or dispense by means of the Internet con- trolled substances. (6) The name, address, telephone number, professional degree, and States of licensure of any practitioner who has a contractual rela- tionship to provide medical evaluations or issue prescriptions for controlled substances, through referrals from the website or at the request of the owner or operator of the website, or any employee or agent thereof. (7) The following statement, unless revised by the Attorney General by regulation: ‘‘This online pharmacy will only dispense a con- trolled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation or medical evaluation via telemedicine in ac- cordance with applicable requirements of sec- tion 309.’’. (d) Notification (1) In general Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing, the online pharmacy shall notify the Attorney General, in such form and man- ner as the Attorney General shall determine,