HHS 21 CFR PART 1314-2011 RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS《计划列出的化学产品的零售》.pdf

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1、205 Drug Enforcement Administration, Justice 1314.02 1313.54 Request for hearing. (a) Any person entitled to a hearing pursuant to 1313.52 and desiring a hearing shall, within 30 days after re-ceipt of the notice to suspend the ship-ment, file with the Administrator a written request for a hearing i

2、n the form prescribed in 1316.47 of this chap-ter. (b) If any person entitled to a hearing or to participate in a hearing pursuant to 1313.41 fails to file a request for a hearing or a notice of appearance, or if he so files and fails to appear at the hearing, he shall be deemed to have waived his o

3、pportunity for the hearing or to participate in the hearing, unless he shows good cause for such failure. (c) If all persons entitled to a hearing or to participate in a hearing waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Administrator may can

4、cel the hearing, if scheduled, and issue his final order pursuant to 1313.57. 1313.55 Burden of proof. At any hearing regarding the suspen-sion of shipments, the Agency shall have the burden of proving that the re-quirements of this part for such sus-pension are satisfied. 1313.56 Time and place of

5、hearing. (a) If any regulated person requests a hearing on the suspension of ship-ments, a hearing will be scheduled no later than 45 days after the request is made, unless the regulated person re-quests an extension to this date. (b) The hearing will commence at the place and time designated in the

6、 notice given pursuant to paragraph (a) of this section but thereafter it may be moved to a different place and may be contin-ued from day to day or recessed to a later day without notice other than an-nouncement thereof by the presiding officer at the hearing. 1313.57 Final order. As soon as practi

7、cable after the pre-siding officer has certified the record to the Administrator, the Adminis-trator shall issue his order regarding the suspension of shipment. The order shall include the findings of fact and conclusions of law upon which the order is based. The Administrator shall serve one copy o

8、f his order upon each party in the hearing. PART 1314RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS Subpart AGeneral Sec. 1314.01 Scope. 1314.02 Applicability. 1314.03 Definitions. 1314.05 Requirements regarding packaging of nonliquid forms. 1314.10 Effect on state laws. 1314.15 Loss reporting. S

9、ubpart BSales by Regulated Sellers 1314.20 Restrictions on sales quantity. 1314.25 Requirements for retail trans-actions. 1314.30 Recordkeeping for retail trans-actions. 1314.35 Training of sales personnel. 1314.40 Self-certification. 1314.42 Self-certification fee; time and method of fee payment. 1

10、314.45 Privacy protections. 1314.50 Employment measures. Subpart CMail-Order Sales 1314.100 Sales limits for mail-order sales. 1314.105 Verification of identity for mail- order sales. 1314.110 Reports for mail-order sales. 1314.115 Distributions not subject to report-ing requirements. Subpart DOrder

11、 To Show Cause 1314.150 Order to show cause. 1314.155 Suspension pending final order. AUTHORITY: 21 U.S.C. 802, 830, 842, 871(b), 875, 877, 886a. SOURCE: 71 FR 56024, Sept. 26, 2006, unless otherwise noted. Subpart AGeneral 1314.01 Scope. This part specifies the requirements for retail sales of sche

12、duled listed chemical products to individuals for personal use. 1314.02 Applicability. (a) This part applies to the following regulated persons who sell scheduled VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00215 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with C

13、FRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-206 21 CFR Ch. II (4111 Edition) 1314.03 listed chemical products for personal use: (1) Regulated sellers of scheduled listed chemical products sold at retail for personal use through face-to-face sal

14、es at stores or mobile retail vendors. (2) Regulated persons who engage in a transaction with a non-regulated per-son and who ship the products to the non-regulated person by the U.S. Post-al Service or by private or common carriers. (b) The requirements in subpart A apply to all regulated persons s

15、ubject to this part. The requirements in sub-part B apply to regulated sellers as de-fined in 1300.02 of this chapter. The re-quirements in subpart C apply to regu-lated persons who ship the products to the customer by the U.S. Postal Serv-ice or by private or common carriers. 1314.03 Definitions. A

16、s used in this part, the term mail- order sale means a retail sale of scheduled listed chemical products for personal use where a regulated person uses or attempts to use the U.S. Postal Service or any private or commercial carrier to deliver the product to the customer. Mail-order sale includes pur

17、-chase orders submitted by phone, mail, fax, Internet, or any method other than face-to-face transaction. 1314.05 Requirements regarding packaging of nonliquid forms. A regulated seller or mail order dis-tributor may not sell a scheduled listed chemical product in nonliquid form (in-cluding gel caps

18、) unless the product is packaged either in blister packs, with each blister containing no more than two dosage units or, if blister packs are technically infeasible, in unit dose packets or pouches. 1314.10 Effect on State laws. Nothing in this part preempts State law on the same subject matter unle

19、ss there is a positive conflict between this part and a State law so that the two cannot consistently stand together. 1314.15 Loss reporting. (a) Each regulated person must re-port to the Special Agent in Charge of the DEA Divisional Office for the area in which the regulated person making the repor

20、t is located, any unusual or excessive loss or disappearance of a scheduled listed chemical product under the control of the regulated per-son. The regulated person responsible for reporting a loss in-transit is the supplier. (b) Each report submitted under paragraph (a) of this section must, whenev

21、er possible, be made orally to the DEA Divisional Office for the area in which the regulated person making the report is located at the earliest practicable opportunity after the regu-lated person becomes aware of the cir-cumstances involved. (c) Written reports of losses must be filed within 15 day

22、s after the regulated person becomes aware of the cir-cumstances of the event. (d) A report submitted under this sec-tion must include a description of the circumstances of the loss (in-transit, theft from premises, etc.). (e) A suggested format for the report is provided below: Regulated Person Reg

23、istration number (if applicable) llllName llllllllllllllllllllBusiness address llllllllllllllCity lllllllllllllllllllllState llllllllllllllllllllZip lllllllllllllllllllllBusiness phone lllllllllllllllDate of loss lllllllllllllllllType of loss lllllllllllllllllDescription of circumstances llllllllSub

24、part BSales by Regulated Sellers 1314.20 Restrictions on sales quan-tity. (a) Without regard to the number of transactions, a regulated seller (includ-ing a mobile retail vendor) may not in a single calendar day sell any pur-chaser more than 3.6 grams of ephed-rine base, 3.6 grams of pseudoephedrine

25、 base, or 3.6 grams of phenylpropanola-mine base in scheduled listed chemical products. (b) A mobile retail vendor may not in any 30-day period sell an individual purchaser more than 7.5 grams of ephedrine base, 7.5 grams of pseudoephedrine base, or 7.5 grams of phenylpropanolamine base in scheduled

26、 listed chemical products. VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00216 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-207 Drug Enforcement Administration,

27、 Justice 1314.30 1314.25 Requirements for retail transactions. (a) Each regulated seller must ensure that sales of a scheduled listed chem-ical product at retail are made in ac-cordance with this section and 1314.20. (b) The regulated seller must place the product so that customers do not have direc

28、t access to the product be-fore the sale is made (in this paragraph referred to as behind-the-counter placement). For purposes of this para-graph, a behind-the-counter placement of a product includes circumstances in which the product is stored in a locked cabinet that is located in an area of the f

29、acility where customers do have direct access. Mobile retail vendors must place the product in a locked cabinet. (c) The regulated seller must deliver the product directly into the custody of the purchaser. 1314.30 Recordkeeping for retail transactions. (a)(1) Except for purchase by an indi-vidual o

30、f a single sales package con-taining not more than 60 milligrams of pseudoephedrine, the regulated seller must maintain, in accordance with cri-teria issued by the Administrator, a written or electronic list of each sched-uled listed chemical product sale that identifies the products by name, the qu

31、antity sold, the names and addresses of the purchasers, and the dates and times of the sales (referred to as the logbook). The logbook may be main-tained on paper or in electronic form. (2) Effective November 27, 2006, if a logbook is maintained on paper, it must be created and maintained in a bound

32、 record book. (b) The regulated seller must not sell a scheduled listed chemical product at retail unless the purchaser does the fol-lowing: (1) 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 identi

33、fication, is considered acceptable for purposes of 8 CFR 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B). (2) Signs the logbook and enters in the logbook his or her name, address, and the date and time of the sale. (c) For records created electroni-cally, the regulated seller may use an electronic signatu

34、re system to capture the signature and may have the com-puter automatically enter the date and time of the sale. The regulated seller may ask the purchaser for their name and address and enter information if it is not feasible for the purchaser to enter the information electronically. (d) The regula

35、ted seller must deter-mine that the name entered in the log-book corresponds to the name provided on identification presented and that the date and time entered are correct. (e) The regulated seller must enter in the logbook the name of the product and the quantity sold. Examples of methods of recor

36、ding the quantity sold include the weight of the product per package and number of packages of each chemical, the cumulative weight of the product for each chemical, or quantity of product by Universal Prod-uct Code. These examples do not ex-clude other methods of displaying the quantity sold. For e

37、lectronic records, the regulated seller may use a point-of- sale and bar code reader. Such elec-tronic records must be provided pursu-ant to paragraph (i) of this section in a human readable form such that the re-quirements of paragraph (a)(1) of this section are satisfied. (f) The regulated seller

38、must include in the logbook or display by the log-book, the following notice: WARNING: Section 1001 of Title 18, United States Code, states that whoever, with re-spect to the logbook, knowingly and will-fully falsifies, conceals, or covers up by any trick, scheme, or device a material fact, or makes

39、 any materially false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined not more than $250,000 if an individual or $500,000 if an organi

40、zation, imprisoned not more than five years, or both. (g) The regulated seller must main-tain each entry in the logbook for not fewer than 2 years after the date on which the entry is made. (h) A record under this section must be kept at the regulated sellers place of business where the transaction

41、oc-curred, except that records may be kept at a single, central location of the regulated seller if the regulated seller has notified the Administration of the VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00217 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRP

42、rovided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-208 21 CFR Ch. II (4111 Edition) 1314.35 intention to do so. Written notification must be submitted by registered or cer-tified mail, return receipt requested, to the Special Agent in Charge of the DEA D

43、ivisional Office for the area in which the records are required to be kept. (i) The records required to be kept under this section must be readily re-trievable and available for inspection and copying by authorized employees of the Administration under the provi-sions of 21 U.S.C. 880. (j) A record

44、developed and main-tained to comply with a State law may be used to meet the requirements of this section if the record includes the information specified in this section. 1314.35 Training of sales personnel. Each regulated seller must ensure that its sales of a scheduled listed chemical product at

45、retail are made in accordance with the following: (a) In the case of individuals who are responsible for delivering the products into the custody of purchasers or who deal directly with purchasers by ob-taining payments for the products, the regulated seller has submitted to the Administration a sel

46、f-certification that all such individuals have, in ac-cordance with criteria issued by the Administration, undergone training provided by the regulated seller to en-sure that the individuals understand the requirements that apply under this part. (b) The regulated seller maintains a copy of each sel

47、f-certification and all records demonstrating that individuals referred to in paragraph (a) of this sec-tion have undergone the training. 1314.40 Self-certification. (a) A regulated seller must submit to the Administration the self-certifi-cation referred to in 1314.35(a) in order to sell any schedu

48、led listed chemical product. The certification is not effec-tive for purposes of this section unless, in addition to provisions regarding the training of individuals referred to in 1314.35(a), the certification includes a statement that the regulated seller un-derstands each of the requirements that

49、 apply under this part and agrees to comply with the requirements. (b) When a regulated seller files the initial self-certification, the Adminis-tration will assign the regulated seller to one of twelve groups. The expiration date of the self-certification for all reg-ulated sellers in any group will be the last day of the month designated for that group. In assigning a regulated seller to a group, the Administration may select a gro