IIB 

113TH CONGRESS 

1ST SESSION H. R. 1919 

IN THE SENATE OF THE UNITED STATES 

JUNE 4, 2013 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to the pharmaceutical distribution supply chain, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Safeguarding America’s Pharmaceuticals Act of 2013’’. 

4 (b) TABLE OF CONTENTS.—The table of contents of 

5 this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Pharmaceutical distribution supply chain. 

Sec. 3. Enhanced drug distribution security. 

Sec. 4. National standards for wholesale distributors. 

Sec. 5. National licensure standards for third-party logistics providers. 

Sec. 6. Penalties. 

Sec. 7. Uniform national policy. 

Sec. 8 Electronic labeling. 

6 SEC. 2. PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN. 

7 Chapter V of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 351 et seq.) is amended by adding at the 

9 end the following: 

10 ‘‘Subchapter H—Pharmaceutical Distribution 

11 Supply Chain 

12 ‘‘SEC. 581. DEFINITIONS. 

13 ‘‘In this subchapter: 

14 ‘‘(1) AUTHORIZED.—The term ‘authorized’ 

15 means— 

16 ‘‘(A) in the case of a manufacturer or re17 packager, having a valid registration in accord18 ance with section 510; and 

19 ‘‘(B) in the case of a wholesale distributor, 

20 third-party logistics provider, or dispenser, li21 censed (as defined in this section). 

22 ‘‘(2) DISPENSER.—The term ‘dispenser’— 


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1 ‘‘(A) subject to subparagraph (C), means a 

2 retail pharmacy, hospital pharmacy, a group of 

3 chain pharmacies under common ownership and 

4 control, or any other person authorized by law 

5 to dispense or administer prescription drugs, to 

6 the extent such pharmacy, group, or person 

7 does not act as a wholesale distributor; 

8 ‘‘(B) includes warehouses and distribution 

9 centers under common ownership or control of 

10 entities described in subparagraph (A) that are 

11 members of an affiliated group pursuant to sec12 tion 1504(a) of the Internal Revenue Code of 

13 1986, to the extent such warehouses and dis14 tribution centers do not act as a wholesale dis15 tributor; and 

16 ‘‘(C) does not include a person who only 

17 dispenses prescription drug product to be used 

18 in animals in accordance with section 

19 512(a)(5). 

20 ‘‘(3) DISPOSITION.—The term ‘disposition’, 

21 with respect to a prescription drug product within 

22 the possession and control of an entity— 

23 ‘‘(A) means the removal of such prescrip24 tion drug product, or taking measures to pre25 vent the introduction of such prescription drug 


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1 product, from the pharmaceutical distribution 

2 supply chain; and 

3 ‘‘(B) may include disposal, return of the 

4 prescription drug product for disposal, or other 

5 appropriate handling and other actions such as 

6 retaining a sample of the prescription drug 

7 product for additional physical examination or 

8 laboratory analysis by a manufacturer or regu9 latory or law enforcement agency. 

10 ‘‘(4) DISTRIBUTE OR DISTRIBUTION.—The 

11 terms ‘distribute’ and ‘distribution’ mean the sale, 

12 purchase, trade, delivery, handling, or storage of a 

13 prescription drug product. 

14 ‘‘(5) ILLEGITIMATE PRESCRIPTION DRUG PROD15 UCT.—The term ‘illegitimate prescription drug prod16 uct’ means a prescription drug product which a 

17 manufacturer has confirmed— 

18 ‘‘(A) is counterfeit, diverted, or stolen; 

19 ‘‘(B) is intentionally adulterated such that 

20 the prescription drug product would result in 

21 serious adverse health consequences or death to 

22 humans; or 

23 ‘‘(C) is otherwise unfit for distribution 

24 such that the prescription drug product is reaVerDate Mar 15 2010 00:07 Jun 05, 2013 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.RFS H1919

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1 sonably likely to cause serious adverse human 

2 health consequences or death. 

3 ‘‘(6) LICENSED.—The term ‘licensed’ means— 

4 ‘‘(A) in the case of a wholesale distributor, 

5 having a valid license to make wholesale dis6 tributions consistent with the standards under 

7 section 583; 

8 ‘‘(B) in the case of a third-party logistics 

9 provider, having a valid license to engage in the 

10 activities of a third-party logistics provider in 

11 accordance with section 584; and 

12 ‘‘(C) in the case of a dispenser, having a 

13 valid license to dispense prescription drugs 

14 under State law. 

15 ‘‘(7) MANUFACTURER.—The term ‘manufac16 turer’ means, with respect to a prescription drug 

17 product— 

18 ‘‘(A) a person that holds an application ap19 proved under section 505 or a license issued 

20 under section 351 of the Public Health Service 

21 Act for such prescription drug product, or if 

22 such prescription drug product is not the sub23 ject of an approved application or license, the 

24 person who manufactured the prescription drug 

25 product; 


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1 ‘‘(B) a co-licensed partner of the person 

2 described in subparagraph (A) that obtains the 

3 prescription drug product directly from the per4 son described in such subparagraph; or 

5 ‘‘(C) a person that— 

6 ‘‘(i) is a member of an affiliated 

7 group (as defined in section 1504(a) of the 

8 Internal Revenue Code of 1986) to which 

9 a person described in subparagraph (A) or 

10 (B) is also a member; and 

11 ‘‘(ii) receives the prescription drug 

12 product directly from a person described in 

13 subparagraph (A) or (B). 

14 ‘‘(8) PACKAGE.— 

15 ‘‘(A) IN GENERAL.—The term ‘package’ 

16 means the smallest individual saleable unit of 

17 prescription drug product for distribution in 

18 interstate commerce by a manufacturer or re19 packager that is intended by the manufacturer 

20 for ultimate sale to the dispenser of such pre21 scription drug product. 

22 ‘‘(B) INDIVIDUAL SALEABLE UNIT.—The 

23 term ‘individual saleable unit’ means the small24 est container of prescription drug product intro25 duced into interstate commerce by the manufacVerDate Mar 15 2010 00:07 Jun 05, 2013 Jkt 029200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.RFS H1919

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1 turer or repackager that is intended by the 

2 manufacturer for individual sale to a dispenser. 

3 ‘‘(9) PRESCRIPTION DRUG.—The term ‘pre4 scription drug’ means a drug for human use subject 

5 to section 503(b)(1). 

6 ‘‘(10) PRESCRIPTION DRUG PRODUCT.—The 

7 term ‘prescription drug product’ means a prescrip8 tion drug in a finished dosage form for administra9 tion to a patient without substantial further manu10 facturing (such as capsules, tablets, and lyophilized 

11 prescription drug products before reconstitution). 

12 ‘‘(11) PRESCRIPTION DRUG PRODUCT IDENTI13 FIER.—The term ‘prescription drug product identi14 fier’ means a standardized graphic that— 

15 ‘‘(A) includes the standardized numerical 

16 identifier, lot number, and expiration date of a 

17 prescription drug product; and 

18 ‘‘(B) is in both human-readable form and 

19 on a machine-readable data carrier that con20 forms to the standards developed by a widely 

21 recognized international standards development 

22 organization. 

23 ‘‘(12) QUARANTINE.—The term ‘quarantine’ 

24 means to store or identify a product, for the purpose 

25 of preventing distribution or transfer of the product, 


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1 in a physically separate area clearly identified for 

2 such use, or through use of other procedures such 

3 as automated designation. 

4 ‘‘(13) REPACKAGER.—The term ‘repackager’ 

5 means a person who owns or operates an establish6 ment that repacks and relabels a prescription drug 

7 product or package for further sale or distribution. 

8 ‘‘(14) RETURN.—The term ‘return’ means pro9 viding prescription drug product to the authorized 

10 trading partner or trading partners from which such 

11 prescription drug product was purchased or received, 

12 or to a returns processor for handling of such pre13 scription drug product. 

14 ‘‘(15) RETURNS PROCESSOR.—The terms ‘re15 turns processor’ mean a person who owns or oper16 ates an establishment that provides for the disposi17 tion of or otherwise processes saleable and nonsale18 able prescription drug product received from an au19 thorized trading partner such that the prescription 

20 drug product may be processed for credit to the pur21 chaser, manufacturer, seller, or disposed of for no 

22 further distribution. 

23 ‘‘(16) SPECIFIC PATIENT NEED.—The term 

24 ‘specific patient need’— 


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1 ‘‘(A) means with respect to the transfer of 

2 a prescription drug product from one pharmacy 

3 to another, to fill a prescription for an identi4 fied patient; and 

5 ‘‘(B) does not include the transfer of a 

6 prescription drug product from one pharmacy 

7 to another for the purpose of increasing or re8 plenishing stock in anticipation of a potential 

9 need. 

10 ‘‘(17) STANDARDIZED NUMERICAL IDENTI11 FIER.—The term ‘standardized numerical identifier’ 

12 means a set of numbers or characters that— 

13 ‘‘(A) is used to uniquely identify each 

14 package or homogenous case of the prescription 

15 drug product; and 

16 ‘‘(B) is composed of the National Drug 

17 Code that corresponds to the specific prescrip18 tion drug product (including the particular 

19 package configuration) combined with a unique 

20 alphanumeric serial number of up to 20 char21 acters. 

22 ‘‘(18) SUSPECT PRESCRIPTION DRUG PROD23 UCT.—The term ‘suspect prescription drug product’ 

24 means a prescription drug product for which there 


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1 is reason to believe that such prescription drug prod2 uct— 

3 ‘‘(A) is potentially counterfeit, diverted, or 

4 stolen; 

5 ‘‘(B) is potentially intentionally adulterated 

6 such that the prescription drug product would 

7 result in serious adverse health consequences or 

8 death to humans; or 

9 ‘‘(C) appears otherwise unfit for distribu10 tion such that the prescription drug product 

11 would result in serious adverse health con12 sequences or death to humans. 

13 ‘‘(19) THIRD-PARTY LOGISTICS PROVIDER.— 

14 The term ‘third-party logistics provider’ means an 

15 entity that provides or coordinates warehousing, dis16 tribution, or other logistics services of a prescription 

17 drug product in interstate commerce on behalf of a 

18 manufacturer, wholesale distributor, or dispenser of 

19 a prescription drug product, but does not take own20 ership of the prescription drug product, nor have re21 sponsibility to direct the sale or disposition of, the 

22 prescription drug product. 

23 ‘‘(20) TRADING PARTNER.—The term ‘trading 

24 partner’ means— 


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1 ‘‘(A) a manufacturer, repackager, whole2 sale distributor, or dispenser from whom a 

3 manufacturer, repackager, wholesale dis4 tributor, or dispenser accepts ownership of a 

5 prescription drug product or to whom a manu6 facturer, repackager, wholesale distributor, or 

7 dispenser transfers ownership of a prescription 

8 drug product; or 

9 ‘‘(B) a third-party logistics provider from 

10 whom a manufacturer, repackager, wholesale 

11 distributor, or dispenser accepts possession of a 

12 prescription drug product or to whom a manu13 facturer, repackager, wholesale distributor, or 

14 dispenser transfers possession of a prescription 

15 drug product. 

16 ‘‘(21) TRANSACTION.— 

17 ‘‘(A) IN GENERAL.—The term ‘transaction’ 

18 means the transfer in interstate commerce of 

19 prescription drug product between persons in 

20 which a change of ownership occurs. 

21 ‘‘(B) EXEMPTIONS.—The term ‘trans22 action’ does not include— 

23 ‘‘(i) intracompany distribution of any 

24 prescription drug product, including be25 tween members of an affiliated group (as 


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1 defined in section 1504(a) of the Internal 

2 Revenue Code of 1986); 

3 ‘‘(ii) the distribution of a prescription 

4 drug product among hospitals or other 

5 health care entities that are under common 

6 control; 

7 ‘‘(iii) the distribution of a prescription 

8 drug product for emergency medical rea9 sons including a public health emergency 

10 declaration pursuant to section 319 of the 

11 Public Health Service Act, except that a 

12 drug shortage not caused by a public 

13 health emergency shall not constitute an 

14 emergency medical reason; 

15 ‘‘(iv) the dispensing of a prescription 

16 drug product pursuant to a valid prescrip17 tion executed in accordance with section 

18 503(b)(1); 

19 ‘‘(v) the distribution of prescription 

20 drug product samples by a manufacturer 

21 or a licensed wholesale distributor in ac22 cordance with section 503(d); 

23 ‘‘(vi) the distribution of blood or blood 

24 components intended for transfusion; 


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1 ‘‘(vii) the distribution of minimal 

2 quantities of prescription drug product by 

3 a licensed retail pharmacy to a licensed 

4 practitioner for office use; 

5 ‘‘(viii) the distribution of a prescrip6 tion drug product by a charitable organiza7 tion to a nonprofit affiliate of the organiza8 tion to the extent otherwise permitted by 

9 law; 

10 ‘‘(ix) the distribution of a prescription 

11 drug product pursuant to the sale or merg12 er of a pharmacy or pharmacies or a 

13 wholesale distributor or wholesale distribu14 tors, except that any records required to be 

15 maintained for the prescription drug prod16 uct shall be transferred to the new owner 

17 of the pharmacy or pharmacies or whole18 sale distributor or wholesale distributors; 

19 ‘‘(x) the dispensing of a prescription 

20 drug product approved under section 

21 512(b); 

22 ‘‘(xi) the transfer of prescription drug 

23 products to or from any facility that is li24 censed by the Nuclear Regulatory Commis25 sion or by a State pursuant to an agreeVerDate Mar 15 2010 00:07 Jun 05, 2013 Jkt 029200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.RFS H1919

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1 ment with such Commission under section 

2 274 of the Atomic Energy Act of 1954 (42 

3 U.S.C. 2021); 

4 ‘‘(xii) the distribution of a combina5 tion product that consists of— 

6 ‘‘(I) a product comprised of two 

7 or more components that are each a 

8 drug, biological product, or device and 

9 that are physically, chemically, or oth10 erwise combined or mixed and pro11 duced as a single entity; 

12 ‘‘(II) two or more separate prod13 ucts packaged together in a single 

14 package or as a unit and comprised of 

15 a drug and device or a device and bio16 logical product; or 

17 ‘‘(III) two or more finished de18 vices plus one or more drug or biologi19 cal products which are packaged to20 gether in a medical convenience kit 

21 described in clause (xiii); 

22 ‘‘(xiii) the distribution of a medical 

23 convenience kit which is a collection of fin24 ished products (consisting of devices or 

25 drugs) assembled in kit form strictly for 


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1 the convenience of the purchaser or user 

2 if— 

3 ‘‘(I) the medical convenience kit 

4 is assembled in an establishment that 

5 is registered with the Food and Drug 

6 Administration as a medical device 

7 manufacturer; 

8 ‘‘(II) the person who manufactur9 ers the medical convenience kit pur10 chased the prescription drug product 

11 directly from the manufacturer or 

12 from a wholesale distributor that pur13 chased the prescription drug product 

14 directly from the manufacturer; 

15 ‘‘(III) the person who manufac16 turers the medical convenience kit 

17 does not alter the primary container 

18 or label of the prescription drug prod19 uct as purchased from the manufac20 turer or wholesale distributor; 

21 ‘‘(IV) the medical convenience kit 

22 does not contain a controlled sub23 stance (as defined in section 102 of 

24 the Controlled Substances Act); and 


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1 ‘‘(V) the prescription drug prod2 ucts contained in the medical conven3 ience kit are— 

4 ‘‘(aa) intravenous solutions 

5 intended for the replenishment of 

6 fluids and electrolytes; 

7 ‘‘(bb) drugs intended to 

8 maintain the equilibrium of water 

9 and minerals in the body; 

10 ‘‘(cc) drugs intended for irri11 gation or reconstitution; 

12 ‘‘(dd) anesthetics; 

13 ‘‘(ee) anticoagulants; 

14 ‘‘(ff) vasopressors; or 

15 ‘‘(gg) sympathicomimetics; 

16 ‘‘(xiv) the distribution of an intra17 venous prescription drug product that, by 

18 its formulation, is intended for the replen19 ishment of fluids and electrolytes (such as 

20 sodium, chloride, and potassium) or cal21 ories (such as dextrose and amino acids); 

22 ‘‘(xv) the distribution of an intra23 venous prescription drug product used to 

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1 erals in the body, such as dialysis solu2 tions; 

3 ‘‘(xvi) the distribution of a prescrip4 tion drug product that is intended for irri5 gation or reconstitution, or sterile water, 

6 whether intended for such purposes or for 

7 injection; 

8 ‘‘(xvii) the distribution of compressed 

9 medical gas; or 

10 ‘‘(xviii)(I) the distribution of a prod11 uct by a dispenser, or a wholesale dis12 tributor acting at the direction of the dis13 penser, to a repackager registered under 

14 section 510 for the purpose of repackaging 

15 the drug for use by that dispenser or an16 other health care entity that is under the 

17 dispenser’s ownership or control, so long as 

18 the dispenser retains ownership of the pre19 scription drug product; and 

20 ‘‘(II) the saleable or nonsaleable re21 turn by such repackager of such prescrip22 tion drug product. 

23 ‘‘(C) COMPRESSED MEDICAL GAS.—For 

24 purposes of subparagraph (B)(xvii), the term 

25 ‘compressed medical gas’ means any substance 


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1 in its gaseous or cryogenic liquid form that 

2 meets medical purity standards and has appli3 cation in a medical or homecare environment, 

4 including oxygen and nitrous oxide. 

5 ‘‘(22) TRANSACTION HISTORY.—The term 

6 ‘transaction history’ means a statement that— 

7 ‘‘(A) includes the transaction information 

8 for each transaction conducted with respect to 

9 a prescription drug product beginning with the 

10 manufacturer or initial purchase distributor; 

11 and 

12 ‘‘(B) is in paper or electronic form. 

13 ‘‘(23) TRANSACTION INFORMATION.—The term 

14 ‘transaction information’ means— 

15 ‘‘(A) the proprietary or established name 

16 or names of the prescription drug product; 

17 ‘‘(B) the strength and dosage form of the 

18 prescription drug product; 

19 ‘‘(C) the National Drug Code number of 

20 the prescription drug product; 

21 ‘‘(D) the container size; 

22 ‘‘(E) the number of containers; 

23 ‘‘(F) the lot number of the prescription 

24 drug product; 

25 ‘‘(G) the date of the transaction; 


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1 ‘‘(H) the business name and address of the 

2 person from whom ownership is being trans3 ferred; and 

4 ‘‘(I) the business name and address of the 

5 person to whom ownership is being transferred. 

6 ‘‘(24) TRANSACTION STATEMENT.—The ‘trans7 action statement’ is a statement, which states that 

8 the manufacturer, repackager, wholesale distributor, 

9 third-party logistics provider, or dispenser transfer10 ring ownership in a transaction— 

11 ‘‘(A) is authorized; 

12 ‘‘(B) received transaction information and 

13 a transaction statement as required under sec14 tion 582 from the prior owner of the prescrip15 tion drug product; 

16 ‘‘(C) did not knowingly and intentionally 

17 ship an illegitimate prescription drug product; 

18 ‘‘(D) did not knowingly and intentionally 

19 provide false transaction information; and 

20 ‘‘(E) did not knowingly and intentionally 

21 alter the transaction history. 

22 ‘‘(25) VERIFICATION AND VERIFY.—The terms 

23 ‘verification’ and ‘verify’— 

24 ‘‘(A) mean determining whether the pre25 scription drug product identifier affixed to, or 


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1 imprinted upon, a package or homogeneous case 

2 of the prescription drug product corresponds to 

3 the standardized numerical identifier or lot 

4 number, and expiration date assigned to the 

5 prescription drug product by the manufacturer 

6 or the repackager, as applicable; and 

7 ‘‘(B) include making the determination 

8 under subparagraph (A) using human-readable 

9 or machine-readable methods. 

10 ‘‘(26) WHOLESALE DISTRIBUTOR.—The term 

11 ‘wholesale distributor’— 

12 ‘‘(A) means a person engaged in wholesale 

13 distribution (as defined in section 583); and 

14 ‘‘(B) excludes— 

15 ‘‘(i) a manufacturer, a co-licensed 

16 partner of a manufacturer, or a third-party 

17 logistics provider, or a dispenser who does 

18 not engage in such wholesale distribution; 

19 ‘‘(ii) a repackager engaged in such 

20 wholesale distribution; or 

21 ‘‘(iii) the distribution of prescription 

22 drug product or an offer to distribute pre23 scription drug product by an authorized re24 packager that has taken ownership or pos25 session of the prescription drug product 


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1 and repacked the prescription drug prod2 uct in accordance with the requirements of 

3 section 582(e). 

4 ‘‘SEC. 582. REQUIREMENTS. 

5 ‘‘(a) IN GENERAL.— 

6 ‘‘(1) COMPLIANCE REQUIRED.—An entity that 

7 is a manufacturer, repackager, wholesale distributor, 

8 third-party logistics provider, or dispenser shall com9 ply with the requirements of this section. If an enti10 ty meets the definition of more than one of the enti11 ties referred to in the preceding sentence, such enti12 ty shall comply with all applicable requirements of 

13 this section, but shall not be required to comply with 

14 duplicative requirements. 

15 ‘‘(2) STANDARDS.—The Secretary shall, in con16 sultation with other appropriate Federal officials, 

17 manufacturers, repackagers, wholesale distributors, 

18 third-party logistics providers, and dispensers, estab19 lish, by regulation, standards for the exchange of 

20 transaction history and transaction statement (in 

21 paper or electronic form) for purposes of complying 

22 with this section. The standards established under 

23 this paragraph shall be in accordance with a form 

24 developed by a widely recognized international stand25 ards development organization. In establishing such 


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1 standards, the Secretary shall consider the feasibility 

2 of establishing standardized documentation to be 

3 used by all members of the pharmaceutical distribu4 tion supply chain to convey the transaction history 

5 and transaction statement to the subsequent owner 

6 of a prescription drug product. The Secretary shall 

7 publish such standards not later than 180 days after 

8 the date of the enactment of the Safeguarding 

9 America’s Pharmaceuticals Act of 2013. 

10 ‘‘(3) WAIVERS, EXCEPTIONS, AND EXEMP11 TIONS.—Not later than one year after the date of 

12 the enactment of the Safeguarding America’s Phar13 maceuticals Act of 2013, the Secretary shall promul14 gate a regulation to— 

15 ‘‘(A) establish a process by which the Sec16 retary may grant, at the request of an author17 ized manufacturer, repackager, wholesale dis18 tributor, or dispenser, a waiver from any of the 

19 requirements of this section— 

20 ‘‘(i) if the Secretary determines that 

21 such requirements would result in an 

22 undue economic hardship; or 

23 ‘‘(ii) for emergency medical reasons, 

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1 laration pursuant to section 319 of the 

2 Public Health Service Act; 

3 ‘‘(B) establish a process, with respect to 

4 the prescription drug product identifier require5 ment under paragraph (2) of subsections (b), 

6 (c), (d), and (e) through which— 

7 ‘‘(i) a manufacturer or repackager 

8 may request a waiver with respect to pre9 scription drug products that are packaged 

10 in a container too small or otherwise un11 able to accommodate a label with sufficient 

12 space to bear the information required for 

13 compliance with such requirement; and 

14 ‘‘(ii) the Secretary determines whether 

15 to waive such requirement; and 

16 ‘‘(C) establish a process by which the Sec17 retary may add the prescription drug products 

18 or transactions that are exempt from the re19 quirements of this section. 

20 ‘‘(4) GRANDFATHERED PERSONS AND PRE21 SCRIPTION DRUG PRODUCTS.— 

22 ‘‘(A) IN GENERAL.—Not later than one 

23 year after the date of the enactment of the 

24 Safeguarding America’s Pharmaceuticals Act of 

25 2013, the Secretary shall specify, by regulation, 


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1 whether and under what circumstances the pre2 scription drug product identifier requirement 

3 under paragraph (2) of subsections (b), (c), (d), 

4 and (e) shall apply to a prescription drug prod5 uct that is in the supply chain or in a manufac6 turer’s inventory on the date of the enactment 

7 of the Safeguarding America’s Pharmaceuticals 

8 Act of 2013. 

9 ‘‘(B) THIRD-PARTY LOGISTICS PROVIDER

10 LICENSES.—Until the date that is 1 year after 

11 the effective date of the third-party logistics 

12 provider licensing requirements under section 

13 584, a third-party logistics provider shall be 

14 considered ‘licensed’ under section 581(6)(B) 

15 unless the Secretary has made a finding that 

16 the third-party logistics provider does not utilize 

17 good handling and distribution practices and 

18 publishes notice thereof. 

19 ‘‘(C) LABEL CHANGES.—Changes made to 

20 package labels solely to incorporate the pre21 scription drug product identifier may be sub22 mitted to the Secretary in the annual report of 

23 an establishment, in accordance with section 

24 314.70(d) of chapter 21, Code of Federal Regu25 lations (or any successor regulation). 


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1 ‘‘(b) MANUFACTURER REQUIREMENTS.— 

2 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRAC3 ING.— 

4 ‘‘(A) IN GENERAL.—Beginning not later 

5 than January 1, 2015, a manufacturer shall— 

6 ‘‘(i) prior to, or at the time of, each 

7 transaction in which such manufacturer 

8 transfers ownership of a prescription drug 

9 product— 

10 ‘‘(I) until the date than is 5 

11 years after the date of the enactment 

12 of the Safeguarding America’s Phar13 maceuticals Act of 2013, provide the 

14 subsequent owner with the transaction 

15 history and a transaction statement in 

16 a single document in paper or elec17 tronic form; and 

18 ‘‘(II) on or after such date, pro19 vide the subsequent owner with the 

20 transaction history and a transaction 

21 statement in electronic form; and 

22 ‘‘(ii) maintain the transaction infor23 mation for each such transaction for not 

24 less than 3 years after the date of the 

25 transaction. 


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1 ‘‘(B) REQUESTS FOR INFORMATION.— 

2 Upon a request by the Secretary or other ap3 propriate Federal or State official, in the event 

4 of a recall or for the purpose of investigating a 

5 suspect prescription drug product or an illegit6 imate prescription drug product, a manufac7 turer shall, not later than 2 business days after 

8 receiving the request or in such reasonable time 

9 as determined by the Secretary, provide to the 

10 Secretary or other official, the applicable trans11 action history and transaction statement for the 

12 prescription drug product. 

13 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI14 FIER.—Beginning not later than 5 years after the 

15 date of the enactment of the Safeguarding America’s 

16 Pharmaceuticals Act of 2013, a manufacturer shall 

17 affix or imprint a prescription drug product identi18 fier on each package and homogenous case of a pre19 scription drug product intended to be introduced in 

20 a transaction. Such manufacturer shall maintain the 

21 information in the prescription drug product identi22 fier for such prescription drug product for not less 

23 than 3 years after the date of the transaction. 

24 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Be25 ginning not later than January 1, 2015, a manufacVerDate Mar 15 2010 00:07 Jun 05, 2013 Jkt 029200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.RFS H1919

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1 turer shall ensure that each of its trading partners 

2 is authorized. 

3 ‘‘(4) LIST OF AUTHORIZED DISTRIBUTORS OF

4 RECORD.—Beginning not later than January 1, 

5 2015, each manufacturer of a prescription drug 

6 shall— 

7 ‘‘(A) maintain a list of the authorized dis8 tributors of record of such drug at the cor9 porate offices of such manufacturer; 

10 ‘‘(B) make such list publicly available, in11 cluding placement on the Internet Website of 

12 such manufacturer; and 

13 ‘‘(C) update such list not less than once 

14 per quarter. 

15 ‘‘(5) VERIFICATION.—Beginning not later than 

16 January 1, 2015, a manufacturer shall implement 

17 systems and processes to enable the manufacturer to 

18 comply with the following requirements: 

19 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD20 UCT.— 

21 ‘‘(i) IN GENERAL.—Upon making a 

22 determination that a prescription drug 

23 product in the possession or control of the 

24 manufacturer is a suspect prescription 

25 drug product, or upon receiving a request 


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1 for verification from the Secretary that a 

2 prescription drug product within the pos3 session or control of a manufacturer is a 

4 suspect prescription drug product, a manu5 facturer shall promptly conduct an inves6 tigation in coordination with trading part7 ners, as applicable, to determine whether 

8 the prescription drug product is an illegit9 imate prescription drug product. Beginning 

10 not later than 5 years after the date of the 

11 enactment of the Safeguarding America’s 

12 Pharmaceuticals Act of 2013, such inves13 tigation shall include— 

14 ‘‘(I) verifying the prescription 

15 drug product at the package level; 

16 ‘‘(II) validating any applicable 

17 transaction history in the possession 

18 of the manufacturer; and 

19 ‘‘(III) otherwise investigating to 

20 determine whether the prescription 

21 drug product is an illegitimate pre22 scription drug product. 

23 ‘‘(ii) CLEARED PRESCRIPTION DRUG

24 PRODUCT.—If the manufacturer deter25 mines that a suspect prescription drug 


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1 product is not an illegitimate prescription 

2 drug product, the manufacturer shall 

3 promptly notify the Secretary of such de4 termination and such prescription drug 

5 product may be further distributed. 

6 ‘‘(iii) RECORDS.—A manufacturer 

7 shall keep records of its investigation of a 

8 suspect prescription drug product for not 

9 less than 3 years after the conclusion of 

10 the investigation. 

11 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

12 PRODUCT.— 

13 ‘‘(i) IN GENERAL.—Upon determining 

14 that a prescription drug product in the 

15 possession or control of a manufacturer is 

16 an illegitimate prescription drug product, 

17 the manufacturer shall— 

18 ‘‘(I) quarantine such prescription 

19 drug product from prescription drug 

20 product intended for distribution; and 

21 ‘‘(II) provide for the disposition 

22 of the illegitimate prescription drug 

23 product. 

24 ‘‘(ii) TRADING PARTNER.—Upon de25 termining that a prescription drug product 


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1 in the possession or control of a trading 

2 partner is an illegitimate prescription drug 

3 product, the manufacturer shall take rea4 sonable steps to assist a trading partner to 

5 provide for the disposition of the illegit6 imate prescription drug product. 

7 ‘‘(iii) MAKING A NOTIFICATION.— 

8 Upon determining that a prescription drug 

9 product in the possession or control of the 

10 manufacturer is an illegitimate prescrip11 tion drug product, the manufacturer shall 

12 notify the Secretary of such determination 

13 not later than 24 hours after making such 

14 determination. The Secretary shall deter15 mine whether additional trading partner 

16 notification is appropriate. 

17 ‘‘(iv) RESPONDING TO A NOTIFICA18 TION.—Upon the receipt of a notification 

19 from the Secretary that a determination 

20 has been made that a prescription drug 

21 product is an illegitimate prescription drug 

22 product, a manufacturer shall— 

23 ‘‘(I) identify all illegitimate pre24 scription drug products that are sub25 ject to such notification and in the 


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1 possession or control of the manufac2 turer, including any prescription drug 

3 product that is subsequently received; 

4 and 

5 ‘‘(II) perform the activities de6 scribed in clause (i). 

7 ‘‘(v) RECORDS.—A manufacturer shall 

8 keep records of the disposition of an illegit9 imate prescription drug product for not 

10 less than 3 years after the conclusion of 

11 the disposition. 

12 ‘‘(C) ELECTRONIC DATABASE.—A manu13 facturer may satisfy the requirements of this 

14 paragraph through the use of a secure elec15 tronic database developed and operated by the 

16 manufacturer or another entity. The owner of 

17 such database shall establish the requirements 

18 and processes to respond to requests and may 

19 provide for data access to other members of the 

20 pharmaceutical distribution supply chain, as ap21 propriate. The development and operation of 

22 such a database shall not relieve a manufac23 turer of the requirement under this paragraph 

24 to respond to a verification request submitted 


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1 by means other than a secure electronic data2 base. 

3 ‘‘(D) RETURNED PRESCRIPTION DRUG

4 PRODUCT.—Beginning not later than 5 years 

5 after the date of the enactment of the Safe6 guarding America’s Pharmaceuticals Act of 

7 2013, upon receipt of a returned prescription 

8 drug product that the manufacturer intends to 

9 further distribute, before further distributing 

10 such prescription drug product, the manufac11 turer shall— 

12 ‘‘(i) verify the prescription drug prod13 uct identifier for each sealed homogeneous 

14 case of such prescription drug product; or 

15 ‘‘(ii) if such prescription drug product 

16 is not in a sealed homogeneous case, verify 

17 the prescription drug product identifier on 

18 each package. 

19 ‘‘(c) WHOLESALE DISTRIBUTOR REQUIREMENTS.— 

20 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRAC21 ING.— 

22 ‘‘(A) IN GENERAL.—Beginning not later 

23 than April 1, 2015, a wholesale distributor 

24 shall— 


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1 ‘‘(i) not accept ownership of a pre2 scription drug product unless the previous 

3 owner prior to, or at the time of, the trans4 action provides the applicable transaction 

5 history and a transaction statement for the 

6 prescription drug product; 

7 ‘‘(ii) subject to clause (iv), prior to, or 

8 at the time of, each transaction in which 

9 the wholesale distributor transfers owner10 ship of a prescription drug product— 

11 ‘‘(I) in the case that the whole12 sale distributor purchased the pre13 scription drug product directly from 

14 the manufacturer, the exclusive dis15 tributor of the manufacturer, or a re16 packager that purchased directly from 

17 the manufacturer, provide the subse18 quent owner with transaction history 

19 and a transaction statement for the 

20 prescription drug product— 

21 ‘‘(aa) if the subsequent 

22 owner is a dispenser, on a single 

23 document in paper or electronic 

24 form; or 


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1 ‘‘(bb) if the subsequent 

2 owner is a wholesale distributor, 

3 through any combination of self4 generated paper, electronic data, 

5 or manufacturer-provided infor6 mation on the product package; 

7 ‘‘(II) in the case that the whole8 sale distributor did not purchase the 

9 prescription drug product as described 

10 in subclause (I)— 

11 ‘‘(aa) provide the subsequent 

12 owner with the transaction his13 tory and a transaction statement 

14 beginning with the wholesale dis15 tributor that did so purchase the 

16 prescription drug product in 

17 paper or electronic form; or 

18 ‘‘(bb) pursuant to a written 

19 agreement between the wholesale 

20 distributor and a dispenser, 

21 maintain the transaction history 

22 and transaction statement on be23 half of the dispenser and if re24 quested by the dispenser, provide 

25 the transaction history and 


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1 transaction statement to the dis2 penser in paper or electronic 

3 form in a timely manner so as to 

4 permit the dispenser to comply 

5 with requests pursuant to sub6 section (d)(1)(D); 

7 ‘‘(iii) maintain the transaction infor8 mation for each transaction described in 

9 clauses (i) and (ii) for not less than 3 

10 years after the transaction; and 

11 ‘‘(iv) on or after the date that is 5 

12 years after the date of the enactment of 

13 the Safeguarding America’s Pharma14 ceuticals Act of 2013, provide the trans15 action history and transaction statement in 

16 electronic form. 

17 ‘‘(B) INCLUSION OF LOT NUMBER IN

18 TRANSACTION HISTORY.—Until the date that is 

19 5 years after the date of the enactment of the 

20 Safeguarding America’s Pharmaceuticals Act of 

21 2013, the transaction history provided by a 

22 wholesale distributer under this paragraph shall 

23 not be required to include the lot number of the 

24 product or the initial date of the transaction 

25 from the manufacturer (as such terms are used 


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1 in subparagraphs (F) and (G) of section 

2 581(23)). 

3 ‘‘(C) RETURNS EXCEPTION.— 

4 ‘‘(i) SALEABLE RETURNS.—Notwith5 standing subparagraph (A), a wholesale 

6 distributor may— 

7 ‘‘(I) accept returned prescription 

8 drug product without a transaction 

9 history from a dispenser or repack10 ager; and 

11 ‘‘(II) distribute such returned 

12 prescription drug product with a 

13 transaction history that begins with 

14 the wholesale distributor that so ac15 cepted the returned product. 

16 ‘‘(ii) NONSALEABLE RETURNS.—A 

17 wholesale distributor may return a non18 saleable prescription drug to the manufac19 turer or repackager, to the wholesale dis20 tributor from whom such prescription drug 

21 was purchased, or to a person acting on 

22 behalf of such a person, including a re23 turns processor, without providing the in24 formation required under subparagraph 

25 (A). 


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1 ‘‘(D) REQUESTS FOR INFORMATION.— 

2 Upon a request by the Secretary or other ap3 propriate Federal or State official, in the event 

4 of a recall or for the purpose of investigating a 

5 suspect prescription drug product or an illegit6 imate prescription drug product a wholesale dis7 tributor shall, not later than 2 business days 

8 after receiving the request or in such other rea9 sonable time as determined by the Secretary, 

10 provide the applicable transaction history and 

11 transaction statements for the prescription drug 

12 product. 

13 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI14 FIER.—Beginning not later than 7 years after the 

15 date of the enactment of the Safeguarding America’s 

16 Pharmaceuticals Act of 2013, a wholesale distributor 

17 may engage in transactions involving a prescription 

18 drug product only if such prescription drug product 

19 is encoded with a prescription drug product identi20 fier, except as provided in subsection (a)(4). 

21 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Be22 ginning not later than January 1, 2015, a wholesale 

23 distributor shall ensure that each of its trading part24 ners is authorized. 


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1 ‘‘(4) VERIFICATION.—Beginning not later than 

2 April 1, 2015, a wholesale distributor shall imple3 ment systems to enable the wholesale distributor to 

4 comply with the following requirements: 

5 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD6 UCT.— 

7 ‘‘(i) IN GENERAL.—Upon making a 

8 determination that a prescription drug 

9 product in the possession or control of the 

10 wholesale distributor is a suspect prescrip11 tion drug product, or upon receiving a re12 quest for verification from the Secretary 

13 that a prescription drug product within the 

14 possession or control of a wholesale dis15 tributor is a suspect prescription drug 

16 product, a wholesale distributor shall 

17 promptly conduct an investigation to deter18 mine whether the prescription drug prod19 uct is an illegitimate prescription drug 

20 product. Beginning not later than 7 years 

21 after the date of the enactment of the 

22 Safeguarding America’s Pharmaceuticals 

23 Act of 2013, such investigation shall in24 clude— 


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HR 1919 RFS

1 ‘‘(I) verifying a package of the 

2 prescription drug product; 

3 ‘‘(II) validating any applicable 

4 transaction history in the possession 

5 of the wholesale distributor; and 

6 ‘‘(III) otherwise investigating to 

7 determine whether the prescription 

8 drug product is an illegitimate pre9 scription drug product. 

10 ‘‘(ii) CLEARED PRESCRIPTION DRUG

11 PRODUCT.—If the wholesale distributor de12 termines that a suspect prescription drug 

13 product is not an illegitimate prescription 

14 drug product, the wholesale distributor 

15 shall promptly notify the Secretary of such 

16 determination and such prescription drug 

17 product may be further distributed. 

18 ‘‘(iii) RECORDS.—A wholesale dis19 tributor shall keep records of its investiga20 tion of a suspect prescription drug product 

21 for not less than 3 years after the conclu22 sion of the investigation. 

23 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

24 PRODUCT.— 


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1 ‘‘(i) IN GENERAL.—Upon receiving 

2 notice that a manufacturer of a prescrip3 tion drug product has determined that a 

4 prescription drug product in the possession 

5 or control of a wholesale distributor is an 

6 illegitimate prescription drug product, the 

7 wholesale distributor shall— 

8 ‘‘(I) quarantine such prescription 

9 drug product within the possession or 

10 control of the wholesale distributor 

11 from prescription drug product in12 tended for distribution; and 

13 ‘‘(II) provide for the disposition 

14 of the illegitimate prescription drug 

15 product within the possession or con16 trol of the wholesale distributor. 

17 ‘‘(ii) TRADING PARTNER.—Upon de18 termining that a prescription drug product 

19 in the possession or control of a trading 

20 partner is an illegitimate prescription drug 

21 product, the wholesale distributor shall 

22 take reasonable steps to assist a trading 

23 partner to provide for the disposition of 

24 the illegitimate prescription drug product. 


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1 ‘‘(iii) MAKING A NOTIFICATION.— 

2 Upon determining that a prescription drug 

3 product in the possession or control of the 

4 wholesale distributor is an illegitimate pre5 scription drug product, the wholesale dis6 tributor shall notify the Secretary of such 

7 determination not later than 24 hours 

8 after making such determination. The Sec9 retary shall determine whether additional 

10 trading partner notification is appropriate. 

11 ‘‘(iv) RESPONDING TO A NOTIFICA12 TION.—Upon the receipt of a notification 

13 from the Secretary that a determination 

14 has been made that a prescription drug 

15 product is an illegitimate prescription drug 

16 product, a wholesale distributor shall— 

17 ‘‘(I) identify all illegitimate pre18 scription drug products subject to 

19 such notification that are in the pos20 session or control of the wholesale dis21 tributor, including any such prescrip22 tion drug product that is subsequently 

23 received; and 

24 ‘‘(II) perform the activities de25 scribed in clause (i). 


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1 ‘‘(v) RECORDS.—A wholesale dis2 tributor shall keep records of the disposi3 tion of an illegitimate prescription drug 

4 product for not less than 3 years after the 

5 conclusion of the disposition. 

6 ‘‘(C) ELECTRONIC DATABASE.—A whole7 sale distributor may satisfy the requirements of 

8 this paragraph through the use of a secure elec9 tronic database developed and operated by the 

10 manufacturer or another entity. The owner of 

11 such database shall establish the requirements 

12 and processes to respond to requests and may 

13 provide for data access to other members of the 

14 pharmaceutical distribution supply chain, as ap15 propriate. The development and operation of 

16 such a database shall not relieve a wholesale 

17 distributor of the requirement under this para18 graph to respond to a verification request sub19 mitted by means other than a secure electronic 

20 database. 

21 ‘‘(D) RETURNED PRESCRIPTION DRUG

22 PRODUCT.—Beginning not later than 7 years 

23 after the date of the enactment of the Safe24 guarding America’s Pharmaceuticals Act of 

25 2013, upon receipt of a returned prescription 


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1 drug product that the wholesale distributor in2 tends to further distribute, before further dis3 tributing such prescription drug product, the 

4 wholesale distributor shall— 

5 ‘‘(i) verify the prescription drug prod6 uct identifier for each sealed homogeneous 

7 case of such prescription drug product; or 

8 ‘‘(ii) if such prescription drug product 

9 is not in a sealed homogeneous case, verify 

10 the prescription drug product identifier on 

11 each package. 

12 ‘‘(d) DISPENSER REQUIREMENTS.— 

13 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRAC14 ING.— 

15 ‘‘(A) IN GENERAL.—Beginning not later 

16 than July 1, 2015, a dispenser— 

17 ‘‘(i) shall not accept ownership of a 

18 prescription drug product, unless the pre19 vious owner prior to, or at the time of, the 

20 transaction, provides transaction history 

21 and a transaction statement; 

22 ‘‘(ii) prior to, or at the time of, each 

23 transaction in which the dispenser trans24 fers ownership of a prescription drug prod25 uct (but not including dispensing to a paVerDate Mar 15 2010 00:07 Jun 05, 2013 Jkt 029200 PO 00000 Frm 00043 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.RFS H1919

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1 tient or returns) shall provide the subse2 quent owner with transaction history and a 

3 transaction statement for the prescription 

4 drug product, except that the requirements 

5 of this clause shall not apply to sales by a 

6 dispenser to another dispenser to fulfill a 

7 specific patient need; and 

8 ‘‘(iii) shall maintain transaction infor9 mation for a period of not less than 3 

10 years after the date of the transaction. 

11 ‘‘(B) AGREEMENTS WITH THIRD PAR12 TIES.—A dispenser may enter into a written 

13 agreement with a third party, including an au14 thorized wholesale distributor, under which the 

15 third party confidentially maintains the trans16 action information required to be maintained 

17 under this subsection on behalf of the dis18 penser. If a dispenser enters into such an 

19 agreement, the dispenser shall maintain a copy 

20 of the written agreement. 

21 ‘‘(C) RETURNS EXCEPTION.— 

22 ‘‘(i) SALEABLE RETURNS.—Notwith23 standing subparagraph (A)(ii), a dispenser 

24 may return prescription drug product to 

25 the trading partner from which the disVerDate Mar 15 2010 00:07 Jun 05, 2013 Jkt 029200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.RFS H1919

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1 penser obtained the prescription drug 

2 product without providing the information 

3 required under such subparagraph. 

4 ‘‘(ii) NONSALEABLE RETURNS.—Not5 withstanding subparagraph (A)(ii), a dis6 penser may return a nonsaleable prescrip7 tion drug to the manufacturer or repack8 ager, to the wholesale distributor from 

9 whom such prescription drug was pur10 chased, to a returns processor, or to a per11 son acting on behalf of such persons with12 out providing the information required 

13 under such subparagraph. 

14 ‘‘(D) REQUESTS FOR INFORMATION.— 

15 Upon a request by the Secretary or other ap16 propriate Federal or State official, in the event 

17 of a recall or for the purpose of investigating a 

18 suspect prescription drug product or an illegit19 imate prescription drug product— 

20 ‘‘(i) a dispenser shall not later than 2 

21 business days after receiving the request or 

22 in another such reasonable time as deter23 mined by the Secretary, provide the appli24 cable transaction history and transaction 


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1 statement which the dispenser received 

2 from the previous owner; 

3 ‘‘(ii) the information provided by the 

4 dispenser under clause (i) is not required 

5 to include the lot number of the product, 

6 the initial date of the transaction, or the 

7 initial date of the shipment from the man8 ufacturer unless such information was pro9 vided electronically by the previous owner, 

10 manufacturer, or wholesale distributor to 

11 the dispenser; and 

12 ‘‘(iii) a dispenser may respond to the 

13 request by providing the paper documenta14 tion received from the previous owner or 

15 by providing electronic information. 

16 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI17 FIER.—Beginning not later than 8 years after the 

18 date of the enactment of the Safeguarding America’s 

19 Pharmaceuticals Act of 2013, a dispenser may en20 gage in transactions involving a prescription drug 

21 product only if such prescription drug product is en22 coded with a prescription drug product identifier, ex23 cept as provided in subsection (a)(4). 

24 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Be25 ginning not later than January 1, 2015, a dispenser 


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1 shall ensure that each of its trading partners is au2 thorized. 

3 ‘‘(4) VERIFICATION.—Beginning not later than 

4 January 1, 2015, a dispenser shall implement sys5 tems to enable the dispenser to comply with the fol6 lowing requirements: 

7 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD8 UCT.— 

9 ‘‘(i) IN GENERAL.—Upon making a 

10 determination that a prescription drug 

11 product in the possession or control of the 

12 dispenser is a suspect prescription drug 

13 product, or upon receiving a request for 

14 verification from the Secretary that a pre15 scription drug product within the posses16 sion or control of a dispenser is a suspect 

17 prescription drug product, a dispenser 

18 shall promptly conduct an investigation to 

19 determine whether the prescription drug 

20 product is an illegitimate prescription drug 

21 product. Such investigation shall include— 

22 ‘‘(I) verifying whether the lot 

23 number of a suspect prescription drug 

24 product corresponds with the lot numVerDate Mar 15 2010 00:07 Jun 05, 2013 Jkt 029200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.RFS H1919

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1 ber for such prescription drug prod2 uct; 

3 ‘‘(II) beginning 8 years after the 

4 date of the enactment of the Safe5 guarding America’s Pharmaceuticals 

6 Act of 2013, verifying that the prod7 uct identifier of at least 3 packages or 

8 10 percent of such suspect prescrip9 tion drug product, whichever is great10 er, or all packages, if there are fewer 

11 than 3, corresponds with the prescrip12 tion drug product identifier for such 

13 product; 

14 ‘‘(III) validating any applicable 

15 transaction history in the possession 

16 of the dispenser; and 

17 ‘‘(IV) otherwise investigating to 

18 determine whether the prescription 

19 drug product is an illegitimate pre20 scription drug product. 

21 ‘‘(ii) CLEARED PRESCRIPTION DRUG

22 PRODUCT.—If the dispenser makes the de23 termination that a suspect prescription 

24 drug product is not an illegitimate pre25 scription drug product, the dispenser shall 


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1 promptly notify the Secretary of such de2 termination and such prescription drug 

3 product may be further dispensed. 

4 ‘‘(iii) RECORDS.—A dispenser shall 

5 keep records of its investigation of a sus6 pect prescription drug product for not less 

7 than 3 years after the conclusion of the in8 vestigation. 

9 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

10 PRODUCT.— 

11 ‘‘(i) IN GENERAL.—Upon receiving 

12 notice that a manufacturer of a prescrip13 tion drug product has determined that a 

14 prescription drug product in the possession 

15 or control of a dispenser is an illegitimate 

16 prescription drug product, the dispenser 

17 shall— 

18 ‘‘(I) quarantine such prescription 

19 drug product within the possession or 

20 control of the dispenser from prescrip21 tion drug product intended for dis22 tribution; and 

23 ‘‘(II) provide for the disposition 

24 of the illegitimate prescription drug 


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1 product within the possession or con2 trol of the dispenser. 

3 ‘‘(ii) TRADING PARTNERS.—Upon de4 termining that a prescription drug product 

5 in the possession or control of a trading 

6 partner is an illegitimate prescription drug 

7 product, the dispenser shall take reason8 able steps to assist a trading partner to 

9 provide for the disposition of the illegit10 imate prescription drug product. 

11 ‘‘(iii) MAKING A NOTIFICATION.— 

12 Upon determining that a prescription drug 

13 product in the possession or control of the 

14 dispenser is an illegitimate prescription 

15 drug product, the dispenser shall notify the 

16 Secretary of such determination not later 

17 than 24 hours after making such deter18 mination. The Secretary shall determine 

19 whether additional trading partner notifi20 cation is appropriate. 

21 ‘‘(iv) RESPONDING TO A NOTIFICA22 TION.—Upon the receipt of a notification 

23 from the Secretary that a determination 

24 has been made that a prescription drug 


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1 product is an illegitimate prescription drug 

2 product, a dispenser shall— 

3 ‘‘(I) identify all illegitimate pre4 scription drug products that are sub5 ject to such notification and in the 

6 possession or control of the dispenser, 

7 including any such prescription drug 

8 product that is subsequently received; 

9 and 

10 ‘‘(II) perform the activities de11 scribed in clause (i). 

12 ‘‘(v) RECORDS.—A dispenser shall 

13 keep records of the disposition of an illegit14 imate prescription drug product for not 

15 less than 3 years after the conclusion of 

16 the disposition. 

17 ‘‘(C) ELECTRONIC DATABASE.—A dis18 penser may satisfy the requirements of this 

19 paragraph through the use of a secure elec20 tronic database developed and operated by the 

21 manufacturer or another entity. The owner of 

22 such database shall establish the requirements 

23 and processes to enable responding to requests 

24 and may provide for data access to other mem25 bers of the pharmaceutical distribution supply 


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1 chain, as appropriate. The development and op2 eration of such a database shall not relieve a 

3 dispenser of the requirement under this para4 graph to respond to a verification request sub5 mitted by means other than a secure electronic 

6 database. 

7 ‘‘(e) REPACKAGER REQUIREMENTS.— 

8 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRAC9 ING.— 

10 ‘‘(A) IN GENERAL.—Beginning not later 

11 than April 1, 2015, with respect to a prescrip12 tion drug product received by a repackager 

13 from a wholesale distributor, and beginning not 

14 later than January 1, 2015, with respect to any 

15 other prescription drug product, a repackager 

16 shall— 

17 ‘‘(i) not accept ownership of a pre18 scription drug product unless the previous 

19 owner, prior to, or at the time of, the 

20 transaction, provides transaction history 

21 and a transaction statement for the pre22 scription drug product; 

23 ‘‘(ii) prior to, or at the time of, each 

24 transaction in which the repackager trans25 fers ownership of a prescription drug prodVerDate Mar 15 2010 00:07 Jun 05, 2013 Jkt 029200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.RFS H1919

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1 uct, provide the subsequent owner with 

2 transaction history and a transaction state3 ment; 

4 ‘‘(iii) maintain the transaction infor5 mation for each transaction described in 

6 clause (i) or (ii) for not less than 3 years 

7 after the transaction; and 

8 ‘‘(iv) maintain records that allow the 

9 repackager to associate the prescription 

10 drug product identifier the repackager af11 fixes or imprints with the prescription drug 

12 product identifier assigned by the original 

13 manufacturer of the prescription drug 

14 product. 

15 ‘‘(B) RETURNS EXCEPTION.—Notwith16 standing subparagraph (A)(ii), a repackager 

17 may return prescription drug product to the 

18 trading partner from whom the repackager ob19 tained the prescription drug product without 

20 providing the information required under such 

21 subparagraph. 

22 ‘‘(C) REQUESTS FOR INFORMATION.— 

23 Upon a request by the Secretary or other ap24 propriate Federal or State official, in the event 

25 of a recall or for the purpose of investigating a 


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1 suspect prescription drug product or an illegit2 imate prescription drug product, a repackager 

3 shall, not later than 2 business days after re4 ceiving the request or in such other reasonable 

5 time as determined by the Secretary, provide 

6 the applicable transaction history and trans7 action statement for the prescription drug prod8 uct. 

9 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI10 FIER.—Beginning not later than 6 years after the 

11 date of the enactment of the Safeguarding America’s 

12 Pharmaceuticals Act of 2013, a repackager— 

13 ‘‘(A) shall affix or imprint a prescription 

14 drug product identifier to each package and ho15 mogenous case of prescription drug product in16 tended to be introduced in a transaction; 

17 ‘‘(B) shall maintain the prescription drug 

18 product identifier for such prescription drug 

19 product for not less than 3 years after the date 

20 of the transaction; and 

21 ‘‘(C) may engage in transactions involving 

22 a prescription drug product only if such pre23 scription drug product is encoded with a pre24 scription drug product identifier except as pro25 vided in subsection (a)(4). 


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1 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Be2 ginning on January 1, 2015, a repackager shall en3 sure that each of its trading partners is authorized. 

4 ‘‘(4) VERIFICATION.—Beginning not later than 

5 January 1, 2015, a repackager shall implement sys6 tems to enable the repackager to comply with the 

7 following requirements: 

8 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD9 UCT.— 

10 ‘‘(i) IN GENERAL.—Upon making a 

11 determination that a prescription drug 

12 product in the possession or control of the 

13 repackager is a suspect prescription drug 

14 product, or upon receiving a request for 

15 verification from the Secretary that a pre16 scription drug product within the posses17 sion or control of a repackager is a suspect 

18 prescription drug product, a repackager 

19 shall promptly conduct an investigation to 

20 determine whether the prescription drug 

21 product is an illegitimate prescription drug 

22 product, including— 

23 ‘‘(I) beginning not later than 6 

24 years after the date of the enactment 

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1 maceuticals Act of 2013, verifying the 

2 prescription drug product at the pack3 age level; 

4 ‘‘(II) validating any applicable 

5 transaction information in the posses6 sion of the repackager; and 

7 ‘‘(III) otherwise investigating to 

8 determine whether the prescription 

9 drug product is an illegitimate pre10 scription drug product. 

11 ‘‘(ii) CLEARED PRESCRIPTION DRUG

12 PRODUCT.—If the repackager determines 

13 that a suspect prescription drug product is 

14 not an illegitimate prescription drug prod15 uct, the repackager shall promptly notify 

16 the Secretary of such determination and 

17 such prescription drug product may be fur18 ther distributed. 

19 ‘‘(iii) RECORDS.—A repackager shall 

20 keep records of its investigation of a sus21 pect prescription drug product for not less 

22 than 3 years after the conclusion of the in23 vestigation. 

24 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

25 PRODUCT.— 


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1 ‘‘(i) IN GENERAL.—Upon receiving 

2 notice that a manufacturer of a prescrip3 tion drug product has determined that a 

4 prescription drug product in the possession 

5 or control of a repackager is an illegitimate 

6 prescription drug product, the repackager 

7 shall— 

8 ‘‘(I) quarantine such prescription 

9 drug product within the possession or 

10 control of the repackager from pre11 scription drug product intended for 

12 distribution; and 

13 ‘‘(II) provide for the disposition 

14 of the illegitimate prescription drug 

15 product within the possession or con16 trol of the repackager. 

17 ‘‘(ii) TRADING PARTNER.—Upon de18 termining that a prescription drug product 

19 in the possession or control of a trading 

20 partner is an illegitimate prescription drug 

21 product, the repackagers shall take reason22 able steps to assist the trading partner to 

23 provide for the disposition of the illegit24 imate prescription drug product. 


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1 ‘‘(iii) MAKING A NOTIFICATION.— 

2 Upon determining that a prescription drug 

3 product in the possession or control of the 

4 repackager is an illegitimate prescription 

5 drug product, the repackager shall notify 

6 the Secretary of such determination not 

7 later than 24 hours after making such de8 termination. The Secretary shall determine 

9 whether additional trading partner notifi10 cation is appropriate. 

11 ‘‘(iv) RESPONDING TO A NOTIFICA12 TION.—Upon the receipt of a notification 

13 from the Secretary that a determination 

14 has been made that a prescription drug 

15 product is an illegitimate prescription drug 

16 product, a repackager shall— 

17 ‘‘(I) identify all illegitimate pre18 scription drug products that are sub19 ject to such notification and in the 

20 possession or control of the repack21 ager, including any such prescription 

22 drug product that is subsequently re23 ceived; and 

24 ‘‘(II) perform the activities de25 scribed in clause (i). 


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1 ‘‘(v) RECORDS.—A repackager shall 

2 keep records of the disposition of an illegit3 imate prescription drug product for not 

4 less than 3 years after the conclusion of 

5 the disposition. 

6 ‘‘(C) ELECTRONIC DATABASE.—A repack7 ager may satisfy the requirements of this para8 graph through the use of a secure electronic 

9 database developed and operated by the manu10 facturer or another entity. The owner of such 

11 database shall establish the requirements and 

12 processes to respond to requests and may pro13 vide for data access to other members of the 

14 pharmaceutical distribution supply chain, as ap15 propriate. The development and operation of 

16 such a database shall not relieve a repackager 

17 of the requirement under this paragraph to re18 spond to a verification request submitted by 

19 means other than a secure electronic database. 

20 ‘‘(D) RETURNED PRESCRIPTION DRUG

21 PRODUCT.—Beginning not later than 6 years 

22 after the date of the enactment of the Safe23 guarding America’s Pharmaceuticals Act of 

24 2013, upon receipt of a returned prescription 

25 drug product that the repackager intends to 


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1 further distribute, before further distributing 

2 such prescription drug product, the repackager 

3 shall— 

4 ‘‘(i) verify the prescription drug prod5 uct identifier for each sealed homogeneous 

6 case of such prescription drug product; or 

7 ‘‘(ii) if such prescription drug product 

8 is not in a sealed homogeneous case, verify 

9 the prescription drug product identifier on 

10 each package. 

11 ‘‘(f) THIRD-PARTY LOGISTICS PROVIDER REQUIRE12 MENTS.— 

13 ‘‘(1) AUTHORIZED TRADING PARTNERS.—Be14 ginning on January 1, 2015, a third-party logistics 

15 provider shall ensure that each of its trading part16 ners is authorized. 

17 ‘‘(2) VERIFICATION.—Beginning not later than 

18 January 1, 2015, a third-party logistics provider 

19 shall implement systems to enable the third-party lo20 gistics provider to comply with the following require21 ments: 

22 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD23 UCT.— 

24 ‘‘(i) IN GENERAL.—Upon making a 

25 determination that a prescription drug 


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1 product in the possession or control of a 

2 third-party logistics provider is a suspect 

3 prescription drug product, a third-party lo4 gistics provider shall promptly notify the 

5 owner of such prescription drug product of 

6 the need to conduct an investigation to de7 termine whether the prescription drug 

8 product is an illegitimate prescription drug 

9 product. 

10 ‘‘(ii) CLEARED PRESCRIPTION DRUG

11 PRODUCT.—If the owner of the prescrip12 tion drug product notifies the third-party 

13 logistics provider of the determination that 

14 a suspect prescription drug product is not 

15 an illegitimate prescription drug product, 

16 such prescription drug product may be fur17 ther distributed. 

18 ‘‘(iii) RECORDS.—A third-party logis19 tics provider shall keep records of the ac20 tivities described in clauses (i) and (ii) 

21 with respect to a suspect prescription drug 

22 product for not less than 3 years after the 

23 conclusion of the investigation. 

24 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

25 PRODUCT.— 


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1 ‘‘(i) IN GENERAL.—Upon receiving 

2 notice that a manufacturer of a prescrip3 tion drug product has determined that a 

4 prescription drug product in the possession 

5 or control of a third-party logistics pro6 vider is an illegitimate prescription drug 

7 product, the third-party logistics provider 

8 shall— 

9 ‘‘(I) quarantine such prescription 

10 drug product within the possession or 

11 control of the third-party logistics pro12 vider from prescription drug product 

13 intended for distribution; 

14 ‘‘(II) promptly notify the owner 

15 of such prescription drug product of 

16 the need to provide for the disposition 

17 of such prescription drug product; and 

18 ‘‘(III) promptly transfer posses19 sion of the prescription drug product 

20 to the owner of such prescription drug 

21 product to provide for the disposition 

22 of the prescription drug product. 

23 ‘‘(ii) MAKING A NOTIFICATION.— 

24 Upon determining that a prescription drug 

25 product in the possession or control of the 


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1 third-party logistics provider is an illegit2 imate prescription drug product, the third3 party logistics provider shall notify the 

4 Secretary not later than 24 hours after 

5 making such determination. The Secretary 

6 shall determine whether additional trading 

7 partner notification is appropriate. 

8 ‘‘(iii) RESPONDING TO A NOTIFICA9 TION.—Upon the receipt of a notification 

10 from the Secretary, a third-party logistics 

11 provider shall— 

12 ‘‘(I) identify all illegitimate pre13 scription drug products subject to 

14 such notification that are in the pos15 session or control of the third-party 

16 logistics provider, including any such 

17 prescription drug product that is sub18 sequently received; and 

19 ‘‘(II) perform the activities de20 scribed in clause (i). 

21 ‘‘(iv) RECORDS.—A third-party logis22 tics provider shall keep records of the ac23 tivities described in clauses (i) and (ii) 

24 with respect to an illegitimate prescription 


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1 drug product for not less than 3 years 

2 after the conclusion of the disposition. 

3 ‘‘(g) DROP SHIPMENTS.—This section does not apply 

4 to any entity, notwithstanding its status as a wholesale 

5 distributor or repackager, or other status that is not in6 volved in the physical handling, distribution, or storage of 

7 a prescription drug product. For purposes of this sub8 section, facilitating the distribution of a prescription drug 

9 product by providing various administrative services, in10 cluding processing of orders and payments, shall not, by 

11 itself, be construed as being involved in the handling, dis12 tribution, or storage of a prescription drug product.’’. 

13 SEC. 3. ENHANCED DRUG DISTRIBUTION SECURITY. 

14 (a) PILOT PROJECTS.— 

15 (1) IN GENERAL.—Not later than 2 years after 

16 the date of the enactment of this Act, the Secretary 

17 shall establish one or more pilot projects in coordi18 nation with manufacturers, repackagers, wholesale 

19 distributors, third-party logistics providers, and dis20 pensers to explore and evaluate methods to enhance 

21 the safety and security of the pharmaceutical dis22 tribution supply chain. 

23 (2) CONTENT.— 


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1 (A) IN GENERAL.—The Secretary shall en2 sure that the pilot projects under paragraph (1) 

3 collectively— 

4 (i) reflect the diversity of the pharma5 ceutical distribution supply chain; and 

6 (ii) include participants representative 

7 of every sector within the pharmaceutical 

8 distribution supply chain, including partici9 pants representative of small businesses. 

10 (B) PROJECT DESIGN.—The pilot projects 

11 shall be designed to— 

12 (i) utilize the prescription drug prod13 uct identifier for tracing of a prescription 

14 drug product, which utilization may in15 clude— 

16 (I) verification of the prescription 

17 drug product identifier of a prescrip18 tion drug product; and 

19 (II) the use of aggregation and 

20 inference; 

21 (ii) improve the technical capabilities 

22 of each sector within the pharmaceutical 

23 supply chain to comply with systems and 

24 processes needed to utilize the prescription 


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1 drug product identifiers to enhance tracing 

2 of a prescription drug product; and 

3 (iii) conduct such other activities as 

4 the Secretary determines appropriate to 

5 explore and evaluate methods to enhance 

6 the safety and security of the pharma7 ceutical distribution supply chain. 

8 (b) PUBLIC MEETINGS.— 

9 (1) IN GENERAL.—Not later than 6 months 

10 after the date of the enactment of this Act, and at 

11 least every 6 months thereafter until the submission 

12 of the report required by subsection (e)(2), the Sec13 retary shall hold a public meeting to enhance the 

14 safety and security of the pharmaceutical distribu15 tion supply chain. In conducting such meetings, the 

16 Secretary shall take all measures reasonable and 

17 practicable to ensure the protection of confidential 

18 commercial information and trade secrets. 

19 (2) CONTENT.—In conducting meetings under 

20 this subsection, the Secretary shall seek to address, 

21 in at least one such meeting, each of the following 

22 topics: 

23 (A) Best practices in each of the sectors 

24 within the pharmaceutical distribution supply 

25 chain to implement the requirements of section 


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1 582 of the Federal Food, Drug, and Cosmetic 

2 Act, as added by section 2. 

3 (B) The costs and benefits of implementa4 tion of such section 582, including the impact 

5 on each pharmaceutical distribution supply 

6 chain sector and on public health. 

7 (C) Whether additional electronic 

8 traceability requirements, including tracing of 

9 prescription drug product at the package level, 

10 are feasible, cost effective, overly burdensome 

11 on small businesses, and needed to protect pub12 lic health. 

13 (D) The systems and processes needed to 

14 utilize the prescription drug product identifiers 

15 to enhance tracing of prescription drug product 

16 at the package level, including allowing for 

17 verification, aggregation, and inference by each 

18 sector within the pharmaceutical distribution 

19 supply chain for cases, pallets, totes, and other 

20 containers of aggregated prescription drug 

21 product as necessary. 

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1 ing of prescription drug product at the package 

2 level. 

3 (F) The impact that the requirements, sys4 tems, processes, capabilities, and legal authori5 ties referred to in subparagraphs (C), (D), and 

6 (E) would have on patient safety, the drug sup7 ply, cost and regulatory burden, the timeliness 

8 of patient access to prescription drugs, and 

9 small businesses. 

10 (c) STUDY OF THE PHARMACEUTICAL DISTRIBUTION

11 SUPPLY CHAIN.— 

12 (1) IN GENERAL.—The Comptroller General of 

13 the United States shall conduct a study to examine 

14 implementation of the requirements established 

15 under subchapter H of chapter V of the Federal 

16 Food, Drug, and Cosmetic Act, as added by section 

17 2, in order to inform the regulations promulgated 

18 under this section. 

19 (2) CONSIDERATION.—In conducting the study 

20 under this subsection, the Comptroller General shall 

21 provide for stakeholder input and shall consider the 

22 following: 

23 (A) The implementation of the require24 ments established under such subchapter H 

25 with respect to— 


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1 (i) the ability of the health care sys2 tem collectively to maintain patient access 

3 to medicines; 

4 (ii) the scalability of such require5 ments, including with respect to prescrip6 tion drug product lines; and 

7 (iii) the capability of different sectors 

8 within the pharmaceutical distribution sup9 ply chain, including small businesses, to 

10 affix and utilize the prescription drug 

11 product identifier. 

12 (B) The need for additional legal authori13 ties and activities to address additional gaps in 

14 the pharmaceutical distribution supply chain, if 

15 any, after the implementation of the require16 ments established under such subchapter H 

17 with respect to— 

18 (i) the systems and processes needed 

19 to enhance tracing of prescription drug 

20 product at the package level, including the 

21 use and evaluation of verification, aggrega22 tion, and inference by each sector within 

23 the pharmaceutical distribution supply 

24 chain as necessary; 


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1 (ii) the impact, feasibility, and cost ef2 fectiveness that additional requirements 

3 pursuant to this section would have on 

4 each pharmaceutical distribution supply 

5 chain sector and the public health; and 

6 (iii) the systems and processes needed 

7 to enhance interoperability among trading 

8 partners. 

9 (C) Risks to the security and privacy of 

10 data collected, maintained, or exchanged pursu11 ant to the requirements established under such 

12 subchapter H. 

13 (d) SMALL DISPENSERS.— 

14 (1) IN GENERAL.—Not later than 10 years 

15 after the date of the enactment of this Act, the Sec16 retary shall enter into a contract with a private, 

17 independent consulting firm with relevant expertise 

18 to conduct a technology and software study on the 

19 feasibility of dispensers that have 25 or fewer full20 time employees conducting interoperable, electronic 

21 tracing of prescription drug products at the package 

22 level. 

23 (2) CONDITION.—As a condition of the award 

24 of a contract under paragraph (1), the private inde25 pendent consulting firm awarded such contract shall 


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1 agree to consult with dispensers that have 25 or 

2 fewer full-time employees when conducting the study 

3 under such subparagraph. 

4 (3) STUDY CONTENT.—The study conducted 

5 under paragraph (1) shall assess whether, with re6 spect to conducting interoperable, electronic tracing 

7 of prescription drug products at the package level, 

8 the necessary hardware and software— 

9 (A) is readily accessible to such dispensers; 

10 (B) is not prohibitively expensive to obtain, 

11 install, and maintain for such dispensers; and 

12 (C) can be integrated into business prac13 tices, such as interoperability with wholesale 

14 distributors, for such dispensers. 

15 (4) PUBLICATION.—The Secretary shall pub16 lish— 

17 (A) the statement of work for the study 

18 conducted under paragraph (1) for public com19 ment not later than 30 days before commencing 

20 the study; and 

21 (B) the final version of such study for pub22 lic comment not later than 30 days after such 

23 study is completed. 

24 (5) REPORT TO CONGRESS.—Not later than 30 

25 days after the date on which the study conducted 


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1 under paragraph (1) is completed, the Secretary 

2 shall submit to the Committee on Energy and Com3 merce of the House of Representatives and the Com4 mittee on Health, Education, Labor, and Pensions 

5 of the Senate, a report on the findings of the study 

6 and any recommendations to improve the technology 

7 and software available to small dispensers for pur8 poses of conducting electronic, interoperable tracing 

9 of prescription drug products at the package level. 

10 (6) PUBLIC MEETING.—Not later than 180 

11 days after the date on which the study conducted 

12 under paragraph (1) is completed, the Secretary 

13 shall hold a public meeting at which members of the 

14 public, including stakeholders, may present their 

15 views on the study. 

16 (e) REPORTS.— 

17 (1) GAO REPORT.—Not later than 12 years 

18 after the date of the enactment of this Act, the 

19 Comptroller General shall submit to the Committee 

20 on Energy and Commerce of the House of Rep21 resentatives and the Committee on Health, Edu22 cation, Labor, and Pensions of the Senate a report 

23 on the results of the study conducted under sub24 section (c). 


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1 (2) FDA REPORT.—Not later than 12 years 

2 after the date of the enactment of this Act, the Sec3 retary shall submit to the Committee on Energy and 

4 Commerce of the House of Representatives and the 

5 Committee on Health, Education, Labor, and Pen6 sions of the Senate a report on the results of the 

7 pilot program conducted under subsection (a), tak8 ing into consideration— 

9 (A) the comments received during the pub10 lic meetings conducted under subsection (b); 

11 and 

12 (B) the results of the study conducted, and 

13 the public comments received during the public 

14 meeting held, under subsection (d). 

15 (f) ESTABLISHMENT OF ADDITIONAL REQUIRE16 MENTS.— 

17 (1) IN GENERAL.—Notwithstanding any other 

18 provision of this Act, including the amendments 

19 made by this Act, not earlier than January 1, 2027, 

20 and not later than March 1, 2027, the Secretary 

21 shall issue proposed regulations that establish addi22 tional requirements to prevent a suspect product, il23 legitimate product, or a product that is counterfeit, 

24 stolen, diverted, or otherwise unfit for distribution 


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1 from entering into or being further distributed in 

2 the supply chain, including— 

3 (A) requirements related to the use of 

4 interoperable electronic systems and tech5 nologies for enhanced tracing of prescription 

6 drug product at the package level, which may 

7 include verification of the prescription drug 

8 product identifier of a package of prescription 

9 drug product and enhanced verification of sale10 able returns; 

11 (B) requirements related to the use of ad12 ditional prescription drug product identifiers or 

13 prescription drug product identifier technology 

14 that meet the standards developed under sec15 tion 582(a)(2) of the Federal Food, Drug, and 

16 Cosmetic Act, as added by section 2; 

17 (C) requirements related to the use of ag18 gregation, inference, and other methods, which 

19 shall permit the use of aggregation and infer20 ence for cases, pallets, totes, and other con21 tainers of aggregated prescription drug prod22 ucts by each sector of the pharmaceutical dis23 tribution supply chain, if determined to be nec24 essary components of the systems and tech25 nologies referred to in subparagraph (A); and 


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1 (D) other data transmission and mainte2 nance requirements and interoperability stand3 ards. 

4 (2) FLEXIBILITY.—The requirements described 

5 in paragraph (1) shall provide for flexibility for a 

6 member of the pharmaceutical supply chain, by— 

7 (A) with respect to dispensers, allowing a 

8 dispenser to enter into a written agreement 

9 with a third party, including an authorized 

10 wholesale distributor, under which— 

11 (i) the third party confidentially main12 tains any information required to be main13 tained under such requirements for the 

14 dispenser; and 

15 (ii) the dispenser maintains a copy of 

16 the written agreement and is not relieved 

17 of the other obligations of the dispenser 

18 under such requirements; 

19 (B) establishing a process by which an au20 thorized manufacturer, repackager, wholesale 

21 distributor, or dispenser may request a waiver 

22 from any such requirements if the Secretary de23 termines that such requirements would result in 

24 an undue economic hardship on the manufac25 turer, wholesale distributor, or dispenser; 


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1 (C) not requiring the adoption of specific 

2 business systems by a member of the pharma3 ceutical supply chain for the maintenance and 

4 transmission of prescription drug product trac5 ing data; and 

6 (D) prescribing alternative methods of 

7 compliance for small businesses, as specified in 

8 paragraph (4). 

9 (3) CONSIDERATIONS.—In issuing proposed 

10 regulations under paragraph (1), the Secretary shall 

11 consider— 

12 (A) the results of, and public comments re13 sulting from, the pilot project conducted under 

14 subsection (a); 

15 (B) the public meetings held under sub16 section (b) and public comments from such 

17 meetings; 

18 (C) the studies conducted under sub19 sections (c) and (d); 

20 (D) the reports submitted under subsection 

21 (e); 

22 (E) the public health benefits of such regu23 lations compared with the cost of compliance 

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1 tions, including with respect to entities of vary2 ing sizes and capabilities; and 

3 (F) the diversity of the pharmaceutical dis4 tribution supply chain by providing appropriate 

5 flexibility for each sector in the supply chain, 

6 including small businesses. 

7 (4) SMALL BUSINESS PROTECTION.—The Sec8 retary, taking into consideration the study conducted 

9 under paragraph (d), shall, if the Secretary deter10 mines that the requirements established pursuant to 

11 paragraph (1) would result in an undue economic 

12 hardship on small businesses, provide for alternative 

13 methods of compliance with any such requirement by 

14 small businesses, including— 

15 (A) establishing timelines for such compli16 ance (including compliance by dispensers with 

17 25 or fewer full-time employees) that do not im18 pose undue economic hardship for small busi19 nesses, including dispensers with respect to 

20 which the study concluded has insufficient 

21 hardware and software to conduct interoper22 able, electronic tracing of prescription drug 

23 products at the package level; and 


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1 (B) establishing a process by which a dis2 penser may request a waiver from any such re3 quirement. 

4 (5) REGULATIONS.—In issuing regulations to 

5 carry out this subsection, the Secretary shall— 

6 (A) issue a notice of proposed rulemaking 

7 that includes a copy of the proposed rule; 

8 (B) provide for a period of not less than 

9 60 days for comments on the proposed rule; 

10 and 

11 (C) provide for an effective date of the 

12 final rule that is 2 years after the date on 

13 which such final rule is published. 

14 (6) SUNSET.—The requirements regarding the 

15 provision and receipt of transaction history and 

16 transaction statements under section 582 of the 

17 Federal Food, Drug, and Cosmetic Act, as added by 

18 section 2, shall cease to be effective on the date on 

19 which the regulations issued under this section are 

20 fully implemented. 

21 (g) DEFINITIONS.—In this section: 

22 (1) The terms defined in section 581 of the 

23 Federal Food, Drug, and Cosmetic Act, as added by 

24 section 2, shall have the same meanings in this sec25 tion as such terms are given in such section 581. 


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1 (2) The term ‘‘Secretary’’ means the Secretary 

2 of Health and Human Services, acting through the 

3 Commissioner of Food and Drugs. 

4 SEC. 4. NATIONAL STANDARDS FOR WHOLESALE DISTRIBU5 TORS. 

6 (a) STANDARDS.—Chapter V of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend8 ed— 

9 (1) in section 503 (21 U.S.C. 353), by striking 

10 ‘‘(e)(1)(A)’’ and all that follows through ‘‘(3) For 

11 the purposes of this subsection and subsection (d)— 

12 ’’ and inserting the following: 

13 ‘‘(e) For purposes of subsection (d)—’’; 

14 (2) in section 503(e) (21 U.S.C. 353(e)), by re15 designating subparagraphs (A) and (B) as para16 graphs (1) and (2), respectively; and 

17 (3) in subchapter H, as added by section 2, by 

18 adding at the end the following: 

19 ‘‘SEC. 583. NATIONAL STANDARDS FOR WHOLESALE DIS20 TRIBUTORS. 

21 ‘‘(a) STANDARDS.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall estab23 lish, by regulation, standards for the licensing of 

24 persons that make wholesale distributions. 


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1 ‘‘(2) REQUIREMENTS.—The standards under 

2 paragraph (1) shall, with respect to wholesale dis3 tributions, include requirements for— 

4 ‘‘(A) the storage and handling of drugs 

5 subject to section 503(b)(1), including facility 

6 requirements; 

7 ‘‘(B) the establishment and maintenance of 

8 records of the distributions of such drugs; 

9 ‘‘(C) the furnishing of a bond or other 

10 equivalent means of security in accordance with 

11 paragraph (3); 

12 ‘‘(D) mandatory background checks and 

13 fingerprinting of facility managers or des14 ignated representatives; 

15 ‘‘(E) the establishment and implementa16 tion of qualifications for key personnel; 

17 ‘‘(F) the mandatory physical inspection of 

18 any facility to be used in wholesale distribution 

19 within a reasonable timeframe from the initial 

20 application for licensure of the wholesale dis21 tributor; and 

22 ‘‘(G) in accordance with paragraph (5), the 

23 prohibition of certain persons from engaging in 

24 wholesale distribution. 


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1 ‘‘(3) BOND OR OTHER SECURITY.—The require2 ments under paragraph (2)(C) shall provide for the 

3 following: 

4 ‘‘(A) An applicant that is not a govern5 ment-owned-and-operated wholesale distributor, 

6 for the issuance or renewal of a wholesale dis7 tributor license, shall submit a surety bond of 

8 $100,000 or other equivalent means of security 

9 acceptable to the applicable licensing authority. 

10 ‘‘(B) For purposes of subparagraph (A), 

11 the applicable licensing authority may accept a 

12 surety bond of less than $100,000 if the annual 

13 gross receipts of the previous tax year for the 

14 wholesale distributor is $10,000,000 or less, in 

15 which case the surety bond may not be less 

16 than $25,000. 

17 ‘‘(C) If a wholesale distributor can provide 

18 evidence that it possesses the required bond in 

19 a State, the requirement for a bond in another 

20 State is waived. 

21 ‘‘(4) INSPECTIONS.—To satisfy the inspection 

22 requirement under paragraph (2)(F), the Secretary 

23 may conduct the inspection, or may accept an in24 spection by— 


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1 ‘‘(A) the government of the State in which 

2 the facility is located; or 

3 ‘‘(B) a third-party accreditation or inspec4 tion service approved by the Secretary. 

5 ‘‘(5) PROHIBITED PERSONS.—The requirements 

6 under paragraph (2) shall include requirements to 

7 prohibit a person from receiving or maintaining li8 censure for wholesale distribution if the person— 

9 ‘‘(A) has been convicted of— 

10 ‘‘(i) any felony for conduct relating to 

11 wholesale distribution; 

12 ‘‘(ii) any felony violation of section 

13 301(i) or 301(k); or 

14 ‘‘(iii) any felony violation of section 

15 1365 of title 18, United States Code, relat16 ing to prescription drug product tam17 pering; or 

18 ‘‘(B) has engaged in a pattern of violating 

19 the requirements of this section that presents a 

20 threat of serious adverse health consequences or 

21 death to humans. 

22 ‘‘(b) REPORTING BY LICENSED WHOLESALE DIS23 TRIBUTORS.— 

24 ‘‘(1) ANNUAL REPORT.—Beginning not later 

25 than 1 year after the date of the enactment of this 


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1 section, each person engaged in wholesale distribu2 tion in interstate commerce shall submit on an an3 nual basis, and update as necessary, a report to the 

4 Secretary including— 

5 ‘‘(A) the wholesale distributor’s name; 

6 ‘‘(B) the wholesale distributor’s address; 

7 ‘‘(C) a listing of each State in which the 

8 wholesale distributor is licensed for wholesale 

9 distribution; and 

10 ‘‘(D) any disciplinary actions taken by a 

11 State, the Federal Government, or a foreign 

12 government during the reporting period against 

13 the wholesale distributor. 

14 ‘‘(2) POSTING ON INTERNET.—The Secretary 

15 shall post on the public Internet Website of the 

16 Food and Drug Administration the name of each 

17 wholesale distributor, and the State in which each 

18 such distributor is licensed, based on reports under 

19 paragraph (1). 

20 ‘‘(c) PRESERVATION OF STATE AUTHORITY.—This 

21 subchapter does not prohibit a State from— 

22 ‘‘(1) licensing wholesale distributors for the 

23 conduct of wholesale distribution activities in the 

24 State in accordance with this subchapter; and 


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1 ‘‘(2) collecting fees from wholesale distributors 

2 in connection with such licensing, 

3 so long as the State does not require such licensure to 

4 the extent to which an entity is engaged in third-party 

5 logistics provider activities. 

6 ‘‘(d) DEFINITION.—In this section, the term ‘whole7 sale distribution’ means the distribution of a drug subject 

8 to section 503(b)(1) to a person other than a consumer 

9 or patient, but does not include— 

10 ‘‘(1) intracompany distribution of any drug be11 tween members of an affiliated group (as defined in 

12 section 1504(a) of the Internal Revenue Code of 

13 1986); 

14 ‘‘(2) the distribution of a drug, or an offer to 

15 distribute a drug among hospitals or other health 

16 care entities which are under common control; 

17 ‘‘(3) the distribution of a drug or an offer to 

18 distribute a drug for emergency medical reasons, in19 cluding a public health emergency declaration pursu20 ant to section 319 of the Public Health Service Act, 

21 except that a drug shortage not caused by a public 

22 health emergency shall not constitute such an emer23 gency medical reason; 


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1 ‘‘(4) dispensing of a drug pursuant to a valid 

2 prescription executed in accordance with subsection 

3 503(b)(1); 

4 ‘‘(5) the distribution of minimal quantities of 

5 drug by a licensed retail pharmacy to a licensed 

6 practitioner for office use; 

7 ‘‘(6) the distribution of a drug or an offer to 

8 distribute a drug by a charitable organization to a 

9 nonprofit affiliate of the organization to the extent 

10 otherwise permitted by law; 

11 ‘‘(7) the purchase or other acquisition by a dis12 penser, hospital, or other health care entity of a 

13 drug for use by such dispenser, hospital, or other 

14 health care entity; 

15 ‘‘(8) the distribution of a drug by the manufac16 turer of such drug; 

17 ‘‘(9) the receipt or transfer of a drug by an au18 thorized third-party logistics provider provided that 

19 such third-party logistics provider does not take 

20 ownership of the drug; 

21 ‘‘(10) the transport of a drug by a common car22 rier, provided that the common carrier does not take 

23 ownership of the drug; 

24 ‘‘(11) the distribution of a drug, or an offer to 

25 distribute a drug, by an authorized repackager that 


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1 has taken ownership of the drug and repacked it in 

2 accordance with section 582(e); 

3 ‘‘(12) saleable drug returns when conducted by 

4 a dispenser in accordance with section 203.23 of 

5 title 21, Code of Federal Regulations (or any suc6 cessor regulation); 

7 ‘‘(13) the distribution of a combination pre8 scription drug product described in section 

9 581(20)(B)(xii); 

10 ‘‘(14) the distribution of a medical convenience 

11 kit described in section 581(21)(B)(xiii); 

12 ‘‘(15) the distribution of an intravenous drug 

13 that, by its formulation, is intended for the replen14 ishment of fluids and electrolytes (such as sodium, 

15 chloride, and potassium) or calories (such as dex16 trose and amino acids); 

17 ‘‘(16) the distribution of an intravenous drug 

18 used to maintain the equilibrium of water and min19 erals in the body, such as dialysis solutions; 

20 ‘‘(17) the distribution of a drug that is intended 

21 for irrigation or reconstitution, or sterile water, 

22 whether intended for such purposes or for injection; 

23 ‘‘(18) the distribution of compressed medical 

24 gas (as defined in section 581(21)(C)); 


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1 ‘‘(19) facilitating the distribution of a prescrip2 tion drug product by providing administrative serv3 ices, such as processing of orders and payments, 

4 without physical handling, distribution, or storage of 

5 a prescription drug product; or 

6 ‘‘(20)(A) the distribution of a product by a dis7 penser, or a wholesale distributor acting at the di8 rection of the dispenser, to a repackager registered 

9 under section 510 for the purpose of repackaging 

10 the drug for use by that dispenser or another health 

11 care entity that is under the dispenser’s ownership 

12 or control, so long as the dispenser retains owner13 ship of the prescription drug product; and 

14 ‘‘(B) the saleable or nonsaleable return by such 

15 repackager of such prescription drug product. 

16 ‘‘(e) EFFECTIVE DATE.—The standards required by 

17 subsection (a) shall take effect not later than 2 years after 

18 the date of the enactment of this section. The Secretary 

19 shall issue the regulations required by subsection (a) not 

20 later than 1 year after the date of the enactment of this 

21 Act.’’. 

22 (b) CONFORMING AMENDMENT.—Section 

23 804(a)(5)(A) of the Federal Food, Drug, and Cosmetic 

24 Act (21 U.S.C. 384(a)(5)(A)) is amended by striking 

25 ‘‘503(e)(2)(A)’’ and inserting ‘‘583(a)’’. 


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1 SEC. 5. NATIONAL LICENSURE STANDARDS FOR THIRD2 PARTY LOGISTICS PROVIDERS. 

3 Subchapter H of chapter V of the Federal Food, 

4 Drug, and Cosmetic Act, as amended by section 4, is fur5 ther amended by adding at the end the following: 

6 ‘‘SEC. 584. NATIONAL LICENSURE STANDARDS FOR THIRD7 PARTY LOGISTICS PROVIDERS. 

8 ‘‘(a) LICENSE REQUIREMENT.—No facility may en9 gage in the activities of a third-party logistics provider in 

10 any State unless— 

11 ‘‘(1) the facility is licensed— 

12 ‘‘(A) by the State from which the drug is 

13 distributed by the third-party logistics provider 

14 in accordance with a qualified licensing pro15 gram, if the State has such a program; or 

16 ‘‘(B) by the Secretary under this section, if 

17 the State from which the drug is distributed 

18 does not have such a program; and 

19 ‘‘(2) if the drug is distributed interstate and 

20 the facility is not licensed by the Secretary under 

21 paragraph (1)(B), registers with the State into 

22 which the drug is distributed if such State requires 

23 such registration. 

24 ‘‘(b) REPORTING BY LICENSED THIRD-PARTY LOGIS25 TICS PROVIDERS.— 


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1 ‘‘(1) ANNUAL REPORT.—Beginning not later 

2 than 1 year after the date of the enactment of this 

3 section, each facility engaged in the activities of a 

4 third-party logistics provider shall submit on an an5 nual basis, and update as necessary, a report to the 

6 Secretary including— 

7 ‘‘(A) the facility’s name; 

8 ‘‘(B) the facility’s address; 

9 ‘‘(C) a listing of each jurisdiction (whether 

10 State or Federal) in which the facility is li11 censed for third-party logistics provider activi12 ties; and 

13 ‘‘(D) any disciplinary actions taken by a 

14 State or Federal licensing authority during the 

15 reporting period against the facility. 

16 ‘‘(2) POSTING ON INTERNET.—The Secretary 

17 shall post on the public Internet Website of the 

18 Food and Drug Administration the name of each 

19 third-party logistics provider, and each jurisdiction 

20 (whether State or Federal) in which the provider is 

21 licensed, based on reports under paragraph (1). 

22 ‘‘(c) PRESERVATION OF STATE AUTHORITY.—This 

23 subchapter does not prohibit a State from— 


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1 ‘‘(1) licensing third-party logistic providers for 

2 the conduct of third-party logistics provider activities 

3 in the State in accordance with this subchapter; and 

4 ‘‘(2) collecting fees from third-party logistics 

5 providers in connection with such licensing, 

6 so long as the State does not require such licensure to 

7 the extent to which an entity is engaged in wholesale dis8 tribution. 

9 ‘‘(d) COSTS.— 

10 ‘‘(1) AUTHORIZED LICENSURE FEES.—In the 

11 case of a facility engaging in the activities of a 

12 third-party logistics provider licensed by the Sec13 retary under this section, the Secretary may assess 

14 and collect a reasonable fee in an amount equal to 

15 the costs to the Federal Government of establishing 

16 and administering the licensure program established, 

17 and conducting period inspections, under this sec18 tion. 

19 ‘‘(2) ADJUSTMENT.—The Secretary shall adjust 

20 the amount of the fee under paragraph (1) on an 

21 annual basis, if necessary, to generate an amount of 

22 revenue equal to the costs referred to in such para23 graph. 

24 ‘‘(3) AVAILABILITY.—Fees assessed and col25 lected under this subsection shall be available for obVerDate Mar 15 2010 00:07 Jun 05, 2013 Jkt 029200 PO 00000 Frm 00090 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.RFS H1919

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1 ligation only to the extent and in the amount pro2 vided in advance in appropriations Acts. Such fees 

3 shall remain available until expended. 

4 ‘‘(e) LICENSE REGULATIONS.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall estab6 lish, by regulation, standards, terms, and conditions 

7 for licensing persons to engage in third-party logis8 tics provider activities. 

9 ‘‘(2) CONTENT.—The regulations under para10 graph (1) shall— 

11 ‘‘(A) include standards relating to eligi12 bility for, and revocation and reissuance of, li13 censes; 

14 ‘‘(B) establish a process by which the ap15 plicable licensing authority will, upon request by 

16 a third-party logistics provider that is accred17 ited by a third-party accreditation program ap18 proved by the Secretary, issue a license to the 

19 provider; 

20 ‘‘(C) establish a process by which the Sec21 retary shall issue a license to a third-party lo22 gistics provider if the Secretary is not able to 

23 approve a third-party accreditation program be24 cause no such program meets the Secretary’s 


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1 requirements necessary for approval of such a 

2 third-party accreditation program; 

3 ‘‘(D) require that the third-party logistics 

4 provider comply with storage practices, as de5 termined by the Secretary, at the provider’s fa6 cilities, including— 

7 ‘‘(i) maintaining access to warehouse 

8 space of suitable size to facilitate safe op9 erations, including a suitable area to quar10 antine suspect prescription drug product; 

11 ‘‘(ii) maintaining adequate security; 

12 and 

13 ‘‘(iii) having written policies and pro14 cedures to— 

15 ‘‘(I) address receipt, security, 

16 storage, inventory, shipment, and dis17 tribution of a prescription drug prod18 uct; 

19 ‘‘(II) identify, record, and report 

20 confirmed losses or thefts in the 

21 United States; 

22 ‘‘(III) correct errors and inac23 curacies in inventories; 

24 ‘‘(IV) provide support for manu25 facturer recalls; 


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1 ‘‘(V) prepare for, protect against, 

2 and address any reasonably foresee3 able crisis that affects security or op4 eration at the facility, such as a 

5 strike, fire, or flood; 

6 ‘‘(VI) ensure that any expired 

7 prescription drug product is seg8 regated from other prescription drug 

9 products and returned to the manu10 facturer or repackager or destroyed; 

11 ‘‘(VII) maintain the capability to 

12 electronically trace the receipt and 

13 outbound distribution of a prescrip14 tion drug product, and supplies and 

15 records of inventory; and 

16 ‘‘(VIII) quarantine or destroy a 

17 suspect prescription drug product if 

18 directed to do so by the respective 

19 manufacturer, wholesale distributor, 

20 dispenser, or an authorized govern21 ment agency; 

22 ‘‘(E) provide for periodic inspection, as de23 termined by the Secretary, of such facility ware24 house space to ensure compliance with this sec25 tion; 


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1 ‘‘(F) prohibit a facility from having as a 

2 manager or designated representative anyone 

3 convicted of any felony violation of section 

4 301(i) or 301(k) or any felony violation of sec5 tion 1365 of title 18, United States Code, relat6 ing to prescription drug product tampering; 

7 ‘‘(G) perform mandatory background 

8 checks of the provider’s facility managers or 

9 designated representatives of such managers; 

10 ‘‘(H) require a third-party logistics pro11 vider to provide to the applicable licensing au12 thority, upon the authority’s request, a list of 

13 all prescription drug product manufacturers, 

14 wholesale distributors, and dispensers for whom 

15 the third-party logistics provider provides serv16 ices at the provider’s facilities; and 

17 ‘‘(I) include procedures under which any 

18 third-party logistics provider license— 

19 ‘‘(i) will expire on the date that is 3 

20 years after issuance of the license; and 

21 ‘‘(ii) may be renewed for additional 3- 

22 year periods. 

23 ‘‘(f) VALIDITY OF LICENSE.—A license issued under 

24 this section shall remain valid as long as such third-party 

25 logistics provider remains accredited by the Secretary, 


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1 subject to renewal under subsection (d). If the Secretary 

2 finds that the third-party accreditation program dem3 onstrates that all applicable requirements for licensure 

4 under this section are met, the Secretary shall issue a li5 cense under this section to a third-party logistics provider 

6 receiving accreditation. 

7 ‘‘(g) QUALIFIED LICENSING PROGRAM DEFINED.— 

8 In this section, the term ‘qualified licensing program’ 

9 means a program meeting the requirements of this section 

10 and the regulations thereunder. 

11 ‘‘(h) EFFECTIVE DATE.—The requirements of this 

12 section shall take effect not later than 1 year after the 

13 date of the enactment of this section. The Secretary shall 

14 issue the regulations required by subsection (d) not later 

15 than 180 days after the date of the enactment of this sec16 tion.’’. 

17 SEC. 6. PENALTIES. 

18 (a) PROHIBITED ACTS.—Section 301(t) of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(t)) is 

20 amended by striking ‘‘or the distribution of drugs in viola21 tion of section 503(e) or the failure to otherwise comply 

22 with the requirements of section 503(e)’’ and inserting 

23 ‘‘the failure to comply with any requirement of section 

24 582, engaging in the wholesale distribution of a drug in 

25 violation of section 583 or the failure to otherwise comply 


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1 with the requirements of section 583, or engaging in the 

2 activities of a third-party logistics provider in violation of 

3 section 584 or the failure to otherwise comply with the 

4 requirements of section 584’’. 

5 (b) ENHANCED PENALTY FOR KNOWING UNLI6 CENSED ACTIVITIES.—Section 303(b)(1)(D) of the Fed7 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

8 333(b)(1)(D)) is amended by striking ‘‘503(e)(2)(A)’’ and 

9 inserting ‘‘583 or 584’’. 

10 (c) MISBRANDING.—Section 502 of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend12 ed by adding at the end the following: 

13 ‘‘(bb) If it is a drug and it fails to bear a prescription 

14 drug product identifier as required by section 582.’’. 

15 SEC. 7. UNIFORM NATIONAL POLICY. 

16 Subchapter H of chapter V of the Federal Food, 

17 Drug, and Cosmetic Act, as amended by section 5, is fur18 ther amended by adding at the end the following: 

19 ‘‘SEC. 585. UNIFORM NATIONAL POLICY. 

20 ‘‘(a) PREEMPTION OF STATE PRESCRIPTION DRUG

21 PRODUCT TRACING AND OTHER REQUIREMENTS.—Be22 ginning on the date of the enactment of the Safeguarding 

23 America’s Pharmaceuticals Act of 2013, no State or polit24 ical subdivision of a State may establish or continue in 

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1 tribution system (including any requirements with respect 

2 to paper or electronic pedigrees, track and trace, state3 ments of distribution history, transaction history, or 

4 transaction statements, or verification, investigation, dis5 position, alerts, or recordkeeping relating to the pharma6 ceutical distribution supply chain system) that— 

7 ‘‘(1) are inconsistent with, more stringent than, 

8 or in addition to any requirements applicable under 

9 this Act; or 

10 ‘‘(2) are inconsistent with any applicable waiv11 er, exception, or exemption issued by the Secretary 

12 under section 582(a). 

13 ‘‘(b) STANDARDS OR LICENSURE.— 

14 ‘‘(1) IN GENERAL.—Beginning on the date of 

15 the enactment of Safeguarding America’s Pharma16 ceuticals Act of 2013, no State or political subdivi17 sion of a State may establish or continue any stand18 ards, requirements, or regulations with respect to 

19 wholesale drug distributor or third-party logistics 

20 provider licensure which are inconsistent with, less 

21 stringent than, in addition to, or more stringent 

22 than, the standards and requirements under this 

23 Act. 

24 ‘‘(2) LICENSING FEES.—Paragraph (1) does 

25 not affect the authority of a State to collect fees 


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1 from wholesale drug distributors or third-party logis2 tics providers in connection with State licensing 

3 under section 583 or 584 pursuant to a licensing 

4 program meeting the requirements of such sections. 

5 ‘‘(3) ENFORCEMENT, SUSPENSION, AND REV6 OCATION OF LICENSES.—Notwithstanding paragraph 

7 (1), a State— 

8 ‘‘(A) may take administrative action, in9 cluding fines, to enforce a licensure requirement 

10 promulgated by the State in accordance with 

11 this Act; 

12 ‘‘(B) may provide for the suspension or 

13 revocation of licenses issued by the State for 

14 violations of the laws of such State; 

15 ‘‘(C) upon conviction of a person for a vio16 lation of Federal, State, or local controlled sub17 stance laws or regulations, may provide for 

18 fines, imprisonment, or civil penalties; and 

19 ‘‘(D) may regulate activities of entities li20 censed pursuant to section 583 or 584 in a 

21 manner that is consistent with the provisions of 

22 this subchapter.’’. 

23 SEC. 8. ELECTRONIC LABELING. 

24 (a) IN GENERAL.—Section 502(f) of the Federal 

25 Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is 


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1 amended by adding at the end the following new sentence: 

2 ‘‘Required labeling (other than immediate container or 

3 carton labels) that is intended for use by a physician, a 

4 pharmacist, or another health care professional, and that 

5 provides directions for human use of a drug subject to sec6 tion 503(b)(1), may (except as necessary to mitigate a 

7 safety risk, as specified by the Secretary in regulation) be 

8 made available by electronic means instead of paper form, 

9 provided that such labeling complies with all applicable re10 quirements of law, the manufacturer or distributor, as ap11 plicable, affords health care professionals and authorized 

12 dispensers (as defined in section 581) the opportunity to 

13 request the labeling in paper form, and after such a re14 quest the manufacturer or distributor promptly provides 

15 the requested information without additional cost.’’. 

16 (b) REGULATIONS.—The Secretary of Health and 

17 Human Services shall promulgate regulations imple18 menting the amendment made by subsection (a). 

19 (c) APPLICATION.—The last sentence of section 

20 502(f) of the Federal Food, Drug, and Cosmetic Act (21 

21 U.S.C. 352(f)), as added by subsection (a), shall apply be22 ginning on the earlier of— 

23 (1) the effective date of final regulations pro24 mulgated under subsection (b); or 


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1 (2) the day that is 180 days after the date of 

2 enactment of this Act. 

Passed the House of Representatives June 3, 2013. 

Attest: KAREN L. HAAS, 

Clerk. 


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