I 

113TH CONGRESS 

1ST SESSION H. R. 1919 

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

pharmaceutical distribution supply chain, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 9, 2013 

Mr. LATTA (for himself, Mr. MATHESON, Mr. UPTON, Mr. DINGELL, Mr. CASSIDY, Mrs. BLACKBURN, Mr. MCKINLEY, Mr. ROGERS of Michigan, Mr. 

BURGESS, Mr. SHIMKUS, Mr. GUTHRIE, Mr. JOHNSON of Ohio, and Mr. 

SCHNEIDER) introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

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

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

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

7 this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Pharmaceutical distribution supply chain. 


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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 requirement. 

1 SEC. 2. PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN. 

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

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

4 end the following: 

5 ‘‘Subchapter H—Pharmaceutical Distribution 

6 Supply Chain 

7 ‘‘SEC. 581. DEFINITIONS. 

8 ‘‘In this subchapter: 

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

10 means— 

11 ‘‘(A) in the case of a manufacturer or re12 packager, having a valid registration in accord13 ance with section 510; and 

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

15 third-party logistics provider, or dispenser, li16 censed (as defined in this section). 

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

18 ‘‘(A) subject to subparagraph (B), means a 

19 retail pharmacy, hospital pharmacy, a group of 

20 chain pharmacies under common ownership and 

21 control that do not act as a wholesale dis22 tributor, or any other person authorized by law 


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1 to dispense or administer prescription drugs 

2 and the affiliated warehouses or distribution 

3 centers of such persons under common owner4 ship and control that do not act as a wholesale 

5 distributor; and 

6 ‘‘(B) does not include a person who only 

7 dispenses prescription drug product to be used 

8 in animals in accordance with section 

9 512(a)(5). 

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

11 with respect to a prescription drug product within 

12 the possession and control of an entity— 

13 ‘‘(A) means the removal of such prescrip14 tion drug product, or taking measures to pre15 vent the introduction of such prescription drug 

16 product, from the pharmaceutical distribution 

17 supply chain; and 

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

19 prescription drug product for disposal, or other 

20 appropriate handling and other actions such as 

21 retaining a sample of the prescription drug 

22 product for additional physical examination or 

23 laboratory analysis by a manufacturer or regu24 latory or law enforcement agency. 


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

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

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

4 prescription drug product. 

5 ‘‘(5) ILLEGITIMATE PRESCRIPTION DRUG PROD6 UCT.—The term ‘illegitimate prescription drug prod7 uct’ means a prescription drug product which a 

8 manufacturer has confirmed— 

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

10 ‘‘(B) is intentionally adulterated such that 

11 the prescription drug product would result in 

12 serious adverse health consequences or death to 

13 humans; or 

14 ‘‘(C) is otherwise unfit for distribution 

15 such that the prescription drug product is rea16 sonably likely to cause serious adverse human 

17 health consequences or death. 

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

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

20 having a valid license to make wholesale dis21 tributions consistent with the standards under 

22 section 583; 

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

24 provider, having a valid license to engage in the 


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1 activities of a third-party logistics provider in 

2 accordance with section 584; and 

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

4 valid license to dispense prescription drugs 

5 under State law. 

6 ‘‘(7) MANUFACTURER.—The term ‘manufac7 turer’ means, with respect to a prescription drug 

8 product— 

9 ‘‘(A) a person that holds an application ap10 proved under section 505 or a license issued 

11 under section 351 of the Public Health Service 

12 Act for such prescription drug product, or if 

13 such prescription drug product is not the sub14 ject of an approved application or license, the 

15 person who manufactured the prescription drug 

16 product; 

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

18 described in subparagraph (A) that obtains the 

19 prescription drug product directly from the per20 son described in such subparagraph; or 

21 ‘‘(C) a person that— 

22 ‘‘(i) is a member of an affiliated 

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

24 Internal Revenue Code of 1986) to which 


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1 a person described in subparagraph (A) or 

2 (B) is also a member; and 

3 ‘‘(ii) receives the prescription drug 

4 product directly from a person described in 

5 subparagraph (A) or (B). 

6 ‘‘(8) PACKAGE.— 

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

8 means the smallest individual saleable unit of 

9 prescription drug product for distribution in 

10 interstate commerce by a manufacturer or re11 packager that is intended by the manufacturer 

12 for ultimate sale to the dispenser of such pre13 scription drug product. 

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

15 term ‘individual saleable unit’ means the small16 est container of prescription drug product intro17 duced into interstate commerce by the manufac18 turer or repackager that is intended by the 

19 manufacturer for individual sale to a dispenser. 

20 ‘‘(9) PRESCRIPTION DRUG.—The term ‘pre21 scription drug’ means a drug for human use subject 

22 to section 503(b)(1). 

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

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1 tion to a patient without substantial further manu2 facturing (such as capsules, tablets, and lyophilized 

3 prescription drug products before reconstitution). 

4 ‘‘(11) PRESCRIPTION DRUG PRODUCT IDENTI5 FIER.—The term ‘prescription drug product identi6 fier’ means a standardized graphic that— 

7 ‘‘(A) includes the standardized numerical 

8 identifier, lot number, and expiration date of a 

9 prescription drug product; and 

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

11 on a machine-readable data carrier that con12 forms to the standards developed by a widely 

13 recognized international standards development 

14 organization. 

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

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

17 of preventing distribution or transfer of the product, 

18 in a physically separate area clearly identified for 

19 such use, or through use of other procedures such 

20 as automated designation. 

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

22 means a person who owns or operates an establish23 ment that repacks and relabels a prescription drug 

24 product or package for further sale or distribution. 


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1 ‘‘(14) RETURN.—The term ‘return’ means pro2 viding prescription drug product to the authorized 

3 trading partner or trading partners from which such 

4 prescription drug product was purchased, or to a re5 turns processor for handling of such prescription 

6 drug product. 

7 ‘‘(15) RETURNS PROCESSOR.—The terms ‘re8 turns processor’ mean a person who owns or oper9 ates an establishment that provides for the disposi10 tion of or otherwise processes saleable and nonsale11 able prescription drug product received from an au12 thorized trading partner such that the prescription 

13 drug product may be processed for credit to the pur14 chaser, manufacturer, seller, or disposed of for no 

15 further distribution. 

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

17 ‘specific patient need’— 

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

19 a prescription drug product from one pharmacy 

20 to another, to fill a prescription for an identi21 fied patient; and 

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

23 prescription drug product from one pharmacy 

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1 plenishing stock in anticipation of a potential 

2 need. 

3 ‘‘(17) STANDARDIZED NUMERICAL IDENTI4 FIER.—The term ‘standardized numerical identifier’ 

5 means a set of numbers or characters that— 

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

7 package or homogenous case of the prescription 

8 drug product; and 

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

10 Code that corresponds to the specific prescrip11 tion drug product (including the particular 

12 package configuration) combined with a unique 

13 alphanumeric serial number of up to 20 char14 acters. 

15 ‘‘(18) SUSPECT PRESCRIPTION DRUG PROD16 UCT.—The term ‘suspect prescription drug product’ 

17 means a prescription drug product for which there 

18 is reason to believe that such prescription drug prod19 uct— 

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

21 stolen; 

22 ‘‘(B) is potentially intentionally adulterated 

23 such that the prescription drug product would 

24 result in serious adverse health consequences or 

25 death to humans; or 


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1 ‘‘(C) appears otherwise unfit for distribu2 tion such that the prescription drug product 

3 would result in serious adverse health con4 sequences or death to humans. 

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

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

7 entity that provides or coordinates warehousing, dis8 tribution, or other logistics services of a prescription 

9 drug product in interstate commerce on behalf of a 

10 manufacturer, wholesale distributor, or dispenser of 

11 a prescription drug product, but does not take own12 ership of the prescription drug product, nor have re13 sponsibility to direct the sale or disposition of, the 

14 prescription drug product. 

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

16 partner’ means— 

17 ‘‘(A) a manufacturer, repackager, whole18 sale distributor, or dispenser from whom a 

19 manufacturer, repackager, wholesale dis20 tributor, or dispenser accepts ownership of a 

21 prescription drug product or to whom a manu22 facturer, repackager, wholesale distributor, or 

23 dispenser transfers ownership of a prescription 

24 drug product; or 


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

2 whom a manufacturer, repackager, wholesale 

3 distributor, or dispenser accepts possession of a 

4 prescription drug product or to whom a manu5 facturer, repackager, wholesale distributor, or 

6 dispenser transfers possession of a prescription 

7 drug product. 

8 ‘‘(21) TRANSACTION.— 

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

10 means the transfer in interstate commerce of 

11 prescription drug product between persons in 

12 which a change of ownership occurs. 

13 ‘‘(B) EXEMPTIONS.—The term ‘trans14 action’ does not include— 

15 ‘‘(i) intracompany distribution of any 

16 prescription drug product between mem17 bers of an affiliated group (as defined in 

18 section 1504(a) of the Internal Revenue 

19 Code of 1986); 

20 ‘‘(ii) the distribution of a prescription 

21 drug product among hospitals or other 

22 health care entities that are under common 

23 control; 

24 ‘‘(iii) the distribution of a prescription 

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1 sons including a public health emergency 

2 declaration pursuant to section 319 of the 

3 Public Health Service Act, except that a 

4 drug shortage not caused by a public 

5 health emergency shall not constitute an 

6 emergency medical reason; 

7 ‘‘(iv) the dispensing of a prescription 

8 drug product pursuant to a valid prescrip9 tion executed in accordance with section 

10 503(b)(1); 

11 ‘‘(v) the distribution of prescription 

12 drug product samples by a manufacturer 

13 or a licensed wholesale distributor in ac14 cordance with section 503(d); 

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

16 components intended for transfusion; 

17 ‘‘(vii) the distribution of minimal 

18 quantities of prescription drug product by 

19 a licensed retail pharmacy to a licensed 

20 practitioner for office use; 

21 ‘‘(viii) the distribution of a prescrip22 tion drug product by a charitable organiza23 tion to a nonprofit affiliate of the organiza24 tion to the extent otherwise permitted by 

25 law; 


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1 ‘‘(ix) the distribution of a prescription 

2 drug product pursuant to the sale or merg3 er of a pharmacy or pharmacies or a 

4 wholesale distributor or wholesale distribu5 tors, except that any records required to be 

6 maintained for the prescription drug prod7 uct shall be transferred to the new owner 

8 of the pharmacy or pharmacies or whole9 sale distributor or wholesale distributors; 

10 ‘‘(x) the dispensing of a prescription 

11 drug product approved under section 

12 512(b); 

13 ‘‘(xi) the transfer of prescription drug 

14 products to or from any facility that is li15 censed by the Nuclear Regulatory Commis16 sion or by a State pursuant to an agree17 ment with such Commission under section 

18 274 of the Atomic Energy Act of 1954 (42 

19 U.S.C. 2021); 

20 ‘‘(xii) the distribution of a combina21 tion product that consists of— 

22 ‘‘(I) a product comprised of two 

23 or more components that are each a 

24 drug, biological product, or device and 

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1 erwise combined or mixed and pro2 duced as a single entity; 

3 ‘‘(II) two or more separate prod4 ucts packaged together in a single 

5 package or as a unit and comprised of 

6 a drug and device or a device and bio7 logical product; or 

8 ‘‘(III) two or more finished de9 vices plus one or more drug or biologi10 cal products which are packaged to11 gether in a medical convenience kit 

12 described in clause (xiv); 

13 ‘‘(xiii) the distribution of a medical 

14 convenience kit which is a collection of fin15 ished products (consisting of devices or 

16 drugs) assembled in kit form strictly for 

17 the convenience of the purchaser or user 

18 if— 

19 ‘‘(I) the medical convenience kit 

20 is assembled in an establishment that 

21 is registered with the Food and Drug 

22 Administration as a medical device 

23 manufacturer; 

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1 chased the prescription drug product 

2 directly from the manufacturer or 

3 from a wholesale distributor that pur4 chased the prescription drug product 

5 directly from the manufacturer; 

6 ‘‘(III) the person who manufac7 turers the medical convenience kit 

8 does not alter the primary container 

9 or label of the prescription drug prod10 uct as purchased from the manufac11 turer or wholesale distributor; 

12 ‘‘(IV) the medical convenience kit 

13 does not contain a controlled sub14 stance (as defined in section 102 of 

15 the Controlled Substances Act); and 

16 ‘‘(V) the prescription drug prod17 ucts contained in the medical conven18 ience kit are— 

19 ‘‘(aa) intravenous solutions 

20 intended for the replenishment of 

21 fluids and electrolytes; 

22 ‘‘(bb) drugs intended to 

23 maintain the equilibrium of water 

24 and minerals in the body; 


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1 ‘‘(cc) drugs intended for irri2 gation or reconstitution; 

3 ‘‘(dd) anesthetics; 

4 ‘‘(ee) anticoagulants; 

5 ‘‘(ff) vasopressors; or 

6 ‘‘(gg) sympathicomimetics; 

7 ‘‘(xiv) the distribution of an intra8 venous prescription drug product that, by 

9 its formulation, is intended for the replen10 ishment of fluids and electrolytes (such as 

11 sodium, chloride, and potassium) or cal12 ories (such as dextrose and amino acids); 

13 ‘‘(xv) the distribution of an intra14 venous prescription drug product used to 

15 maintain the equilibrium of water and min16 erals in the body, such as dialysis solu17 tions; 

18 ‘‘(xvi) the distribution of a prescrip19 tion drug product that is intended for irri20 gation or reconstitution, or sterile water, 

21 whether intended for such purposes or for 

22 injection; or 

23 ‘‘(xvii) the distribution of compressed 

24 medical gas. 


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1 ‘‘(C) COMPRESSED MEDICAL GAS.—For 

2 purposes of subparagraph (B)(xviii), the term 

3 ‘compressed medical gas’ means any substance 

4 in its gaseous or cryogenic liquid form that 

5 meets medical purity standards and has appli6 cation in a medical or homecare environment, 

7 including oxygen and nitrous oxide. 

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

9 ‘transaction history’ means a statement that— 

10 ‘‘(A) includes the transaction information 

11 for each transaction conducted with respect to 

12 a prescription drug product beginning with the 

13 manufacturer or initial purchase distributor for 

14 each prior transaction going back to the manu15 facturer of the prescription drug product or to 

16 the initial purchase distributor; and 

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

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

19 ‘transaction information’ means— 

20 ‘‘(A) the proprietary or established name 

21 or names of the prescription drug product; 

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

23 prescription drug product; 

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

25 the prescription drug product; 


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1 ‘‘(D) the container size; 

2 ‘‘(E) the number of containers; 

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

4 drug product; 

5 ‘‘(G) the date of the transaction; 

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

7 person from whom ownership is being trans8 ferred; and 

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

10 person to whom ownership is being transferred. 

11 ‘‘(24) TRANSACTION STATEMENT.—The ‘trans12 action statement’ is a statement, which states that 

13 the manufacturer, repackager, wholesale distributor, 

14 third-party logistics provider, or dispenser transfer15 ring ownership in a transaction— 

16 ‘‘(A) is authorized; 

17 ‘‘(B) received transaction information and 

18 a transaction statement as required under sec19 tion 582 from the prior owner of the prescrip20 tion drug product; 

21 ‘‘(C) did not knowingly and intentionally 

22 ship an illegitimate prescription drug product; 

23 ‘‘(D) did not knowingly and intentionally 

24 provide false transaction information; and 


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1 ‘‘(E) did not knowingly and intentionally 

2 alter the transaction history. 

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

4 ‘verification’ and ‘verify’— 

5 ‘‘(A) mean determining whether the pre6 scription drug product identifier affixed to, or 

7 imprinted upon, a package or homogeneous case 

8 of the prescription drug product corresponds to 

9 the standardized numerical identifier or lot 

10 number, and expiration date assigned to the 

11 prescription drug product by the manufacturer 

12 or the repackager, as applicable; and 

13 ‘‘(B) include making the determination 

14 under subparagraph (A) using human-readable 

15 or machine-readable methods. 

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

17 ‘wholesale distributor’— 

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

19 distribution (as defined in section 583); and 

20 ‘‘(B) excludes— 

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

22 partner of a manufacturer, or a third-party 

23 logistics provider, or a dispenser who does 

24 not engage in such wholesale distribution; 


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1 ‘‘(ii) a repackager engaged in such 

2 wholesale distribution; or 

3 ‘‘(iii) the distribution of prescription 

4 drug product or an offer to distribute pre5 scription drug product by an authorized re6 packager that has taken ownership or pos7 session of the prescription drug product 

8 and repacked the prescription drug prod9 uct in accordance with the requirements of 

10 section 582(e). 

11 ‘‘SEC. 582. REQUIREMENTS. 

12 ‘‘(a) IN GENERAL.— 

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

14 is a manufacturer, repackager, wholesale distributor, 

15 third-party logistics provider, or dispenser shall com16 ply with the requirements of this section. If an enti17 ty meets the definition of more than one of the enti18 ties referred to in the preceding sentence, such enti19 ty shall comply with all applicable requirements of 

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

21 duplicative requirements. 

22 ‘‘(2) STANDARDS.—The Secretary shall, in con23 sultation with other appropriate Federal officials, 

24 manufacturers, repackagers, wholesale distributors, 

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1 lish, by regulation, standards for the exchange of 

2 transaction information for purposes of complying 

3 with this section. The standards established under 

4 this paragraph shall be in accordance with a form 

5 developed by a widely recognized international stand6 ards development organization. In establishing such 

7 standards, the Secretary shall consider the feasibility 

8 of establishing standardized documentation to be 

9 used by all members of the pharmaceutical distribu10 tion supply chain to convey the transaction history 

11 and transaction statement to the subsequent owner 

12 of a prescription drug product. The Secretary shall 

13 publish such standards not later than 180 days after 

14 the date of the enactment of the Safeguarding 

15 America’s Pharmaceuticals Act of 2013. 

16 ‘‘(3) WAIVERS, EXCEPTIONS, AND EXEMP17 TIONS.—Not later than one year after the date of 

18 the enactment of the Safeguarding America’s Phar19 maceuticals Act of 2013, the Secretary shall promul20 gate a regulation to— 

21 ‘‘(A) establish a process by which the Sec22 retary may grant, at the request of an author23 ized manufacturer, repackager, wholesale dis24 tributor, or dispenser, a waiver from any of the 

25 requirements of this section— 


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1 ‘‘(i) if the Secretary determines that 

2 such requirements would result in an 

3 undue economic hardship; or 

4 ‘‘(ii) for emergency medical reasons, 

5 including a public health emergency dec6 laration pursuant to section 319 of the 

7 Public Health Service Act; 

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

9 the prescription drug product identifier require10 ment under paragraph (2) of subsections (b), 

11 (c), (d), and (e) through which— 

12 ‘‘(i) a manufacturer or repackager 

13 may request a waiver with respect to pre14 scription drug products that are packaged 

15 in a container too small or otherwise un16 able to accommodate a label with sufficient 

17 space to bear the information required for 

18 compliance with such requirement; and 

19 ‘‘(ii) the Secretary determines whether 

20 to waive such requirement; and 

21 ‘‘(C) establish a process by which the Sec22 retary may add the prescription drug products 

23 or transactions that are exempt from the re24 quirements of this section. 


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1 ‘‘(4) GRANDFATHERED PERSONS AND PRE2 SCRIPTION DRUG PRODUCTS.— 

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

4 year after the date of the enactment of the 

5 Safeguarding America’s Pharmaceuticals Act of 

6 2013, the Secretary shall specify, by regulation, 

7 whether and under what circumstances the pre8 scription drug product identifier requirement 

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

10 and (e) shall apply to a prescription drug prod11 uct that is in the supply chain on the date of 

12 the enactment of the Safeguarding America’s 

13 Pharmaceuticals Act of 2013. 

14 ‘‘(B) THIRD-PARTY LOGISTICS PROVIDER

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

16 the effective date of the third-party logistics 

17 provider licensing requirements under section 

18 584, a third-party logistics provider shall be 

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

20 unless the Secretary has made a finding that 

21 the third-party logistics provider does not utilize 

22 good handling and distribution practices and 

23 publishes notice thereof. 

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

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1 scription drug product identifier may be sub2 mitted to the Secretary in the annual report of 

3 an establishment, in accordance with section 

4 314.70(d) of chapter 21, Code of Federal Regu5 lations (or any successor regulation). 

6 ‘‘(b) MANUFACTURER REQUIREMENTS.— 

7 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRAC8 ING.— 

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

10 than January 1, 2015, a manufacturer shall— 

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

12 transaction in which such manufacturer 

13 transfers ownership of a prescription drug 

14 product, provide the subsequent owner 

15 with the transaction history and a trans16 action statement; and 

17 ‘‘(ii) maintain the transaction infor18 mation for each such transaction for not 

19 less than 3 years after the date of the 

20 transaction. 

21 ‘‘(B) REQUESTS FOR INFORMATION.— 

22 Upon a request by the Secretary or other ap23 propriate Federal or State official, in the event 

24 of a recall or for the purpose of investigating a 

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1 imate prescription drug product, a manufac2 turer shall, not later than 2 business days after 

3 receiving the request or in such reasonable time 

4 as determined by the Secretary, provide to the 

5 Secretary or other official, the applicable trans6 action history and transaction statement for the 

7 prescription drug product. 

8 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI9 FIER.—Beginning not later than 5 years after the 

10 date of the enactment of the Safeguarding America’s 

11 Pharmaceuticals Act of 2013, a manufacturer shall 

12 affix or imprint a prescription drug product identi13 fier on each package and homogenous case of a pre14 scription drug product intended to be introduced in 

15 a transaction. Such manufacturer shall maintain a 

16 copy of the prescription drug product identifier for 

17 such prescription drug product for not less than 3 

18 years after the date of the transaction. 

19 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Be20 ginning not later than January 1, 2015, a manufac21 turer shall ensure that each of its trading partners 

22 is authorized. 

23 ‘‘(4) LIST OF AUTHORIZED DISTRIBUTORS OF

24 RECORD.—Beginning not later than January 1, 


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•HR 1919 IH

1 2015, each manufacturer of a prescription drug 

2 shall— 

3 ‘‘(A) maintain a list of the authorized dis4 tributors of record of such drug at the cor5 porate offices of such manufacturer; 

6 ‘‘(B) make such list publicly available, in7 cluding placement on the Internet Website of 

8 such manufacturer; and 

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

10 per quarter. 

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

12 January 1, 2015, a manufacturer shall implement 

13 systems and processes to enable the manufacturer to 

14 comply with the following requirements: 

15 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD16 UCT.— 

17 ‘‘(i) IN GENERAL.—Upon making a 

18 determination that a prescription drug 

19 product in the possession or control of the 

20 manufacturer is a suspect prescription 

21 drug product, or upon receiving a request 

22 for verification from the Secretary that a 

23 prescription drug product within the pos24 session or control of a manufacturer is a 

25 suspect prescription drug product, a manuVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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•HR 1919 IH

1 facturer shall promptly conduct an inves2 tigation in coordination with trading part3 ners, as applicable, to determine whether 

4 the prescription drug product is an illegit5 imate prescription drug product. Beginning 

6 not later than 5 years after the date of the 

7 enactment of the Safeguarding America’s 

8 Pharmaceuticals Act of 2013, such inves9 tigation shall include— 

10 ‘‘(I) verifying the prescription 

11 drug product at the package level; 

12 ‘‘(II) validating any applicable 

13 transaction history in the possession 

14 of the manufacturer; and 

15 ‘‘(III) otherwise investigating to 

16 determine whether the prescription 

17 drug product is an illegitimate pre18 scription drug product. 

19 ‘‘(ii) CLEARED PRESCRIPTION DRUG

20 PRODUCT.—If the manufacturer deter21 mines that a suspect prescription drug 

22 product is not an illegitimate prescription 

23 drug product, the manufacturer shall 

24 promptly notify the Secretary of such deVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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•HR 1919 IH

1 termination and such prescription drug 

2 product may be further distributed. 

3 ‘‘(iii) RECORDS.—A manufacturer 

4 shall keep records of its investigation of a 

5 suspect prescription drug product for not 

6 less than 3 years after the conclusion of 

7 the investigation. 

8 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

9 PRODUCT.— 

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

11 that a prescription drug product in the 

12 possession or control of a manufacturer is 

13 an illegitimate prescription drug product, 

14 the manufacturer shall— 

15 ‘‘(I) quarantine such prescription 

16 drug product from prescription drug 

17 product intended for distribution; and 

18 ‘‘(II) provide for the disposition 

19 of the illegitimate prescription drug 

20 product. 

21 ‘‘(ii) TRADING PARTNER.—Upon de22 termining that a prescription drug product 

23 in the possession or control of a trading 

24 partner is an illegitimate prescription drug 

25 product, the manufacturer shall take reaVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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•HR 1919 IH

1 sonable steps to assist a trading partner to 

2 provide for the disposition of the illegit3 imate prescription drug product. 

4 ‘‘(iii) MAKING A NOTIFICATION.— 

5 Upon determining that a prescription drug 

6 product in the possession or control of the 

7 manufacturer is an illegitimate prescrip8 tion drug product, the manufacturer shall 

9 notify the Secretary of such determination 

10 not later than 24 hours after making such 

11 determination. The Secretary shall deter12 mine whether additional trading partner 

13 notification is appropriate. 

14 ‘‘(iv) RESPONDING TO A NOTIFICA15 TION.—Upon the receipt of a notification 

16 from the Secretary that a determination 

17 has been made that a prescription drug 

18 product is an illegitimate prescription drug 

19 product, a manufacturer shall— 

20 ‘‘(I) identify all illegitimate pre21 scription drug products that are sub22 ject to such notification and in the 

23 possession or control of the manufac24 turer, including any prescription drug 


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30 

•HR 1919 IH

1 product that is subsequently received; 

2 and 

3 ‘‘(II) perform the activities de4 scribed in clause (i). 

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

6 keep records of the disposition of an illegit7 imate prescription drug product for not 

8 less than 3 years after the conclusion of 

9 the disposition. 

10 ‘‘(C) ELECTRONIC DATABASE.—A manu11 facturer may satisfy the requirements of this 

12 paragraph through the use of a secure elec13 tronic database developed and operated by the 

14 manufacturer or another entity. The owner of 

15 such database shall establish the requirements 

16 and processes to respond to requests and may 

17 provide for data access to other members of the 

18 pharmaceutical distribution supply chain, as ap19 propriate. The development and operation of 

20 such a database shall not relieve a manufac21 turer of the requirement under this paragraph 

22 to respond to a verification request submitted 

23 by means other than a secure electronic data24 base. 


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•HR 1919 IH

1 ‘‘(D) RETURNED PRESCRIPTION DRUG

2 PRODUCT.—Beginning not later than 5 years 

3 after the date of the enactment of the Safe4 guarding America’s Pharmaceuticals Act of 

5 2013, upon receipt of a returned prescription 

6 drug product that the manufacturer intends to 

7 further distribute, before further distributing 

8 such prescription drug product, the manufac9 turer shall— 

10 ‘‘(i) verify the prescription drug prod11 uct identifier for each sealed homogeneous 

12 case of such prescription drug product; or 

13 ‘‘(ii) if such prescription drug product 

14 is not in a sealed homogeneous case, verify 

15 the prescription drug product identifier on 

16 each package. 

17 ‘‘(c) WHOLESALE DISTRIBUTOR REQUIREMENTS.— 

18 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRAC19 ING.— 

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

21 than April 1, 2015, a wholesale distributor 

22 shall— 

23 ‘‘(i) not accept ownership of a pre24 scription drug product unless the previous 

25 owner prior to, or at the time of, the transVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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32 

•HR 1919 IH

1 action provides the applicable transaction 

2 history and a transaction statement for the 

3 prescription drug product; 

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

5 transaction in which the wholesale dis6 tributor transfers ownership of a prescrip7 tion drug product— 

8 ‘‘(I) in the case that the whole9 sale distributor purchased the pre10 scription drug product directly from 

11 the manufacturer, provide the subse12 quent owner with transaction history 

13 and a transaction statement for the 

14 prescription drug product; or 

15 ‘‘(II) in the case that the whole16 sale distributor did not purchase the 

17 prescription drug product directly 

18 from the manufacturer, the exclusive 

19 distributor of the manufacturer, or a 

20 repackager that purchased directly 

21 from the manufacturer, provide the 

22 subsequent owner with transaction 

23 history beginning with the wholesale 

24 distributor that did purchase the 

25 product directly from the manufacVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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•HR 1919 IH

1 turer, the exclusive distributor of the 

2 manufacturer, or a repackager that 

3 purchased directly from the manufac4 turer; 

5 ‘‘(iii) notwithstanding clause (ii), if 

6 the wholesale distributor purchased the 

7 prescription drug product directly from the 

8 manufacturer, its exclusive distributor, or 

9 a repackager that purchased directly from 

10 the manufacturer or its authorized dis11 tributor of record— 

12 ‘‘(I) provide an initial purchase 

13 transaction statement on the invoice 

14 to the customer, stating that the 

15 wholesale distributor purchased the 

16 prescription drug product package di17 rectly from the manufacturer, exclu18 sive distributor, or repackager; 

19 ‘‘(II) make available to the imme20 diate subsequent recipient of such 

21 prescription drug product the infor22 mation required under clause (ii) 

23 through any combination of self-gen24 erated paper, electronic data, or man25 ufacturer provided information on the 


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34 

•HR 1919 IH

1 prescription drug product package; 

2 and 

3 ‘‘(III) for purposes of subclauses 

4 (I) and (II), need not include any 

5 transactions occurring before the 

6 transfer of the prescription drug prod7 uct to the wholesale distributor; and 

8 ‘‘(iv) maintain the transaction infor9 mation for each transaction described in 

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

11 years after the transaction. 

12 ‘‘(B) RETURNS EXCEPTION.— 

13 ‘‘(i) SALEABLE RETURNS.—Notwith14 standing subparagraph (A), a wholesale 

15 distributor may— 

16 ‘‘(I) accept returned prescription 

17 drug product without a transaction 

18 history from a dispenser; and 

19 ‘‘(II) distribute such returned 

20 prescription drug product with a 

21 transaction history that begins with 

22 the wholesale distributor that so ac23 cepted the returned product. 

24 ‘‘(ii) NONSALEABLE RETURNS.—A 

25 wholesale distributor may return a nonVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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35 

•HR 1919 IH

1 saleable prescription drug to the manufac2 turer or repackager, to the wholesale dis3 tributor from whom such prescription drug 

4 was purchased, or to a person acting on 

5 behalf of such a person, including a re6 turns processor, without providing the in7 formation required under subparagraph 

8 (A). 

9 ‘‘(C) REQUESTS FOR INFORMATION.— 

10 Upon a request by the Secretary or other ap11 propriate Federal or State official, in the event 

12 of a recall or for the purpose of investigating a 

13 suspect prescription drug product or an illegit14 imate prescription drug product a wholesale dis15 tributor shall, not later than 2 business days 

16 after receiving the request or in such other rea17 sonable time as determined by the Secretary, 

18 provide the applicable transaction history and 

19 transaction statements for the prescription drug 

20 product. 

21 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI22 FIER.—Beginning not later than 7 years after the 

23 date of the enactment of the Safeguarding America’s 

24 Pharmaceuticals Act of 2013, a wholesale distributor 

25 may engage in transactions involving a prescription 


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36 

•HR 1919 IH

1 drug product only if such prescription drug product 

2 is encoded with a prescription drug product identi3 fier, except as provided in subsection (a)(4). 

4 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Be5 ginning not later than January 1, 2015, a wholesale 

6 distributor shall ensure that each of its trading part7 ners is authorized. 

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

9 April 1, 2015, a wholesale distributor shall imple10 ment systems to enable the wholesale distributor to 

11 comply with the following requirements: 

12 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD13 UCT.— 

14 ‘‘(i) IN GENERAL.—Upon making a 

15 determination that a prescription drug 

16 product in the possession or control of the 

17 wholesale distributor is a suspect prescrip18 tion drug product, or upon receiving a re19 quest for verification from the Secretary 

20 that a prescription drug product within the 

21 possession or control of a wholesale dis22 tributor is a suspect prescription drug 

23 product, a wholesale distributor shall 

24 promptly conduct an investigation to deter25 mine whether the prescription drug prodVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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37 

•HR 1919 IH

1 uct is an illegitimate prescription drug 

2 product. Beginning not later than 7 years 

3 after the date of the enactment of the 

4 Safeguarding America’s Pharmaceuticals 

5 Act of 2013, such investigation shall in6 clude— 

7 ‘‘(I) verifying a package of the 

8 prescription drug product; 

9 ‘‘(II) validating any applicable 

10 transaction history in the possession 

11 of the wholesale distributor; and 

12 ‘‘(III) otherwise investigating to 

13 determine whether the prescription 

14 drug product is an illegitimate pre15 scription drug product. 

16 ‘‘(ii) CLEARED PRESCRIPTION DRUG

17 PRODUCT.—If the wholesale distributor de18 termines that a suspect prescription drug 

19 product is not an illegitimate prescription 

20 drug product, the wholesale distributor 

21 shall promptly notify the Secretary of such 

22 determination and such prescription drug 

23 product may be further distributed. 

24 ‘‘(iii) RECORDS.—A wholesale dis25 tributor shall keep records of its investigaVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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38 

•HR 1919 IH

1 tion of a suspect prescription drug product 

2 for not less than 3 years after the conclu3 sion of the investigation. 

4 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

5 PRODUCT.— 

6 ‘‘(i) IN GENERAL.—Upon receiving 

7 notice that a manufacturer of a prescrip8 tion drug product has determined that a 

9 prescription drug product in the possession 

10 or control of a wholesale distributor is an 

11 illegitimate prescription drug product, the 

12 wholesale distributor shall— 

13 ‘‘(I) quarantine such prescription 

14 drug product within the possession or 

15 control of the manufacturer from pre16 scription drug product intended for 

17 distribution; and 

18 ‘‘(II) provide for the disposition 

19 of the illegitimate prescription drug 

20 product within the possession or con21 trol of the wholesale distributor. 

22 ‘‘(ii) TRADING PARTNER.—Upon de23 termining that a prescription drug product 

24 in the possession or control of a trading 

25 partner is an illegitimate prescription drug 


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39 

•HR 1919 IH

1 product, the wholesale distributor shall 

2 take reasonable steps to assist a trading 

3 partner to provide for the disposition of 

4 the illegitimate prescription drug product. 

5 ‘‘(iii) MAKING A NOTIFICATION.— 

6 Upon determining that a prescription drug 

7 product in the possession or control of the 

8 wholesale distributor is an illegitimate pre9 scription drug product, the wholesale dis10 tributor shall notify the Secretary of such 

11 determination not later than 24 hours 

12 after making such determination. The Sec13 retary shall determine whether additional 

14 trading partner notification is appropriate. 

15 ‘‘(iv) RESPONDING TO A NOTIFICA16 TION.—Upon the receipt of a notification 

17 from the Secretary that a determination 

18 has been made that a prescription drug 

19 product is an illegitimate prescription drug 

20 product, a wholesale distributor shall— 

21 ‘‘(I) identify all illegitimate pre22 scription drug product subject to such 

23 notification that is in the possession 

24 or control of the wholesale distributor, 


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40 

•HR 1919 IH

1 including any prescription drug prod2 uct that is subsequently received; and 

3 ‘‘(II) perform the activities de4 scribed in clause (i). 

5 ‘‘(v) RECORDS.—A wholesale dis6 tributor shall keep records of the disposi7 tion of an illegitimate prescription drug 

8 product for not less than 3 years after the 

9 conclusion of the disposition. 

10 ‘‘(C) ELECTRONIC DATABASE.—A whole11 sale distributor may satisfy the requirements of 

12 this paragraph through the use of a secure elec13 tronic database developed and operated by the 

14 manufacturer or another entity. The owner of 

15 such database shall establish the requirements 

16 and processes to respond to requests and may 

17 provide for data access to other members of the 

18 pharmaceutical distribution supply chain, as ap19 propriate. The development and operation of 

20 such a database shall not relieve a wholesale 

21 distributor of the requirement under this para22 graph to respond to a verification request sub23 mitted by means other than a secure electronic 

24 database. 


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41 

•HR 1919 IH

1 ‘‘(D) RETURNED PRESCRIPTION DRUG

2 PRODUCT.—Beginning not later than 7 years 

3 after the date of the enactment of the Safe4 guarding America’s Pharmaceuticals Act of 

5 2013, upon receipt of a returned prescription 

6 drug product that the wholesale distributor in7 tends to further distribute, before further dis8 tributing such prescription drug product, the 

9 wholesale distributor shall— 

10 ‘‘(i) verify the prescription drug prod11 uct identifier for each sealed homogeneous 

12 case of such prescription drug product; or 

13 ‘‘(ii) if such prescription drug product 

14 is not in a sealed homogeneous case, verify 

15 the prescription drug product identifier on 

16 each package. 

17 ‘‘(d) DISPENSER REQUIREMENTS.— 

18 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRAC19 ING.— 

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

21 than July 1, 2015, a dispenser— 

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

23 prescription drug product, unless the pre24 vious owner prior to, or at the time of, the 


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42 

•HR 1919 IH

1 transaction, provides transaction history 

2 and a transaction statement; 

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

4 transaction in which the dispenser trans5 fers ownership of a prescription drug prod6 uct (but not including dispensing to a pa7 tient or returns) shall provide the subse8 quent owner with transaction history and a 

9 transaction statement for the prescription 

10 drug product, except that the requirements 

11 of this clause shall not apply to sales by a 

12 dispenser to another dispenser to fulfill a 

13 specific patient need; and 

14 ‘‘(iii) shall maintain transaction infor15 mation for a period of not less than 3 

16 years after the date of the transaction. 

17 ‘‘(B) AGREEMENTS WITH THIRD PAR18 TIES.—A dispenser may enter into a written 

19 agreement with a third party, including an au20 thorized wholesale distributor, under which the 

21 third party confidentially maintains the trans22 action information required to be maintained 

23 under this subsection on behalf of the dis24 penser. If a dispenser enters into such an 


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43 

•HR 1919 IH

1 agreement, the dispenser shall maintain a copy 

2 of the written agreement. 

3 ‘‘(C) RETURNS EXCEPTION.— 

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

6 may return prescription drug product to 

7 the trading partner from which the dis8 penser obtained the prescription drug 

9 product without providing the information 

10 required under such subparagraph. 

11 ‘‘(ii) NONSALEABLE RETURNS.—Not12 withstanding subparagraph (A)(ii), a dis13 penser may return a nonsaleable prescrip14 tion drug to the manufacturer or repack15 ager, to the wholesale distributor from 

16 whom such prescription drug was pur17 chased, to a returns processor, or to a per18 son acting on behalf of such persons with19 out providing the information required 

20 under such subparagraph. 

21 ‘‘(D) REQUESTS FOR INFORMATION.— 

22 Upon a request by the Secretary or other ap23 propriate Federal or State official, in the event 

24 of a recall or for the purpose of investigating a 

25 suspect prescription drug product or an illegitVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00043 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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44 

•HR 1919 IH

1 imate prescription drug product, a dispenser 

2 shall, not later than 2 business days after re3 ceiving the request or in another such reason4 able time as determined by the Secretary, pro5 vide lot level transaction information. 

6 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI7 FIER.—Beginning not later than 8 years after the 

8 date of the enactment of the Safeguarding America’s 

9 Pharmaceuticals Act of 2013, a dispenser may en10 gage in transactions involving a prescription drug 

11 product only if such prescription drug product is en12 coded with a prescription drug product identifier, ex13 cept as provided in subsection (a)(4). 

14 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Be15 ginning not later than January 1, 2015, a dispenser 

16 shall ensure that each of its trading partners is au17 thorized. 

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

19 January 1, 2015, a dispenser shall implement sys20 tems to enable the dispenser to comply with the fol21 lowing requirements: 

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

24 ‘‘(i) IN GENERAL.—Upon making a 

25 determination that a prescription drug 


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45 

•HR 1919 IH

1 product in the possession or control of the 

2 dispenser is a suspect prescription drug 

3 product, or upon receiving a request for 

4 verification from the Secretary that a pre5 scription drug product within the posses6 sion or control of a dispenser is a suspect 

7 prescription drug product, a dispenser 

8 shall promptly conduct an investigation to 

9 determine whether the prescription drug 

10 product is an illegitimate prescription drug 

11 product. Such investigation shall include— 

12 ‘‘(I) verifying whether the lot 

13 number of a suspect prescription drug 

14 product corresponds with the lot num15 ber for such prescription drug prod16 uct; 

17 ‘‘(II) beginning 8 years after the 

18 date of the enactment of the Safe19 guarding America’s Pharmaceuticals 

20 Act of 2013, verifying that the prod21 uct identifier of at least 3 packages or 

22 10 percent of such suspect prescrip23 tion drug product, whichever is great24 er, or all packages, if there are fewer 

25 than 3, corresponds with the prescripVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00045 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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46 

•HR 1919 IH

1 tion drug product identifier for such 

2 product; 

3 ‘‘(III) validating any applicable 

4 transaction history in the possession 

5 of the dispenser; and 

6 ‘‘(IV) 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 dispenser makes the de12 termination that a suspect prescription 

13 drug product is not an illegitimate pre14 scription drug product, the dispenser shall 

15 promptly notify the Secretary of such de16 termination and such prescription drug 

17 product may be further dispensed. 

18 ‘‘(iii) RECORDS.—A dispenser shall 

19 keep records of its investigation of a sus20 pect prescription drug product for not less 

21 than 3 years after the conclusion of the in22 vestigation. 

23 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

24 PRODUCT.— 


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47 

•HR 1919 IH

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 dispenser is an illegitimate 

6 prescription drug product, the dispenser 

7 shall— 

8 ‘‘(I) quarantine such prescription 

9 drug product within the possession or 

10 control of the dispenser from prescrip11 tion drug product intended for dis12 tribution; and 

13 ‘‘(II) provide for the disposition 

14 of the illegitimate prescription drug 

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

17 ‘‘(ii) TRADING PARTNERS.—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 dispenser shall take reason22 able steps to assist a trading partner to 

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


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•HR 1919 IH

1 ‘‘(iii) MAKING A NOTIFICATION.— 

2 Upon determining that a prescription drug 

3 product in the possession or control of the 

4 dispenser is an illegitimate prescription 

5 drug product, the dispenser shall notify the 

6 Secretary of such determination not later 

7 than 24 hours after making such deter8 mination. 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 dispenser 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 dispenser, 

21 including any prescription drug prod22 uct that is subsequently received; and 

23 ‘‘(II) perform the activities de24 scribed in clause (i). 


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49 

•HR 1919 IH

1 ‘‘(v) RECORDS.—A dispenser 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 dis7 penser may satisfy the requirements of this 

8 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 enable responding to requests 

13 and may provide for data access to other mem14 bers of the pharmaceutical distribution supply 

15 chain, as appropriate. The development and op16 eration of such a database shall not relieve a 

17 dispenser 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 ‘‘(e) REPACKAGER REQUIREMENTS.— 

22 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRAC23 ING.— 

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

25 than January 1, 2015, a repackager shall— 


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50 

•HR 1919 IH

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

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

4 transaction, provides transaction history 

5 and a transaction statement for the pre6 scription drug product; 

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

8 transaction in which the repackager trans9 fers ownership of a prescription drug prod10 uct, provide the subsequent owner with 

11 transaction history and a transaction state12 ment; 

13 ‘‘(iii) maintain the transaction infor14 mation for each transaction described in 

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

16 after the transaction; and 

17 ‘‘(iv) maintain records that allow the 

18 repackager to associate the prescription 

19 drug product identifier the repackager af20 fixes or imprints with the prescription drug 

21 product identifier assigned by the original 

22 manufacturer of the prescription drug 

23 product. 

24 ‘‘(B) NONSALEABLE RETURNS.—A repack25 ager may return a nonsaleable prescription 


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51 

•HR 1919 IH

1 drug product to the manufacturer or repack2 ager, to the wholesale distributor from whom 

3 such prescription drug product was purchased, 

4 or to a person acting on behalf of such a per5 son, including a returns processor, without pro6 viding the information required under subpara7 graph (A)(ii). 

8 ‘‘(C) REQUESTS FOR INFORMATION.— 

9 Upon a request by the Secretary or other ap10 propriate Federal or State official, in the event 

11 of a recall or for the purpose of investigating a 

12 suspect prescription drug product or an illegit13 imate prescription drug product, a repackager 

14 shall, not later than 2 business days after re15 ceiving the request or in such other reasonable 

16 time as determined by the Secretary, provide 

17 the applicable transaction history and trans18 action statement for the prescription drug prod19 uct. 

20 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI21 FIER.—Beginning not later than 6 years after the 

22 date of the enactment of the Safeguarding America’s 

23 Pharmaceuticals Act of 2013, a repackager— 

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

25 drug product identifier to each package and hoVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00051 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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•HR 1919 IH

1 mogenous case of prescription drug product in2 tended to be introduced in a transaction; 

3 ‘‘(B) shall maintain the prescription drug 

4 product identifier for such prescription drug 

5 product for not less than 3 years after the date 

6 of the transaction; and 

7 ‘‘(C) may engage in transactions involving 

8 a prescription drug product only if such pre9 scription drug product is encoded with a pre10 scription drug product identifier except as pro11 vided in subsection (a)(4). 

12 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Be13 ginning on January 1, 2015, a repackager shall en14 sure that each of its trading partners is authorized. 

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

16 January 1, 2015, a repackager shall implement sys17 tems to enable the repackager to comply with the 

18 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 repackager is a suspect prescription drug 

25 product, or upon receiving a request for 


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1 verification from the Secretary that a pre2 scription drug product within the posses3 sion or control of a repackager is a suspect 

4 prescription drug product, a repackager 

5 shall promptly conduct an investigation to 

6 determine whether the prescription drug 

7 product is an illegitimate prescription drug 

8 product, including— 

9 ‘‘(I) beginning not later than 6 

10 years after the date of the enactment 

11 of the Safeguarding America’s Phar12 maceuticals Act of 2013, verifying the 

13 prescription drug product at the pack14 age level; 

15 ‘‘(II) validating any applicable 

16 transaction information in the posses17 sion of the repackager; and 

18 ‘‘(III) otherwise investigating to 

19 determine whether the prescription 

20 drug product is an illegitimate pre21 scription drug product. 

22 ‘‘(ii) CLEARED PRESCRIPTION DRUG

23 PRODUCT.—If the repackager determines 

24 that a suspect prescription drug product is 

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1 uct, the repackager shall promptly notify 

2 the Secretary of such determination and 

3 such prescription drug product may be fur4 ther distributed. 

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

6 keep records of its investigation of a sus7 pect prescription drug product for not less 

8 than 3 years after the conclusion of the in9 vestigation. 

10 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

11 PRODUCT.— 

12 ‘‘(i) IN GENERAL.—Upon receiving 

13 notice that a manufacturer of a prescrip14 tion drug product has determined that a 

15 prescription drug product in the possession 

16 or control of a repackager is an illegitimate 

17 prescription drug product, the repackager 

18 shall— 

19 ‘‘(I) quarantine such prescription 

20 drug product within the possession or 

21 control of the repackager from pre22 scription drug product intended for 

23 distribution; and 

24 ‘‘(II) provide for the disposition 

25 of the illegitimate prescription drug 


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

3 ‘‘(ii) TRADING PARTNER.—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 repackagers shall take reason8 able steps to assist the 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 repackager is an illegitimate prescription 

15 drug product, the repackager shall notify 

16 the Secretary of such determination not 

17 later than 24 hours after making such de18 termination. 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 repackager 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 repack7 ager, including any prescription drug 

8 product that is subsequently received; 

9 and 

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

12 ‘‘(v) RECORDS.—A repackager 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 repack18 ager may satisfy the requirements of this para19 graph through the use of a secure electronic 

20 database developed and operated by the manu21 facturer or another entity. The owner of such 

22 database shall establish the requirements and 

23 processes to respond to requests and may pro24 vide for data access to other members of the 

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1 propriate. The development and operation of 

2 such a database shall not relieve a repackager 

3 of the requirement under this paragraph to re4 spond to a verification request submitted by 

5 means other than a secure electronic database. 

6 ‘‘(D) RETURNED PRESCRIPTION DRUG

7 PRODUCT.—Beginning not later than 6 years 

8 after the date of the enactment of the Safe9 guarding America’s Pharmaceuticals Act of 

10 2013, upon receipt of a returned prescription 

11 drug product that the repackager intends to 

12 further distribute, before further distributing 

13 such prescription drug product, the repackager 

14 shall— 

15 ‘‘(i) verify the prescription drug prod16 uct identifier for each sealed homogeneous 

17 case of such prescription drug product; or 

18 ‘‘(ii) if such prescription drug product 

19 is not in a sealed homogeneous case, verify 

20 the prescription drug product identifier on 

21 each package. 

22 ‘‘(f) THIRD-PARTY LOGISTICS PROVIDER REQUIRE23 MENTS.— 

24 ‘‘(1) AUTHORIZED TRADING PARTNERS.—Be25 ginning on January 1, 2015, a third-party logistics 


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1 provider shall ensure that each of its trading part2 ners is authorized. 

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

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

5 shall implement systems to enable the third-party lo6 gistics provider to comply with the following require7 ments: 

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 a 

13 third-party logistics provider is a suspect 

14 prescription drug product, a third-party lo15 gistics provider shall promptly notify the 

16 owner of such prescription drug product of 

17 the need to conduct an investigation to de18 termine whether the prescription drug 

19 product is an illegitimate prescription drug 

20 product. 

21 ‘‘(ii) CLEARED PRESCRIPTION DRUG

22 PRODUCT.—If the owner of the prescrip23 tion drug product notifies the third-party 

24 logistics provider of the determination that 

25 a suspect prescription drug product is not 


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1 an illegitimate prescription drug product, 

2 such prescription drug product may be fur3 ther distributed. 

4 ‘‘(iii) RECORDS.—A third-party logis5 tics provider shall keep records of the ac6 tivities described in clauses (i) and (ii) 

7 with respect to a suspect prescription drug 

8 product for not less than 3 years after the 

9 conclusion of the investigation. 

10 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

11 PRODUCT.— 

12 ‘‘(i) IN GENERAL.—Upon receiving 

13 notice that a manufacturer of a prescrip14 tion drug product has determined that a 

15 prescription drug product in the possession 

16 or control of a third-party logistics pro17 vider is an illegitimate prescription drug 

18 product, the third-party logistics provider 

19 shall— 

20 ‘‘(I) quarantine such prescription 

21 drug product within the possession or 

22 control of the third-party logistics pro23 vider from prescription drug product 

24 intended for distribution; 


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1 ‘‘(II) promptly notify the owner 

2 of such prescription drug product of 

3 the need to provide for the disposition 

4 of such prescription drug product; and 

5 ‘‘(III) promptly transfer posses6 sion of the prescription drug product 

7 to the owner of such prescription drug 

8 product to provide for the disposition 

9 of the prescription drug product. 

10 ‘‘(ii) MAKING A NOTIFICATION.— 

11 Upon determining that a prescription drug 

12 product in the possession or control of the 

13 third-party logistics provider is an illegit14 imate prescription drug product, the third15 party logistics provider shall notify the 

16 Secretary not later than 24 hours after 

17 making such determination. The Secretary 

18 shall determine whether additional trading 

19 partner notification is appropriate. 

20 ‘‘(iii) RESPONDING TO A NOTIFICA21 TION.—Upon the receipt of a notification 

22 from the Secretary, a third-party logistics 

23 provider shall— 

24 ‘‘(I) identify all illegitimate pre25 scription drug product subject to such 


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1 notification that is in the possession 

2 or control of the third-party logistics 

3 provider, including any prescription 

4 drug product that is subsequently re5 ceived; and 

6 ‘‘(II) perform the activities de7 scribed in clause (i). 

8 ‘‘(iv) RECORDS.—A third-party logis9 tics provider shall keep records of the ac10 tivities described in clauses (i) and (ii) 

11 with respect to an illegitimate prescription 

12 drug product for not less than 3 years 

13 after the conclusion of the disposition. 

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

15 to any entity, notwithstanding its status as a wholesale 

16 distributor or repackager, or other status that is not in17 volved in the physical handling, distribution, or storage of 

18 a prescription drug product. For purposes of this sub19 section, facilitating the distribution of a prescription drug 

20 product by providing various administrative services, in21 cluding processing of orders and payments, shall not, by 

22 itself, be construed as being involved in the handling, dis23 tribution, or storage of a prescription drug product.’’. 

24 SEC. 3. ENHANCED DRUG DISTRIBUTION SECURITY. 

25 (a) PILOT PROJECTS.— 


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

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

3 shall establish one or more pilot projects in coordi4 nation with manufacturers, repackagers, wholesale 

5 distributors, third-party logistics providers, and dis6 pensers to explore and evaluate methods to enhance 

7 the safety and security of the pharmaceutical dis8 tribution supply chain. 

9 (2) CONTENT.— 

10 (A) IN GENERAL.—The Secretary shall en11 sure that the pilot projects under paragraph (1) 

12 collectively— 

13 (i) reflect the diversity of the pharma14 ceutical distribution supply chain; and 

15 (ii) include participants representative 

16 of every sector within the pharmaceutical 

17 distribution supply chain, including partici18 pants representative of small businesses. 

19 (B) PROJECT DESIGN.—The pilot projects 

20 shall be designed to— 

21 (i) utilize the prescription drug prod22 uct identifier for tracing of a prescription 

23 drug product, which utilization may in24 clude— 


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1 (I) verification of the prescription 

2 drug product identifier of a prescrip3 tion drug product; and 

4 (II) the use of aggregation and 

5 inference; 

6 (ii) improve the technical capabilities 

7 of each sector within the pharmaceutical 

8 supply chain to comply with systems and 

9 processes needed to utilize the prescription 

10 drug product identifiers to enhance tracing 

11 of a prescription drug product; and 

12 (iii) conduct such other activities as 

13 the Secretary determines appropriate to 

14 explore and evaluate methods to enhance 

15 the safety and security of the pharma16 ceutical distribution supply chain. 

17 (b) PUBLIC MEETINGS.— 

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

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

20 least every 6 months thereafter until the submission 

21 of the report required by subsection (d)(2), the Sec22 retary shall hold a public meeting to enhance the 

23 safety and security of the pharmaceutical distribu24 tion supply chain. In conducting such meetings, the 

25 Secretary shall take all measures reasonable and 


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1 practicable to ensure the protection of confidential 

2 commercial information and trade secrets. 

3 (2) CONTENT.—In conducting meetings under 

4 this subsection, the Secretary shall seek to address, 

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

6 topics: 

7 (A) Best practices in each of the sectors 

8 within the pharmaceutical distribution supply 

9 chain to implement the requirements of section 

10 582 of the Federal Food, Drug, and Cosmetic 

11 Act, as added by section 2. 

12 (B) The costs and benefits of implementa13 tion of such section 582, including the impact 

14 on each pharmaceutical distribution supply 

15 chain sector and on public health. 

16 (C) Whether additional electronic 

17 traceability requirements, including tracing of 

18 prescription drug product at the package level, 

19 are feasible, cost effective, overly burdensome 

20 on small businesses, and needed to protect pub21 lic health. 

22 (D) The systems and processes needed to 

23 utilize the prescription drug product identifiers 

24 to enhance tracing of prescription drug product 

25 at the package level. 


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1 (E) The technical capabilities and legal au2 thorities, if any, needed to establish an elec3 tronic system that provides for enhanced trac4 ing of prescription drug product at the package 

5 level. 

6 (F) The impact that the requirements, sys7 tems, processes, capabilities, and legal authori8 ties referred to in subparagraphs (C), (D), and 

9 (E) would have on patient safety, the drug sup10 ply, cost and regulatory burden, the timeliness 

11 of patient access to prescription drugs, and 

12 small businesses. 

13 (c) STUDY OF THE PHARMACEUTICAL DISTRIBUTION

14 SUPPLY CHAIN.— 

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

16 the United States shall conduct a study to examine 

17 implementation of the requirements established 

18 under subchapter H of chapter V of the Federal 

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

20 2, in order to inform the regulations promulgated 

21 under this section. 

22 (2) CONSIDERATION.—In conducting the study 

23 under this subsection, the Comptroller General shall 

24 provide for stakeholder input and shall consider the 

25 following: 


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1 (A) The implementation of the require2 ments established under such subchapter H 

3 with respect to— 

4 (i) the ability of the health care sys5 tem collectively to maintain patient access 

6 to medicines; 

7 (ii) the scalability of such require8 ments, including with respect to prescrip9 tion drug product lines; and 

10 (iii) the capability of different sectors 

11 within the pharmaceutical distribution sup12 ply chain, including small businesses, to 

13 affix and utilize the prescription drug 

14 product identifier. 

15 (B) The need for additional legal authori16 ties and activities to address additional gaps in 

17 the pharmaceutical distribution supply chain, if 

18 any, after the implementation of the require19 ments established under such subchapter H 

20 with respect to— 

21 (i) the systems and processes needed 

22 to enhance tracing of prescription drug 

23 product at the package level; 

24 (ii) the impact, feasibility, and cost ef25 fectiveness that additional requirements 


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1 pursuant to this section would have on 

2 each pharmaceutical distribution supply 

3 chain sector and the public health; and 

4 (iii) the systems and processes needed 

5 to enhance interoperability among trading 

6 partners. 

7 (C) Risks to the security and privacy of 

8 data collected, maintained, or exchanged pursu9 ant to the requirements established under such 

10 subchapter H. 

11 (d) SMALL DISPENSERS.— 

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

13 after the date of the enactment of this Act, the Sec14 retary shall enter into a contract with a private, 

15 independent consulting firm with relevant expertise 

16 to conduct a technology and software study on the 

17 feasibility of dispensers that have 25 or fewer full18 time employees conducting interoperable, electronic 

19 tracing of prescription drug products at the package 

20 level. 

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

22 of a contract under paragraph (1), the private inde23 pendent consulting firm awarded such contract shall 

24 agree to consult with dispensers that have 25 or 


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1 fewer full-time employees when conducting the study 

2 under such subparagraph. 

3 (3) STUDY CONTENT.—The study conducted 

4 under paragraph (1) shall assess whether, with re5 spect to conducting interoperable, electronic tracing 

6 of prescription drug products at the package level, 

7 the necessary hardware and software— 

8 (A) is readily accessible to such dispensers; 

9 (B) is not prohibitively expensive to obtain, 

10 install and maintain for such dispensers; and 

11 (C) can be integrated into business prac12 tices, such as interoperability with wholesale 

13 distributors, for such dispensers. 

14 (4) PUBLICATION.—The Secretary shall pub15 lish— 

16 (A) the statement of work for the study 

17 conducted under paragraph (1) for public com18 ment not later than 30 days before commencing 

19 the study; and 

20 (B) the final version of such study for pub21 lic comment not later than 30 days after such 

22 study is completed. 

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

24 days after the date on which the study conducted 

25 under paragraph (1) is completed, the Secretary 


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1 shall submit to the Committee on Energy and Com2 merce of the House of Representatives and the Com3 mittee on Health, Education, Labor, and Pensions 

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

5 and any recommendations to improve the technology 

6 and software available to small dispensers for pur7 poses of conducting electronic, interoperable tracing 

8 of prescription drug products at the package level. 

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

10 days after the date on which the study conducted 

11 under paragraph (1) is completed, the Secretary 

12 shall hold a public meeting at which members of the 

13 public, including stakeholders, may present their 

14 views on the study. 

15 (e) REPORTS.— 

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

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

18 Comptroller General shall submit to the Committee 

19 on Energy and Commerce of the House of Rep20 resentatives and the Committee on Health, Edu21 cation, Labor, and Pensions of the Senate a report 

22 on the results of the study conducted under sub23 section (c). 

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

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1 retary shall submit to the Committee on Energy and 

2 Commerce of the House of Representatives and the 

3 Committee on Health, Education, Labor, and Pen4 sions of the Senate a report on the results of the 

5 pilot program conducted under subsection (a), tak6 ing into consideration— 

7 (A) the comments received during the pub8 lic meetings conducted under subsection (b); 

9 and 

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

11 the public comments received during the public 

12 meeting held, under subsection (d). 

13 (f) ESTABLISHMENT OF ADDITIONAL REQUIRE14 MENTS.— 

15 (1) IN GENERAL.—Notwithstanding any other 

16 provision of this Act, including the amendments 

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

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

19 shall issue proposed regulations that establish addi20 tional requirements to prevent a suspect product, il21 legitimate product, or a product that is counterfeit, 

22 stolen, diverted, or otherwise unfit for distribution 

23 from entering into or being further distributed in 

24 the supply chain, including— 


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1 (A) requirements related to the use of 

2 interoperable electronic systems and tech3 nologies for enhanced tracing of prescription 

4 drug product at the package level, which may 

5 include verification of the prescription drug 

6 product identifier of a package of prescription 

7 drug product and enhanced verification of sale8 able returns; 

9 (B) requirements related to the use of ad10 ditional prescription drug product identifiers or 

11 prescription drug product identifier technology 

12 that meet the standards developed under sec13 tion 582(a)(2) of the Federal Food, Drug, and 

14 Cosmetic Act, as added by section 2; 

15 (C) requirements related to the use of ag16 gregation, inference, and other methods, if de17 termined to be necessary components of the 

18 systems and technologies referred to in sub19 paragraph (A); and 

20 (D) other data transmission and mainte21 nance requirements and interoperability stand22 ards. 

23 (2) FLEXIBILITY.—The requirements described 

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

25 member of the pharmaceutical supply chain, by— 


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1 (A) with respect to dispensers, allowing a 

2 dispenser to enter into a written agreement 

3 with a third party, including an authorized 

4 wholesale distributor, under which— 

5 (i) the third party confidentially main6 tains any information required to be main7 tained under such requirements for the 

8 dispenser; and 

9 (ii) the dispenser maintains a copy of 

10 the written agreement and is not relieved 

11 of the other obligations of the dispenser 

12 under such requirements; 

13 (B) establishing a process by which an au14 thorized manufacturer, repackager, wholesale 

15 distributor, or dispenser may request a waiver 

16 from any such requirements if the Secretary de17 termines that such requirements would result in 

18 an undue economic hardship on the manufac19 turer, wholesale distributor, or dispenser; 

20 (C) not requiring the adoption of specific 

21 business systems by a member of the pharma22 ceutical supply chain for the maintenance and 

23 transmission of prescription drug product trac24 ing data; and 


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1 (D) prescribing alternative methods of 

2 compliance for small businesses, as specified in 

3 paragraph (4). 

4 (3) CONSIDERATIONS.—In issuing proposed 

5 regulations under paragraph (1), the Secretary shall 

6 consider— 

7 (A) the results of the pilot project con8 ducted under subsection (a); 

9 (B) the public meetings held under sub10 section (b); 

11 (C) the studies conducted under sub12 sections (c) and (d); 

13 (D) the reports submitted under subsection 

14 (e); 

15 (E) the public health benefits of such regu16 lations compared with the cost of compliance 

17 with the requirements contained in such regula18 tions, including with respect to entities of vary19 ing sizes and capabilities; and 

20 (F) the diversity of the pharmaceutical dis21 tribution supply chain by providing appropriate 

22 flexibility for each sector in the supply chain, 

23 including small businesses. 

24 (4) SMALL BUSINESS PROTECTION.—The Sec25 retary, taking into consideration the study conducted 


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1 under paragraph (d), shall, if the Secretary deter2 mines that the requirements established pursuant to 

3 paragraph (1) would result in an undue economic 

4 hardship on small businesses, provide for alternative 

5 methods of compliance with any such requirement by 

6 small businesses, including— 

7 (A) establishing timelines for such compli8 ance (including compliance by dispensers with 

9 25 or fewer full-time employees) that do not im10 pose undue economic hardship for small busi11 nesses, including dispensers with respect to 

12 which the study concluded has insufficient 

13 hardware and software to conduct interoper14 able, electronic tracing of prescription drug 

15 products at the package level; and 

16 (B) establishing a process by which a dis17 penser may request a waiver from any such re18 quirement. 

19 (5) REGULATIONS.—In issuing regulations to 

20 carry out this subsection, the Secretary shall— 

21 (A) issue a notice of proposed rulemaking 

22 that includes a copy of the proposed rule; 

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

24 60 days for comments on the proposed rule; 

25 and 


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1 (C) provide for an effective date of the 

2 final rule that is 2 years after the date on 

3 which such final rule is published. 

4 (6) SUNSET.—The requirements regarding the 

5 provision and receipt of transaction history and 

6 transaction statements under section 582 of the 

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

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

9 which the regulations issued under this section are 

10 fully implemented. 

11 (g) DEFINITIONS.—In this section: 

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

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

14 section 2, shall have the same meanings in this sec15 tion as such terms are given in such section 581. 

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

17 of Health and Human Services, acting through the 

18 Commissioner of Food and Drugs. 

19 SEC. 4. NATIONAL STANDARDS FOR WHOLESALE DISTRIBU20 TORS. 

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

22 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend23 ed— 

24 (1) in section 503 of such Act (21 U.S.C. 353), 

25 by striking ‘‘(e)(1)(A)’’ and all that follows through 


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1 ‘‘(3) For purposes of this subsection and subsection 

2 (d)—’’ and inserting the following: 

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

4 (2) in subchapter H of chapter V of the Federal 

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

6 2, by adding at the end the following: 

7 ‘‘SEC. 583. NATIONAL STANDARDS FOR WHOLESALE DIS8 TRIBUTORS. 

9 ‘‘(a) STANDARDS.— 

10 ‘‘(1) IN GENERAL.—The Secretary shall estab11 lish, by regulation, standards for the licensing of 

12 persons that make wholesale distributions. 

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

14 paragraph (1) shall, with respect to wholesale dis15 tributions, include requirements for— 

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

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

18 requirements; 

19 ‘‘(B) the establishment and maintenance of 

20 records of the distributions of such drugs; 

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

22 equivalent means of security in accordance with 

23 paragraph (3); 


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1 ‘‘(D) mandatory background checks and 

2 fingerprinting of facility managers or des3 ignated representatives; 

4 ‘‘(E) the establishment and implementa5 tion of qualifications for key personnel; 

6 ‘‘(F) the mandatory physical inspection of 

7 any facility to be used in wholesale distribution 

8 within a reasonable timeframe from the initial 

9 application for licensure of the wholesale dis10 tributor; and 

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

12 prohibition of certain persons from engaging in 

13 wholesale distribution. 

14 ‘‘(3) BOND OR OTHER SECURITY.—The require15 ments under paragraph (2)(C) shall provide for the 

16 following: 

17 ‘‘(A) An applicant that is not a govern18 ment-owned-and-operated wholesale distributor, 

19 for the issuance or renewal of a wholesale dis20 tributor license, shall submit a surety bond of 

21 $100,000 or other equivalent means of security 

22 acceptable to the applicable licensing authority. 

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

24 the applicable licensing authority may accept a 

25 surety bond less than $100,000 if the annual 


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1 gross receipts of the previous tax year for the 

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

3 which case the surety bond may not be less 

4 than $25,000. 

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

6 evidence that it possesses the required bond in 

7 a State, the requirement for a bond in another 

8 State is waived. 

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

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

11 may conduct the inspection, or may accept an in12 spection by— 

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

14 the facility is located; or 

15 ‘‘(B) a third-party accreditation or inspec16 tion service approved by the Secretary. 

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

18 under paragraph (2) shall include requirements to 

19 prohibit a person from receiving or maintaining li20 censure for wholesale distribution if the person— 

21 ‘‘(A) has been convicted of any felony for 

22 conduct relating to wholesale distribution; any 

23 felony violation of section 301(i) or 301(k); or 

24 any felony violation of section 1365 of title 18, 


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1 United States Code, relating to prescription 

2 drug product tampering; or 

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

4 the requirements of this section that presents a 

5 threat of serious adverse health consequences or 

6 death to humans. 

7 ‘‘(b) REPORTING BY LICENSED WHOLESALE DIS8 TRIBUTORS.— 

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

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

11 section, each person engaged in wholesale distribu12 tion in interstate commerce shall submit on an an13 nual basis, and update as necessary, a report to the 

14 Secretary including— 

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

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

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

18 wholesale distributor is licensed for wholesale 

19 distribution; and 

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

21 State, the Federal Government, or a foreign 

22 government during the reporting period against 

23 the wholesale distributor. 

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

25 shall post on the public Internet Website of the 


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1 Food and Drug Administration the name of each 

2 wholesale distributor, and the State in which each 

3 such distributor is licensed, based on reports under 

4 paragraph (1). 

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

6 subchapter does not prohibit a State from— 

7 ‘‘(1) licensing wholesale distributors for the 

8 conduct of wholesale distribution activities in the 

9 State in accordance with this subchapter; and 

10 ‘‘(2) collecting fees from wholesale distributors 

11 in connection with such licensing, 

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

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

14 logistics provider activities. 

15 ‘‘(d) DEFINITION.—In this section, the term ‘whole16 sale distribution’ means the distribution of a drug subject 

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

18 or patient, but does not include— 

19 ‘‘(1) intracompany distribution of any drug be20 tween members of an affiliated group (as defined in 

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

22 1986); 

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

24 distribute a drug among hospitals or other health 

25 care entities which are under common control; 


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

2 distribute a drug for emergency medical reasons, in3 cluding a public health emergency declaration pursu4 ant to section 319 of the Public Health Service Act, 

5 except that a drug shortage not caused by a public 

6 health emergency shall not constitute such an emer7 gency medical reason; 

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

9 prescription executed in accordance with subsection 

10 503(b)(1); 

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

12 drug by a licensed retail pharmacy to a licensed 

13 practitioner for office use; 

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

15 distribute a drug by a charitable organization to a 

16 nonprofit affiliate of the organization to the extent 

17 otherwise permitted by law; 

18 ‘‘(7) the purchase or other acquisition by a dis19 penser, hospital, or other health care entity of a 

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

21 health care entity; 

22 ‘‘(8) the distribution of a drug by the manufac23 turer of such drug; 

24 ‘‘(9) the receipt or transfer of a drug by an au25 thorized third-party logistics provider provided that 


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1 such third-party logistics provider does not take 

2 ownership of the drug; 

3 ‘‘(10) the transport of a drug by a common car4 rier, provided that the common carrier does not take 

5 ownership of the drug; 

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

7 distribute a drug, by an authorized repackager that 

8 has taken ownership of the drug and repacked it in 

9 accordance with section 582(e); 

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

11 a dispenser in accordance with section 203.23 of 

12 title 21, Code of Federal Regulations (or any suc13 cessor regulation); 

14 ‘‘(13) the distribution of a combination pre15 scription drug product described in section 

16 581(20)(B)(xiii); 

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

18 kit described in section 581(21)(B)(xiv); 

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

20 that, by its formulation, is intended for the replen21 ishment of fluids and electrolytes (such as sodium, 

22 chloride, and potassium) or calories (such as dex23 trose and amino acids); 


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

2 used to maintain the equilibrium of water and min3 erals in the body, such as dialysis solutions; 

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

5 for irrigation or reconstitution, or sterile water, 

6 whether intended for such purposes or for injection; 

7 ‘‘(18) the distribution of compressed medical 

8 gas (as defined in section 581(21)(C)); or 

9 ‘‘(19) facilitating the distribution of a prescrip10 tion drug product by providing administrative serv11 ices, such as processing of orders and payments, 

12 without physical handling, distribution, or storage of 

13 a prescription drug product. 

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

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

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

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

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

19 Act.’’. 

20 (b) CONFORMING AMENDMENT.—Section 

21 804(a)(5)(A) of the Federal Food, Drug, and Cosmetic 

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

23 ‘‘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 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00086 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH 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— 

21 (1) by striking ‘‘or’’ after ‘‘the requirements of 

22 section 503(d)’’; and 

23 (2) by striking ‘‘or the distribution of drugs in 

24 violation of section 503(e) or the failure to otherwise 

25 comply with the requirements of section 503(e)’’ and 


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1 inserting ‘‘the failure to comply with any require2 ment of section 582, engaging in the wholesale dis3 tribution of a drug in violation of section 583 or the 

4 failure to otherwise comply with the requirements of 

5 section 583, or engaging in the activities of a third6 party logistics provider in violation of section 584 or 

7 the failure to otherwise comply with the require8 ments of section 584’’. 

9 (b) ENHANCED PENALTY FOR KNOWING UNLI10 CENSED ACTIVITIES.—Section 303(b)(1)(D) of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

12 333(b)(1)(D)) is amended by striking ‘‘503(e)(2)(A)’’ and 

13 inserting ‘‘583 or 584’’. 

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

15 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend16 ed by adding at the end the following: 

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

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

19 SEC. 7. UNIFORM NATIONAL POLICY. 

20 Subchapter H of chapter V of the Federal Food, 

21 Drug, and Cosmetic Act, as amended by section 5, is fur22 ther amended by adding at the end the following: 

23 ‘‘SEC. 585. UNIFORM NATIONAL POLICY. 

24 ‘‘(a) PREEMPTION OF STATE PRESCRIPTION DRUG

25 PRODUCT TRACING AND OTHER REQUIREMENTS.—BeVerDate Mar 15 2010 22:01 May 13, 2013 Jkt 029200 PO 00000 Frm 00092 Fmt 6652 Sfmt 6201 E:\BILLS\H1919.IH H1919

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1 ginning on the date of the enactment of the Safeguarding 

2 America’s Pharmaceuticals Act of 2013, no State or polit3 ical subdivision of a State may establish or continue in 

4 effect any requirements for tracing drugs through the dis5 tribution system (including any requirements with respect 

6 to paper or electronic pedigrees, track and trace, state7 ments of distribution history, transaction history, or 

8 transaction statements, or verification, investigation, dis9 position, alerts, or recordkeeping relating to the pharma10 ceutical distribution supply chain system) that— 

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

12 or in addition to any requirements applicable under 

13 this Act; or 

14 ‘‘(2) are inconsistent with any applicable waiv15 er, exception, or exemption issued by the Secretary 

16 under section 582(a). 

17 ‘‘(b) STANDARDS OR LICENSURE.— 

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

19 the enactment of Safeguarding America’s Pharma20 ceuticals Act of 2013, no State or political subdivi21 sion of a State may establish or continue any stand22 ards, requirements, or regulations with respect to 

23 wholesale drug distributor or third-party logistics 

24 provider licensure which are inconsistent with, less 

25 stringent than, in addition to, or more stringent 


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1 than, the standards and requirements under this 

2 Act. 

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

4 not affect the authority of a State to collect fees 

5 from wholesale drug distributors or third-party logis6 tics providers in connection with State licensing 

7 under section 583 or 584 pursuant to a licensing 

8 program meeting the requirements of such sections. 

9 ‘‘(3) ENFORCEMENT, SUSPENSION, AND REV10 OCATION OF LICENSES.—Notwithstanding paragraph 

11 (1), a State— 

12 ‘‘(A) may take administrative action, in13 cluding fines, to enforce a licensure requirement 

14 promulgated by the State in accordance with 

15 this Act; 

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

17 revocation of licenses issued by the State for 

18 violations of the laws of such State; 

19 ‘‘(C) upon conviction of a person for a vio20 lation of Federal, State, or local controlled sub21 stance laws or regulations, may provide for 

22 fines, imprisonment, or civil penalties; and 

23 ‘‘(D) may regulate activities of entities li24 censed pursuant to section 583 or 584 in a 


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1 manner that is consistent with the provisions of 

2 this subchapter.’’. 

3 SEC. 8. ELECTRONIC LABELING REQUIREMENT. 

4 Section 502(f) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 352(f)) is amended by adding at the 

6 end the following new sentence: ‘‘Required labeling, other 

7 than immediate container or carton labels, for a drug may 

8 be made available by manufacturers and distributors solely 

9 by electronic means, provided that the labeling complies 

10 with all applicable requirements of law and the manufac11 turer or distributor, as applicable, affords health care pro12 fessionals and authorized dispensers (as defined in section 

13 581) the opportunity to request the labeling in paper form, 

14 and after such request, promptly provides the requested 

15 information without additional cost.’’. 

Æ 


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