IB 

Union Calendar No. 65 

113TH CONGRESS 

1ST SESSION H. R. 1919 

[Report No. 113–93] 

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 

JUNE 3, 2013 

Additional sponsors: Mr. OLSON, Mr. LONG, Mr. LATHAM, Mr. VALADAO, Mr. 

RUSH, Mr. VEASEY, Mr. WALBERG, and Mrs. WALORSKI

JUNE 3, 2013 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on May 9, 2013] 

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A BILL 

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

respect to the pharmaceutical distribution supply chain, 

and for other purposes. 

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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 this 

7 Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Pharmaceutical distribution supply chain. 

Sec. 3. Enhanced drug distribution security. 

Sec. 4. National standards for wholesale distributors. 

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

Sec. 6. Penalties. 

Sec. 7. Uniform national policy. 

Sec. 8 Electronic labeling. 

8 SEC. 2. PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN. 

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

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

11 end the following: 

12 ‘‘Subchapter H—Pharmaceutical Distribution 

13 Supply Chain 

14 ‘‘SEC. 581. DEFINITIONS. 

15 ‘‘In this subchapter: 

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

17 means— 

18 ‘‘(A) in the case of a manufacturer or re19 packager, having a valid registration in accord20 ance with section 510; and 

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

2 third-party logistics provider, or dispenser, li3 censed (as defined in this section). 

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

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

6 retail pharmacy, hospital pharmacy, a group of 

7 chain pharmacies under common ownership and 

8 control, or any other person authorized by law to 

9 dispense or administer prescription drugs, to the 

10 extent such pharmacy, group, or person does not 

11 act as a wholesale distributor; 

12 ‘‘(B) includes warehouses and distribution 

13 centers under common ownership or control of 

14 entities described in subparagraph (A) that are 

15 members of an affiliated group pursuant to sec16 tion 1504(a) of the Internal Revenue Code of 

17 1986, to the extent such warehouses and distribu18 tion centers do not act as a wholesale distributor; 

19 and 

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

21 dispenses prescription drug product to be used in 

22 animals in accordance with section 512(a)(5). 

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

24 respect to a prescription drug product within the pos25 session and control of an entity— 

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1 ‘‘(A) means the removal of such prescription 

2 drug product, or taking measures to prevent the 

3 introduction of such prescription drug product, 

4 from the pharmaceutical distribution supply 

5 chain; and 

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

7 prescription drug product for disposal, or other 

8 appropriate handling and other actions such as 

9 retaining a sample of the prescription drug 

10 product for additional physical examination or 

11 laboratory analysis by a manufacturer or regu12 latory or law enforcement agency. 

13 ‘‘(4) DISTRIBUTE OR DISTRIBUTION.—The terms 

14 ‘distribute’ and ‘distribution’ mean the sale, purchase, 

15 trade, delivery, handling, or storage of a prescription 

16 drug product. 

17 ‘‘(5) ILLEGITIMATE PRESCRIPTION DRUG PROD18 UCT.—The term ‘illegitimate prescription drug prod19 uct’ means a prescription drug product which a man20 ufacturer has confirmed— 

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

22 ‘‘(B) is intentionally adulterated such that 

23 the prescription drug product would result in se24 rious adverse health consequences or death to hu25 mans; or 

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1 ‘‘(C) is otherwise unfit for distribution such 

2 that the prescription drug product is reasonably 

3 likely to cause serious adverse human health con4 sequences or death. 

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

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

7 having a valid license to make wholesale dis8 tributions consistent with the standards under 

9 section 583; 

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

11 provider, having a valid license to engage in the 

12 activities of a third-party logistics provider in 

13 accordance with section 584; and 

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

15 valid license to dispense prescription drugs 

16 under State law. 

17 ‘‘(7) MANUFACTURER.—The term ‘manufacturer’ 

18 means, with respect to a prescription drug product— 

19 ‘‘(A) a person that holds an application ap20 proved under section 505 or a license issued 

21 under section 351 of the Public Health Service 

22 Act for such prescription drug product, or if such 

23 prescription drug product is not the subject of an 

24 approved application or license, the person who 

25 manufactured the prescription drug product; 

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1 ‘‘(B) a co-licensed partner of the person de2 scribed in subparagraph (A) that obtains the 

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

5 ‘‘(C) a person that— 

6 ‘‘(i) is a member of an affiliated group 

7 (as defined in section 1504(a) of the Inter8 nal Revenue Code of 1986) to which a per9 son described in subparagraph (A) or (B) is 

10 also a member; and 

11 ‘‘(ii) receives the prescription drug 

12 product directly from a person described in 

13 subparagraph (A) or (B). 

14 ‘‘(8) PACKAGE.— 

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

16 means the smallest individual saleable unit of 

17 prescription drug product for distribution in 

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

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

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

23 term ‘individual saleable unit’ means the small24 est container of prescription drug product intro25 duced into interstate commerce by the manufacmstockstill on DSK4VPTVN1PROD with BILLS

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1 turer or repackager that is intended by the man2 ufacturer for individual sale to a dispenser. 

3 ‘‘(9) PRESCRIPTION DRUG.—The term ‘prescrip4 tion drug’ means a drug for human use subject to sec5 tion 503(b)(1). 

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

7 ‘prescription drug product’ means a prescription drug 

8 in a finished dosage form for administration to a pa9 tient without substantial further manufacturing (such 

10 as capsules, tablets, and lyophilized prescription drug 

11 products before reconstitution). 

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

15 ‘‘(A) includes the standardized numerical 

16 identifier, lot number, and expiration date of a 

17 prescription drug product; and 

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

19 on a machine-readable data carrier that con20 forms to the standards developed by a widely rec21 ognized international standards development or22 ganization. 

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

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

25 of preventing distribution or transfer of the product, 

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1 in a physically separate area clearly identified for 

2 such use, or through use of other procedures such as 

3 automated designation. 

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

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

7 product or package for further sale or distribution. 

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

10 trading partner or trading partners from which such 

11 prescription drug product was purchased or received, 

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

14 ‘‘(15) RETURNS PROCESSOR.—The terms ‘returns 

15 processor’ mean a person who owns or operates an es16 tablishment that provides for the disposition of or oth17 erwise processes saleable and nonsaleable prescription 

18 drug product received from an authorized trading 

19 partner such that the prescription drug product may 

20 be processed for credit to the purchaser, manufacturer, 

21 seller, or disposed of for no further distribution. 

22 ‘‘(16) SPECIFIC PATIENT NEED.—The term ‘spe23 cific patient need’— 

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

25 a prescription drug product from one pharmacy 

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1 to another, to fill a prescription for an identified 

2 patient; and 

3 ‘‘(B) does not include the transfer of a pre4 scription drug product from one pharmacy to 

5 another for the purpose of increasing or replen6 ishing stock in anticipation of a potential need. 

7 ‘‘(17) STANDARDIZED NUMERICAL IDENTIFIER.— 

8 The term ‘standardized numerical identifier’ means a 

9 set of numbers or characters that— 

10 ‘‘(A) is used to uniquely identify each pack11 age or homogenous case of the prescription drug 

12 product; and 

13 ‘‘(B) is composed of the National Drug Code 

14 that corresponds to the specific prescription drug 

15 product (including the particular package con16 figuration) combined with a unique alpha17 numeric serial number of up to 20 characters. 

18 ‘‘(18) SUSPECT PRESCRIPTION DRUG PROD19 UCT.—The term ‘suspect prescription drug product’ 

20 means a prescription drug product for which there is 

21 reason to believe that such prescription drug prod22 uct— 

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

24 stolen; 

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1 ‘‘(B) is potentially intentionally adulterated 

2 such that the prescription drug product would 

3 result in serious adverse health consequences or 

4 death to humans; or 

5 ‘‘(C) appears otherwise unfit for distribu6 tion such that the prescription drug product 

7 would result in serious adverse health con8 sequences or death to humans. 

9 ‘‘(19) THIRD-PARTY LOGISTICS PROVIDER.—The 

10 term ‘third-party logistics provider’ means an entity 

11 that provides or coordinates warehousing, distribu12 tion, or other logistics services of a prescription drug 

13 product in interstate commerce on behalf of a manu14 facturer, wholesale distributor, or dispenser of a pre15 scription drug product, but does not take ownership 

16 of the prescription drug product, nor have responsi17 bility to direct the sale or disposition of, the prescrip18 tion drug product. 

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

20 partner’ means— 

21 ‘‘(A) a manufacturer, repackager, wholesale 

22 distributor, or dispenser from whom a manufac23 turer, repackager, wholesale distributor, or dis24 penser accepts ownership of a prescription drug 

25 product or to whom a manufacturer, repackager, 

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1 wholesale distributor, or dispenser transfers own2 ership of a prescription drug product; or 

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

4 whom a manufacturer, repackager, wholesale dis5 tributor, or dispenser accepts possession of a pre6 scription drug product or to whom a manufac7 turer, repackager, wholesale distributor, or dis8 penser transfers possession of a prescription drug 

9 product. 

10 ‘‘(21) TRANSACTION.— 

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

12 means the transfer in interstate commerce of pre13 scription drug product between persons in which 

14 a change of ownership occurs. 

15 ‘‘(B) EXEMPTIONS.—The term ‘transaction’ 

16 does not include— 

17 ‘‘(i) intracompany distribution of any 

18 prescription drug product, including be19 tween members of an affiliated group (as 

20 defined in section 1504(a) of the Internal 

21 Revenue Code of 1986); 

22 ‘‘(ii) the distribution of a prescription 

23 drug product among hospitals or other 

24 health care entities that are under common 

25 control; 

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1 ‘‘(iii) the distribution of a prescription 

2 drug product for emergency medical reasons 

3 including a public health emergency dec4 laration pursuant to section 319 of the Pub5 lic Health Service Act, except that a drug 

6 shortage not caused by a public health 

7 emergency shall not constitute an emergency 

8 medical reason; 

9 ‘‘(iv) the dispensing of a prescription 

10 drug product pursuant to a valid prescrip11 tion executed in accordance with section 

12 503(b)(1); 

13 ‘‘(v) the distribution of prescription 

14 drug product samples by a manufacturer or 

15 a licensed wholesale distributor in accord16 ance with section 503(d); 

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

18 components intended for transfusion; 

19 ‘‘(vii) the distribution of minimal 

20 quantities of prescription drug product by a 

21 licensed retail pharmacy to a licensed prac22 titioner for office use; 

23 ‘‘(viii) the distribution of a prescrip24 tion drug product by a charitable organiza25 tion to a nonprofit affiliate of the organizamstockstill on DSK4VPTVN1PROD with BILLS

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1 tion to the extent otherwise permitted by 

2 law; 

3 ‘‘(ix) the distribution of a prescription 

4 drug product pursuant to the sale or merger 

5 of a pharmacy or pharmacies or a wholesale 

6 distributor or wholesale distributors, except 

7 that any records required to be maintained 

8 for the prescription drug product shall be 

9 transferred to the new owner of the phar10 macy or pharmacies or wholesale dis11 tributor or wholesale distributors; 

12 ‘‘(x) the dispensing of a prescription 

13 drug product approved under section 

14 512(b); 

15 ‘‘(xi) the transfer of prescription drug 

16 products to or from any facility that is li17 censed by the Nuclear Regulatory Commis18 sion or by a State pursuant to an agree19 ment with such Commission under section 

20 274 of the Atomic Energy Act of 1954 (42 

21 U.S.C. 2021); 

22 ‘‘(xii) the distribution of a combina23 tion product that consists of— 

24 ‘‘(I) a product comprised of two 

25 or more components that are each a 

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1 drug, biological product, or device and 

2 that are physically, chemically, or oth3 erwise combined or mixed and pro4 duced as a single entity; 

5 ‘‘(II) two or more separate prod6 ucts packaged together in a single 

7 package or as a unit and comprised of 

8 a drug and device or a device and bio9 logical product; or 

10 ‘‘(III) two or more finished de11 vices plus one or more drug or biologi12 cal products which are packaged to13 gether in a medical convenience kit de14 scribed in clause (xiv); 

15 ‘‘(xiii) the distribution of a medical 

16 convenience kit which is a collection of fin17 ished products (consisting of devices or 

18 drugs) assembled in kit form strictly for the 

19 convenience of the purchaser or user if— 

20 ‘‘(I) the medical convenience kit is 

21 assembled in an establishment that is 

22 registered with the Food and Drug Ad23 ministration as a medical device man24 ufacturer; 

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1 ‘‘(II) the person who manufactur2 ers the medical convenience kit pur3 chased the prescription drug product 

4 directly from the manufacturer or from 

5 a wholesale distributor that purchased 

6 the prescription drug product directly 

7 from the manufacturer; 

8 ‘‘(III) the person who manufac9 turers the medical convenience kit does 

10 not alter the primary container or 

11 label of the prescription drug product 

12 as purchased from the manufacturer or 

13 wholesale distributor; 

14 ‘‘(IV) the medical convenience kit 

15 does not contain a controlled substance 

16 (as defined in section 102 of the Con17 trolled Substances Act); and 

18 ‘‘(V) the prescription drug prod19 ucts contained in the medical conven20 ience kit are— 

21 ‘‘(aa) intravenous solutions 

22 intended for the replenishment of 

23 fluids and electrolytes; 

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1 ‘‘(bb) drugs intended to 

2 maintain the equilibrium of water 

3 and minerals in the body; 

4 ‘‘(cc) drugs intended for irri5 gation or reconstitution; 

6 ‘‘(dd) anesthetics; 

7 ‘‘(ee) anticoagulants; 

8 ‘‘(ff) vasopressors; or 

9 ‘‘(gg) sympathicomimetics; 

10 ‘‘(xiv) the distribution of an intra11 venous prescription drug product that, by 

12 its formulation, is intended for the replen13 ishment of fluids and electrolytes (such as 

14 sodium, chloride, and potassium) or calories 

15 (such as dextrose and amino acids); 

16 ‘‘(xv) the distribution of an intra17 venous prescription drug product used to 

18 maintain the equilibrium of water and 

19 minerals in the body, such as dialysis solu20 tions; 

21 ‘‘(xvi) the distribution of a prescrip22 tion drug product that is intended for irri23 gation or reconstitution, or sterile water, 

24 whether intended for such purposes or for 

25 injection; 

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1 ‘‘(xvii) the distribution of compressed 

2 medical gas; or 

3 ‘‘(xviii)(I) the distribution of a product 

4 by a dispenser, or a wholesale distributor 

5 acting at the direction of the dispenser, to 

6 a repackager registered under section 510 

7 for the purpose of repackaging the drug for 

8 use by that dispenser or another health care 

9 entity that is under the dispenser’s owner10 ship or control, so long as the dispenser re11 tains ownership of the prescription drug 

12 product; and 

13 ‘‘(II) the saleable or nonsaleable return 

14 by such repackager of such prescription 

15 drug product. 

16 ‘‘(C) COMPRESSED MEDICAL GAS.—For 

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

18 ‘compressed medical gas’ means any substance in 

19 its gaseous or cryogenic liquid form that meets 

20 medical purity standards and has application in 

21 a medical or homecare environment, including 

22 oxygen and nitrous oxide. 

23 ‘‘(22) TRANSACTION HISTORY.—The term ‘trans24 action history’ means a statement that— 

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1 ‘‘(A) includes the transaction information 

2 for each transaction conducted with respect to a 

3 prescription drug product beginning with the 

4 manufacturer or initial purchase distributor for 

5 each prior transaction going back to the manu6 facturer of the prescription drug product or to 

7 the initial purchase distributor; and 

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

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

10 ‘transaction information’ means— 

11 ‘‘(A) the proprietary or established name or 

12 names of the prescription drug product; 

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

14 prescription drug product; 

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

16 prescription drug product; 

17 ‘‘(D) the container size; 

18 ‘‘(E) the number of containers; 

19 ‘‘(F) the lot number of the prescription drug 

20 product; 

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

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

23 person from whom ownership is being trans24 ferred; and 

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

2 person to whom ownership is being transferred. 

3 ‘‘(24) TRANSACTION STATEMENT.—The ‘trans4 action statement’ is a statement, which states that the 

5 manufacturer, repackager, wholesale distributor, 

6 third-party logistics provider, or dispenser transfer7 ring ownership in a transaction— 

8 ‘‘(A) is authorized; 

9 ‘‘(B) received transaction information and 

10 a transaction statement as required under sec11 tion 582 from the prior owner of the prescription 

12 drug product; 

13 ‘‘(C) did not knowingly and intentionally 

14 ship an illegitimate prescription drug product; 

15 ‘‘(D) did not knowingly and intentionally 

16 provide false transaction information; and 

17 ‘‘(E) did not knowingly and intentionally 

18 alter the transaction history. 

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

20 ‘verification’ and ‘verify’— 

21 ‘‘(A) mean determining whether the pre22 scription drug product identifier affixed to, or 

23 imprinted upon, a package or homogeneous case 

24 of the prescription drug product corresponds to 

25 the standardized numerical identifier or lot 

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1 number, and expiration date assigned to the pre2 scription drug product by the manufacturer or 

3 the repackager, as applicable; and 

4 ‘‘(B) include making the determination 

5 under subparagraph (A) using human-readable 

6 or machine-readable methods. 

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

8 ‘wholesale distributor’— 

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

10 distribution (as defined in section 583); and 

11 ‘‘(B) excludes— 

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

13 partner of a manufacturer, or a third-party 

14 logistics provider, or a dispenser who does 

15 not engage in such wholesale distribution; 

16 ‘‘(ii) a repackager engaged in such 

17 wholesale distribution; or 

18 ‘‘(iii) the distribution of prescription 

19 drug product or an offer to distribute pre20 scription drug product by an authorized re21 packager that has taken ownership or pos22 session of the prescription drug product and 

23 repacked the prescription drug product in 

24 accordance with the requirements of section 

25 582(e). 

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1 ‘‘SEC. 582. REQUIREMENTS. 

2 ‘‘(a) IN GENERAL.— 

3 ‘‘(1) COMPLIANCE REQUIRED.—An entity that is 

4 a manufacturer, repackager, wholesale distributor, 

5 third-party logistics provider, or dispenser shall com6 ply with the requirements of this section. If an entity 

7 meets the definition of more than one of the entities 

8 referred to in the preceding sentence, such entity shall 

9 comply with all applicable requirements of this sec10 tion, but shall not be required to comply with dupli11 cative requirements. 

12 ‘‘(2) STANDARDS.—The Secretary shall, in con13 sultation with other appropriate Federal officials, 

14 manufacturers, repackagers, wholesale distributors, 

15 third-party logistics providers, and dispensers, estab16 lish, by regulation, standards for the exchange of 

17 transaction information for purposes of complying 

18 with this section. The standards established under this 

19 paragraph shall be in accordance with a form devel20 oped by a widely recognized international standards 

21 development organization. In establishing such stand22 ards, the Secretary shall consider the feasibility of es23 tablishing standardized documentation to be used by 

24 all members of the pharmaceutical distribution sup25 ply chain to convey the transaction history and 

26 transaction statement to the subsequent owner of a 

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1 prescription drug product. The Secretary shall pub2 lish such standards not later than 180 days after the 

3 date of the enactment of the Safeguarding America’s 

4 Pharmaceuticals Act of 2013. 

5 ‘‘(3) WAIVERS, EXCEPTIONS, AND EXEMP6 TIONS.—Not later than one year after the date of the 

7 enactment of the Safeguarding America’s Pharma8 ceuticals Act of 2013, the Secretary shall promulgate 

9 a regulation to— 

10 ‘‘(A) establish a process by which the Sec11 retary may grant, at the request of an authorized 

12 manufacturer, repackager, wholesale distributor, 

13 or dispenser, a waiver from any of the require14 ments of this section— 

15 ‘‘(i) if the Secretary determines that 

16 such requirements would result in an undue 

17 economic hardship; or 

18 ‘‘(ii) for emergency medical reasons, 

19 including a public health emergency dec20 laration pursuant to section 319 of the Pub21 lic Health Service Act; 

22 ‘‘(B) establish a process, with respect to the 

23 prescription drug product identifier requirement 

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

25 and (e) through which— 

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1 ‘‘(i) a manufacturer or repackager 

2 may request a waiver with respect to pre3 scription drug products that are packaged 

4 in a container too small or otherwise unable 

5 to accommodate a label with sufficient space 

6 to bear the information required for compli7 ance with such requirement; and 

8 ‘‘(ii) the Secretary determines whether 

9 to waive such requirement; and 

10 ‘‘(C) establish a process by which the Sec11 retary may add the prescription drug products 

12 or transactions that are exempt from the require13 ments of this section. 

14 ‘‘(4) GRANDFATHERED PERSONS AND PRESCRIP15 TION DRUG PRODUCTS.— 

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

17 after the date of the enactment of the Safe18 guarding America’s Pharmaceuticals Act of 

19 2013, the Secretary shall specify, by regulation, 

20 whether and under what circumstances the pre21 scription drug product identifier requirement 

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

23 and (e) shall apply to a prescription drug prod24 uct that is in the supply chain or in a manufac25 turer’s inventory on the date of the enactment of 

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1 the Safeguarding America’s Pharmaceuticals Act 

2 of 2013. 

3 ‘‘(B) THIRD-PARTY LOGISTICS PROVIDER LI4 CENSES.—Until the date that is 1 year after the 

5 effective date of the third-party logistics provider 

6 licensing requirements under section 584, a 

7 third-party logistics provider shall be considered 

8 ‘licensed’ under section 581(6)(B) unless the Sec9 retary has made a finding that the third-party 

10 logistics provider does not utilize good handling 

11 and distribution practices and publishes notice 

12 thereof. 

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

14 package labels solely to incorporate the prescrip15 tion drug product identifier may be submitted to 

16 the Secretary in the annual report of an estab17 lishment, in accordance with section 314.70(d) of 

18 chapter 21, Code of Federal Regulations (or any 

19 successor regulation). 

20 ‘‘(b) MANUFACTURER REQUIREMENTS.— 

21 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRACING.— 

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

23 than January 1, 2015, a manufacturer shall— 

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

25 transaction in which such manufacturer 

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1 transfers ownership of a prescription drug 

2 product, provide the subsequent owner with 

3 the transaction history and a transaction 

4 statement; and 

5 ‘‘(ii) maintain the transaction infor6 mation for each such transaction for not 

7 less than 3 years after the date of the trans8 action. 

9 ‘‘(B) REQUESTS FOR INFORMATION.—Upon 

10 a request by the Secretary or other appropriate 

11 Federal or State official, in the event of a recall 

12 or for the purpose of investigating a suspect pre13 scription drug product or an illegitimate pre14 scription drug product, a manufacturer shall, 

15 not later than 2 business days after receiving the 

16 request or in such reasonable time as determined 

17 by the Secretary, provide to the Secretary or 

18 other official, the applicable transaction history 

19 and transaction statement for the prescription 

20 drug product. 

21 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI22 FIER.—Beginning not later than 5 years after the 

23 date of the enactment of the Safeguarding America’s 

24 Pharmaceuticals Act of 2013, a manufacturer shall 

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1 fier on each package and homogenous case of a pre2 scription drug product intended to be introduced in 

3 a transaction. Such manufacturer shall maintain the 

4 information in the prescription drug product identi5 fier for such prescription drug product for not less 

6 than 3 years after the date of the transaction. 

7 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Begin8 ning not later than January 1, 2015, a manufacturer 

9 shall ensure that each of its trading partners is au10 thorized. 

11 ‘‘(4) LIST OF AUTHORIZED DISTRIBUTORS OF

12 RECORD.—Beginning not later than January 1, 2015, 

13 each manufacturer of a prescription drug shall— 

14 ‘‘(A) maintain a list of the authorized dis15 tributors of record of such drug at the corporate 

16 offices of such manufacturer; 

17 ‘‘(B) make such list publicly available, in18 cluding placement on the Internet Website of 

19 such manufacturer; and 

20 ‘‘(C) update such list not less than once per 

21 quarter. 

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

23 January 1, 2015, a manufacturer shall implement 

24 systems and processes to enable the manufacturer to 

25 comply with the following requirements: 

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1 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD2 UCT.— 

3 ‘‘(i) IN GENERAL.—Upon making a de4 termination that a prescription drug prod5 uct in the possession or control of the manu6 facturer is a suspect prescription drug 

7 product, or upon receiving a request for 

8 verification from the Secretary that a pre9 scription drug product within the possession 

10 or control of a manufacturer is a suspect 

11 prescription drug product, a manufacturer 

12 shall promptly conduct an investigation in 

13 coordination with trading partners, as ap14 plicable, to determine whether the prescrip15 tion drug product is an illegitimate pre16 scription drug product. Beginning not later 

17 than 5 years after the date of the enactment 

18 of the Safeguarding America’s Pharma19 ceuticals Act of 2013, such investigation 

20 shall include— 

21 ‘‘(I) verifying the prescription 

22 drug product at the package level; 

23 ‘‘(II) validating any applicable 

24 transaction history in the possession of 

25 the manufacturer; and 

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1 ‘‘(III) otherwise investigating to 

2 determine whether the prescription 

3 drug product is an illegitimate pre4 scription drug product. 

5 ‘‘(ii) CLEARED PRESCRIPTION DRUG

6 PRODUCT.—If the manufacturer determines 

7 that a suspect prescription drug product is 

8 not an illegitimate prescription drug prod9 uct, the manufacturer shall promptly notify 

10 the Secretary of such determination and 

11 such prescription drug product may be fur12 ther distributed. 

13 ‘‘(iii) RECORDS.—A manufacturer 

14 shall keep records of its investigation of a 

15 suspect prescription drug product for not 

16 less than 3 years after the conclusion of the 

17 investigation. 

18 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

19 PRODUCT.— 

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

21 that a prescription drug product in the pos22 session or control of a manufacturer is an 

23 illegitimate prescription drug product, the 

24 manufacturer shall— 

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1 ‘‘(I) quarantine such prescription 

2 drug product from prescription drug 

3 product intended for distribution; and 

4 ‘‘(II) provide for the disposition of 

5 the illegitimate prescription drug prod6 uct. 

7 ‘‘(ii) TRADING PARTNER.—Upon deter8 mining that a prescription drug product in 

9 the possession or control of a trading part10 ner is an illegitimate prescription drug 

11 product, the manufacturer shall take reason12 able steps to assist a trading partner to pro13 vide for the disposition of the illegitimate 

14 prescription drug product. 

15 ‘‘(iii) MAKING A NOTIFICATION.—Upon 

16 determining that a prescription drug prod17 uct in the possession or control of the manu18 facturer is an illegitimate prescription drug 

19 product, the manufacturer shall notify the 

20 Secretary of such determination not later 

21 than 24 hours after making such determina22 tion. The Secretary shall determine whether 

23 additional trading partner notification is 

24 appropriate. 

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1 ‘‘(iv) RESPONDING TO A NOTIFICA2 TION.—Upon the receipt of a notification 

3 from the Secretary that a determination has 

4 been made that a prescription drug product 

5 is an illegitimate prescription drug product, 

6 a manufacturer shall— 

7 ‘‘(I) identify all illegitimate pre8 scription drug products that are sub9 ject to such notification and in the pos10 session or control of the manufacturer, 

11 including any prescription drug prod12 uct that is subsequently received; and 

13 ‘‘(II) perform the activities de14 scribed in clause (i). 

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

16 keep records of the disposition of an illegit17 imate prescription drug product for not less 

18 than 3 years after the conclusion of the dis19 position. 

20 ‘‘(C) ELECTRONIC DATABASE.—A manufac21 turer may satisfy the requirements of this para22 graph through the use of a secure electronic data23 base developed and operated by the manufacturer 

24 or another entity. The owner of such database 

25 shall establish the requirements and processes to 

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•HR 1919 RH

1 respond to requests and may provide for data ac2 cess to other members of the pharmaceutical dis3 tribution supply chain, as appropriate. The de4 velopment and operation of such a database shall 

5 not relieve a manufacturer of the requirement 

6 under this paragraph to respond to a 

7 verification request submitted by means other 

8 than a secure electronic database. 

9 ‘‘(D) RETURNED PRESCRIPTION DRUG

10 PRODUCT.—Beginning not later than 5 years 

11 after the date of the enactment of the Safe12 guarding America’s Pharmaceuticals Act of 

13 2013, upon receipt of a returned prescription 

14 drug product that the manufacturer intends to 

15 further distribute, before further distributing 

16 such prescription drug product, the manufac17 turer shall— 

18 ‘‘(i) verify the prescription drug prod19 uct identifier for each sealed homogeneous 

20 case of such prescription drug product; or 

21 ‘‘(ii) if such prescription drug product 

22 is not in a sealed homogeneous case, verify 

23 the prescription drug product identifier on 

24 each package. 

25 ‘‘(c) WHOLESALE DISTRIBUTOR REQUIREMENTS.— 

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•HR 1919 RH

1 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRACING.— 

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

3 than April 1, 2015, a wholesale distributor 

4 shall— 

5 ‘‘(i) not accept ownership of a pre6 scription drug product unless the previous 

7 owner prior to, or at the time of, the trans8 action provides the applicable transaction 

9 history and a transaction statement for the 

10 prescription drug product; 

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

12 transaction in which the wholesale dis13 tributor transfers ownership of a prescrip14 tion drug product— 

15 ‘‘(I) in the case that the wholesale 

16 distributor purchased the prescription 

17 drug product directly from the manu18 facturer, provide the subsequent owner 

19 with transaction history and a trans20 action statement for the prescription 

21 drug product; or 

22 ‘‘(II) in the case that the whole23 sale distributor did not purchase the 

24 prescription drug product directly 

25 from the manufacturer, the exclusive 

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•HR 1919 RH

1 distributor of the manufacturer, or a 

2 repackager that purchased directly 

3 from the manufacturer, provide the 

4 subsequent owner with transaction his5 tory beginning with the wholesale dis6 tributor that did purchase the product 

7 directly from the manufacturer, the ex8 clusive distributor of the manufacturer, 

9 or a repackager that purchased directly 

10 from the manufacturer; 

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

12 the wholesale distributor purchased the pre13 scription drug product directly from the 

14 manufacturer, its exclusive distributor, or a 

15 repackager that purchased directly from the 

16 manufacturer or its authorized distributor 

17 of record— 

18 ‘‘(I) provide an initial purchase 

19 transaction statement on the invoice to 

20 the customer, stating that the wholesale 

21 distributor purchased the prescription 

22 drug product package directly from the 

23 manufacturer, exclusive distributor, or 

24 repackager; 

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•HR 1919 RH

1 ‘‘(II) make available to the imme2 diate subsequent recipient of such pre3 scription drug product the information 

4 required under clause (ii) through any 

5 combination of self-generated paper, 

6 electronic data, or manufacturer-pro7 vided information on the prescription 

8 drug product package; and 

9 ‘‘(III) for purposes of subclauses 

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

11 transactions occurring before the trans12 fer of the prescription drug product to 

13 the wholesale distributor; and 

14 ‘‘(iv) maintain the transaction infor15 mation for each transaction described in 

16 clauses (i) and (ii) for not less than 3 years 

17 after the transaction. 

18 ‘‘(B) RETURNS EXCEPTION.— 

19 ‘‘(i) SALEABLE RETURNS.—Notwith20 standing subparagraph (A), a wholesale dis21 tributor may— 

22 ‘‘(I) accept returned prescription 

23 drug product without a transaction 

24 history from a dispenser or repackager; 

25 and 

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•HR 1919 RH

1 ‘‘(II) distribute such returned pre2 scription drug product with a trans3 action history that begins with the 

4 wholesale distributor that so accepted 

5 the returned product. 

6 ‘‘(ii) NONSALEABLE RETURNS.—A 

7 wholesale distributor may return a nonsale8 able prescription drug to the manufacturer 

9 or repackager, to the wholesale distributor 

10 from whom such prescription drug was pur11 chased, or to a person acting on behalf of 

12 such a person, including a returns proc13 essor, without providing the information re14 quired under subparagraph (A). 

15 ‘‘(C) REQUESTS FOR INFORMATION.—Upon 

16 a request by the Secretary or other appropriate 

17 Federal or State official, in the event of a recall 

18 or for the purpose of investigating a suspect pre19 scription drug product or an illegitimate pre20 scription drug product a wholesale distributor 

21 shall, not later than 2 business days after receiv22 ing the request or in such other reasonable time 

23 as determined by the Secretary, provide the ap24 plicable transaction history and transaction 

25 statements for the prescription drug product. 

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•HR 1919 RH

1 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI2 FIER.—Beginning not later than 7 years after the 

3 date of the enactment of the Safeguarding America’s 

4 Pharmaceuticals Act of 2013, a wholesale distributor 

5 may engage in transactions involving a prescription 

6 drug product only if such prescription drug product 

7 is encoded with a prescription drug product identi8 fier, except as provided in subsection (a)(4). 

9 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Begin10 ning not later than January 1, 2015, a wholesale dis11 tributor shall ensure that each of its trading partners 

12 is authorized. 

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

14 April 1, 2015, a wholesale distributor shall implement 

15 systems to enable the wholesale distributor to comply 

16 with the following requirements: 

17 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD18 UCT.— 

19 ‘‘(i) IN GENERAL.—Upon making a de20 termination that a prescription drug prod21 uct in the possession or control of the whole22 sale distributor is a suspect prescription 

23 drug product, or upon receiving a request 

24 for verification from the Secretary that a 

25 prescription drug product within the possesmstockstill on DSK4VPTVN1PROD with BILLS

38 

•HR 1919 RH

1 sion or control of a wholesale distributor is 

2 a suspect prescription drug product, a 

3 wholesale distributor shall promptly conduct 

4 an investigation to determine whether the 

5 prescription drug product is an illegitimate 

6 prescription drug product. Beginning not 

7 later than 7 years after the date of the en8 actment of the Safeguarding America’s 

9 Pharmaceuticals Act of 2013, such inves10 tigation shall include— 

11 ‘‘(I) verifying a package of the 

12 prescription drug product; 

13 ‘‘(II) validating any applicable 

14 transaction history in the possession of 

15 the wholesale distributor; and 

16 ‘‘(III) otherwise investigating to 

17 determine whether the prescription 

18 drug product is an illegitimate pre19 scription drug product. 

20 ‘‘(ii) CLEARED PRESCRIPTION DRUG

21 PRODUCT.—If the wholesale distributor de22 termines that a suspect prescription drug 

23 product is not an illegitimate prescription 

24 drug product, the wholesale distributor shall 

25 promptly notify the Secretary of such determstockstill on DSK4VPTVN1PROD with BILLS

39 

•HR 1919 RH

1 mination and such prescription drug prod2 uct may be further distributed. 

3 ‘‘(iii) RECORDS.—A wholesale dis4 tributor shall keep records of its investiga5 tion of a suspect prescription drug product 

6 for not less than 3 years after the conclusion 

7 of the investigation. 

8 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

9 PRODUCT.— 

10 ‘‘(i) IN GENERAL.—Upon receiving no11 tice that a manufacturer of a prescription 

12 drug product has determined that a pre13 scription drug product in the possession or 

14 control of a wholesale distributor is an ille15 gitimate prescription drug product, the 

16 wholesale distributor shall— 

17 ‘‘(I) quarantine such prescription 

18 drug product within the possession or 

19 control of the wholesale distributor 

20 from prescription drug product in21 tended for distribution; and 

22 ‘‘(II) provide for the disposition of 

23 the illegitimate prescription drug prod24 uct within the possession or control of 

25 the wholesale distributor. 

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•HR 1919 RH

1 ‘‘(ii) TRADING PARTNER.—Upon deter2 mining that a prescription drug product in 

3 the possession or control of a trading part4 ner is an illegitimate prescription drug 

5 product, the wholesale distributor shall take 

6 reasonable steps to assist a trading partner 

7 to provide for the disposition of the illegit8 imate prescription drug product. 

9 ‘‘(iii) MAKING A NOTIFICATION.—Upon 

10 determining that a prescription drug prod11 uct in the possession or control of the whole12 sale distributor is an illegitimate prescrip13 tion drug product, the wholesale distributor 

14 shall notify the Secretary of such deter15 mination not later than 24 hours after 

16 making such determination. The Secretary 

17 shall determine whether additional trading 

18 partner notification is appropriate. 

19 ‘‘(iv) RESPONDING TO A NOTIFICA20 TION.—Upon the receipt of a notification 

21 from the Secretary that a determination has 

22 been made that a prescription drug product 

23 is an illegitimate prescription drug product, 

24 a wholesale distributor shall— 

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•HR 1919 RH

1 ‘‘(I) identify all illegitimate pre2 scription drug product subject to such 

3 notification that is in the possession or 

4 control of the wholesale distributor, in5 cluding any prescription drug product 

6 that is subsequently received; and 

7 ‘‘(II) perform the activities de8 scribed in clause (i). 

9 ‘‘(v) RECORDS.—A wholesale dis10 tributor shall keep records of the disposition 

11 of an illegitimate prescription drug product 

12 for not less than 3 years after the conclusion 

13 of the disposition. 

14 ‘‘(C) ELECTRONIC DATABASE.—A wholesale 

15 distributor may satisfy the requirements of this 

16 paragraph through the use of a secure electronic 

17 database developed and operated by the manu18 facturer or another entity. The owner of such 

19 database shall establish the requirements and 

20 processes to respond to requests and may provide 

21 for data access to other members of the pharma22 ceutical distribution supply chain, as appro23 priate. The development and operation of such a 

24 database shall not relieve a wholesale distributor 

25 of the requirement under this paragraph to remstockstill on DSK4VPTVN1PROD with BILLS

42 

•HR 1919 RH

1 spond to a verification request submitted by 

2 means other than a secure electronic database. 

3 ‘‘(D) RETURNED PRESCRIPTION DRUG

4 PRODUCT.—Beginning not later than 7 years 

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

7 2013, upon receipt of a returned prescription 

8 drug product that the wholesale distributor in9 tends to further distribute, before further distrib10 uting such prescription drug product, the whole11 sale distributor shall— 

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

14 case of such prescription drug product; or 

15 ‘‘(ii) if such prescription drug product 

16 is not in a sealed homogeneous case, verify 

17 the prescription drug product identifier on 

18 each package. 

19 ‘‘(d) DISPENSER REQUIREMENTS.— 

20 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRACING.— 

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

22 than July 1, 2015, a dispenser— 

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

24 prescription drug product, unless the pre25 vious owner prior to, or at the time of, the 

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•HR 1919 RH

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 transfers 

5 ownership of a prescription drug product 

6 (but not including dispensing to a patient 

7 or returns) shall provide the subsequent 

8 owner with transaction history and a trans9 action statement for the prescription drug 

10 product, except that the requirements of this 

11 clause shall not apply to sales by a dis12 penser to another dispenser to fulfill a spe13 cific patient need; and 

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

16 after the date of the transaction. 

17 ‘‘(B) AGREEMENTS WITH THIRD PARTIES.— 

18 A dispenser may enter into a written agreement 

19 with a third party, including an authorized 

20 wholesale distributor, under which the third 

21 party confidentially maintains the transaction 

22 information required to be maintained under 

23 this subsection on behalf of the dispenser. If a 

24 dispenser enters into such an agreement, the dismstockstill on DSK4VPTVN1PROD with BILLS

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•HR 1919 RH

1 penser shall maintain a copy of the written 

2 agreement. 

3 ‘‘(C) RETURNS EXCEPTION.— 

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

6 may return prescription drug product to the 

7 trading partner from which the dispenser 

8 obtained the prescription drug product 

9 without providing the information required 

10 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 without 

19 providing the information required under 

20 such subparagraph. 

21 ‘‘(D) REQUESTS FOR INFORMATION.—Upon 

22 a request by the Secretary or other appropriate 

23 Federal or State official, in the event of a recall 

24 or for the purpose of investigating a suspect pre25 scription drug product or an illegitimate premstockstill on DSK4VPTVN1PROD with BILLS

45 

•HR 1919 RH

1 scription drug product, a dispenser shall, not 

2 later than 2 business days after receiving the re3 quest or in another such reasonable time as de4 termined by the Secretary, provide lot level 

5 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 engage 

10 in transactions involving a prescription drug product 

11 only if such prescription drug product is encoded 

12 with a prescription drug product identifier, except as 

13 provided in subsection (a)(4). 

14 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Begin15 ning 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 de25 termination that a prescription drug prodmstockstill on DSK4VPTVN1PROD with BILLS

46 

•HR 1919 RH

1 uct in the possession or control of the dis2 penser is a suspect prescription drug prod3 uct, or upon receiving a request for 

4 verification from the Secretary that a pre5 scription drug product within the possession 

6 or control of a dispenser is a suspect pre7 scription drug product, a dispenser shall 

8 promptly conduct an investigation to deter9 mine whether the prescription drug product 

10 is an illegitimate prescription drug product. 

11 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 product; 

16 ‘‘(II) beginning 8 years after the 

17 date of the enactment of the Safe18 guarding America’s Pharmaceuticals 

19 Act of 2013, verifying that the product 

20 identifier of at least 3 packages or 10 

21 percent of such suspect prescription 

22 drug product, whichever is greater, or 

23 all packages, if there are fewer than 3, 

24 corresponds with the prescription drug 

25 product identifier for such product; 

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•HR 1919 RH

1 ‘‘(III) validating any applicable 

2 transaction history in the possession of 

3 the dispenser; and 

4 ‘‘(IV) otherwise investigating to 

5 determine whether the prescription 

6 drug product is an illegitimate pre7 scription drug product. 

8 ‘‘(ii) CLEARED PRESCRIPTION DRUG

9 PRODUCT.—If the dispenser makes the de10 termination that a suspect prescription 

11 drug product is not an illegitimate pre12 scription drug product, the dispenser shall 

13 promptly notify the Secretary of such deter14 mination and such prescription drug prod15 uct may be further dispensed. 

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

17 keep records of its investigation of a suspect 

18 prescription drug product for not less than 

19 3 years after the conclusion of the investiga20 tion. 

21 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

22 PRODUCT.— 

23 ‘‘(i) IN GENERAL.—Upon receiving no24 tice that a manufacturer of a prescription 

25 drug product has determined that a premstockstill on DSK4VPTVN1PROD with BILLS

48 

•HR 1919 RH

1 scription drug product in the possession or 

2 control of a dispenser is an illegitimate pre3 scription drug product, the dispenser 

4 shall— 

5 ‘‘(I) quarantine such prescription 

6 drug product within the possession or 

7 control of the dispenser from prescrip8 tion drug product intended for dis9 tribution; and 

10 ‘‘(II) provide for the disposition of 

11 the illegitimate prescription drug prod12 uct within the possession or control of 

13 the dispenser. 

14 ‘‘(ii) TRADING PARTNERS.—Upon de15 termining that a prescription drug product 

16 in the possession or control of a trading 

17 partner is an illegitimate prescription drug 

18 product, the dispenser shall take reasonable 

19 steps to assist a trading partner to provide 

20 for the disposition of the illegitimate pre21 scription drug product. 

22 ‘‘(iii) MAKING A NOTIFICATION.—Upon 

23 determining that a prescription drug prod24 uct in the possession or control of the dis25 penser is an illegitimate prescription drug 

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•HR 1919 RH

1 product, the dispenser shall notify the Sec2 retary of such determination not later than 

3 24 hours after making such determination. 

4 The Secretary shall determine whether addi5 tional trading partner notification is ap6 propriate. 

7 ‘‘(iv) RESPONDING TO A NOTIFICA8 TION.—Upon the receipt of a notification 

9 from the Secretary that a determination has 

10 been made that a prescription drug product 

11 is an illegitimate prescription drug product, 

12 a dispenser shall— 

13 ‘‘(I) identify all illegitimate pre14 scription drug products that are sub15 ject to such notification and in the pos16 session or control of the dispenser, in17 cluding any prescription drug product 

18 that is subsequently received; and 

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

21 ‘‘(v) RECORDS.—A dispenser shall keep 

22 records of the disposition of an illegitimate 

23 prescription drug product for not less than 

24 3 years after the conclusion of the disposi25 tion. 

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•HR 1919 RH

1 ‘‘(C) ELECTRONIC DATABASE.—A dispenser 

2 may satisfy the requirements of this paragraph 

3 through the use of a secure electronic database 

4 developed and operated by the manufacturer or 

5 another entity. The owner of such database shall 

6 establish the requirements and processes to enable 

7 responding to requests and may provide for data 

8 access to other members of the pharmaceutical 

9 distribution supply chain, as appropriate. The 

10 development and operation of such a database 

11 shall not relieve a dispenser of the requirement 

12 under this paragraph to respond to a 

13 verification request submitted by means other 

14 than a secure electronic database. 

15 ‘‘(e) REPACKAGER REQUIREMENTS.— 

16 ‘‘(1) PRESCRIPTION DRUG PRODUCT TRACING.— 

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

18 than April 1, 2015, with respect to a prescrip19 tion drug product received by a repackager from 

20 a wholesale distributor, and beginning not later 

21 than January 1, 2015, with respect to any other 

22 prescription drug product, a repackager 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 transmstockstill on DSK4VPTVN1PROD with BILLS

51 

•HR 1919 RH

1 action, provides transaction history and a 

2 transaction statement for the prescription 

3 drug product; 

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

5 transaction in which the repackager trans6 fers ownership of a prescription drug prod7 uct, provide the subsequent owner with 

8 transaction history and a transaction state9 ment; 

10 ‘‘(iii) maintain the transaction infor11 mation for each transaction described in 

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

13 after the transaction; and 

14 ‘‘(iv) maintain records that allow the 

15 repackager to associate the prescription 

16 drug product identifier the repackager af17 fixes or imprints with the prescription drug 

18 product identifier assigned by the original 

19 manufacturer of the prescription drug prod20 uct. 

21 ‘‘(B) NONSALEABLE RETURNS.—Notwith22 standing subparagraph (A)(ii), a repackager 

23 may return prescription drug product to the 

24 trading partner from whom the repackager ob25 tained the prescription drug product without 

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•HR 1919 RH

1 providing the information required under such 

2 subparagraph. 

3 ‘‘(C) REQUESTS FOR INFORMATION.—Upon 

4 a request by the Secretary or other appropriate 

5 Federal or State official, in the event of a recall 

6 or for the purpose of investigating a suspect pre7 scription drug product or an illegitimate pre8 scription drug product, a repackager shall, not 

9 later than 2 business days after receiving the re10 quest or in such other reasonable time as deter11 mined by the Secretary, provide the applicable 

12 transaction history and transaction statement 

13 for the prescription drug product. 

14 ‘‘(2) PRESCRIPTION DRUG PRODUCT IDENTI15 FIER.—Beginning not later than 6 years after the 

16 date of the enactment of the Safeguarding America’s 

17 Pharmaceuticals Act of 2013, a repackager— 

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

19 drug product identifier to each package and ho20 mogenous case of prescription drug product in21 tended to be introduced in a transaction; 

22 ‘‘(B) shall maintain the prescription drug 

23 product identifier for such prescription drug 

24 product for not less than 3 years after the date 

25 of the transaction; and 

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•HR 1919 RH

1 ‘‘(C) may engage in transactions involving 

2 a prescription drug product only if such pre3 scription drug product is encoded with a pre4 scription drug product identifier except as pro5 vided in subsection (a)(4). 

6 ‘‘(3) AUTHORIZED TRADING PARTNERS.—Begin7 ning on January 1, 2015, a repackager shall ensure 

8 that each of its trading partners is authorized. 

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

10 January 1, 2015, a repackager shall implement sys11 tems to enable the repackager to comply with the fol12 lowing requirements: 

13 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD14 UCT.— 

15 ‘‘(i) IN GENERAL.—Upon making a de16 termination that a prescription drug prod17 uct in the possession or control of the re18 packager is a suspect prescription drug 

19 product, or upon receiving a request for 

20 verification from the Secretary that a pre21 scription drug product within the possession 

22 or control of a repackager is a suspect pre23 scription drug product, a repackager shall 

24 promptly conduct an investigation to deter25 mine whether the prescription drug product 

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•HR 1919 RH

1 is an illegitimate prescription drug product, 

2 including— 

3 ‘‘(I) beginning not later than 6 

4 years after the date of the enactment of 

5 the Safeguarding America’s Pharma6 ceuticals Act of 2013, verifying the pre7 scription drug product at the package 

8 level; 

9 ‘‘(II) validating any applicable 

10 transaction information in the posses11 sion of the repackager; 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 repackager determines 

18 that a suspect prescription drug product is 

19 not an illegitimate prescription drug prod20 uct, the repackager shall promptly notify 

21 the Secretary of such determination and 

22 such prescription drug product may be fur23 ther distributed. 

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

25 keep records of its investigation of a suspect 

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•HR 1919 RH

1 prescription drug product for not less than 

2 3 years after the conclusion of the investiga3 tion. 

4 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

5 PRODUCT.— 

6 ‘‘(i) IN GENERAL.—Upon receiving no7 tice that a manufacturer of a prescription 

8 drug product has determined that a pre9 scription drug product in the possession or 

10 control of a repackager is an illegitimate 

11 prescription drug product, the repackager 

12 shall— 

13 ‘‘(I) quarantine such prescription 

14 drug product within the possession or 

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

17 distribution; and 

18 ‘‘(II) provide for the disposition of 

19 the illegitimate prescription drug prod20 uct within the possession or control of 

21 the repackager. 

22 ‘‘(ii) TRADING PARTNER.—Upon deter23 mining that a prescription drug product in 

24 the possession or control of a trading part25 ner is an illegitimate prescription drug 

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1 product, the repackagers shall take reason2 able steps to assist the trading partner to 

3 provide for the disposition of the illegit4 imate prescription drug product. 

5 ‘‘(iii) MAKING A NOTIFICATION.—Upon 

6 determining that a prescription drug prod7 uct in the possession or control of the re8 packager is an illegitimate prescription 

9 drug product, the repackager shall notify 

10 the Secretary of such determination not 

11 later than 24 hours after making such deter12 mination. The Secretary shall determine 

13 whether additional trading partner notifi14 cation is appropriate. 

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

17 from the Secretary that a determination has 

18 been made that a prescription drug product 

19 is an illegitimate prescription drug product, 

20 a repackager shall— 

21 ‘‘(I) identify all illegitimate pre22 scription drug products that are sub23 ject to such notification and in the pos24 session or control of the repackager, inmstockstill on DSK4VPTVN1PROD with BILLS

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1 cluding any prescription drug product 

2 that is subsequently received; and 

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

5 ‘‘(v) RECORDS.—A repackager shall 

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

8 than 3 years after the conclusion of the dis9 position. 

10 ‘‘(C) ELECTRONIC DATABASE.—A repack11 ager may satisfy the requirements of this para12 graph through the use of a secure electronic data13 base developed and operated by the manufacturer 

14 or another entity. The owner of such database 

15 shall establish the requirements and processes to 

16 respond to requests and may provide for data ac17 cess to other members of the pharmaceutical dis18 tribution supply chain, as appropriate. The de19 velopment and operation of such a database shall 

20 not relieve a repackager of the requirement under 

21 this paragraph to respond to a verification re22 quest submitted by means other than a secure 

23 electronic database. 

24 ‘‘(D) RETURNED PRESCRIPTION DRUG

25 PRODUCT.—Beginning not later than 6 years 

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1 after the date of the enactment of the Safe2 guarding America’s Pharmaceuticals Act of 

3 2013, upon receipt of a returned prescription 

4 drug product that the repackager intends to fur5 ther distribute, before further distributing such 

6 prescription drug product, the repackager 

7 shall— 

8 ‘‘(i) verify the prescription drug prod9 uct identifier for each sealed homogeneous 

10 case of such prescription drug product; or 

11 ‘‘(ii) if such prescription drug product 

12 is not in a sealed homogeneous case, verify 

13 the prescription drug product identifier on 

14 each package. 

15 ‘‘(f) THIRD-PARTY LOGISTICS PROVIDER REQUIRE16 MENTS.— 

17 ‘‘(1) AUTHORIZED TRADING PARTNERS.—Begin18 ning on January 1, 2015, a third-party logistics pro19 vider shall ensure that each of its trading partners is 

20 authorized. 

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

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

23 shall implement systems to enable the third-party lo24 gistics provider to comply with the following require25 ments: 

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1 ‘‘(A) SUSPECT PRESCRIPTION DRUG PROD2 UCT.— 

3 ‘‘(i) IN GENERAL.—Upon making a de4 termination that a prescription drug prod5 uct in the possession or control of a third6 party logistics provider is a suspect pre7 scription drug product, a third-party logis8 tics provider shall promptly notify the 

9 owner of such prescription drug product of 

10 the need to conduct an investigation to de11 termine whether the prescription drug prod12 uct is an illegitimate prescription drug 

13 product. 

14 ‘‘(ii) CLEARED PRESCRIPTION DRUG

15 PRODUCT.—If the owner of the prescription 

16 drug product notifies the third-party logis17 tics provider of the determination that a 

18 suspect prescription drug product is not an 

19 illegitimate prescription drug product, such 

20 prescription drug product may be further 

21 distributed. 

22 ‘‘(iii) RECORDS.—A third-party logis23 tics provider shall keep records of the activi24 ties described in clauses (i) and (ii) with re25 spect to a suspect prescription drug product 

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1 for not less than 3 years after the conclusion 

2 of the investigation. 

3 ‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG

4 PRODUCT.— 

5 ‘‘(i) IN GENERAL.—Upon receiving no6 tice that a manufacturer of a prescription 

7 drug product has determined that a pre8 scription drug product in the possession or 

9 control of a third-party logistics provider is 

10 an illegitimate prescription drug product, 

11 the third-party logistics provider shall— 

12 ‘‘(I) quarantine such prescription 

13 drug product within the possession or 

14 control of the third-party logistics pro15 vider from prescription drug product 

16 intended for distribution; 

17 ‘‘(II) promptly notify the owner of 

18 such prescription drug product of the 

19 need to provide for the disposition of 

20 such prescription drug product; and 

21 ‘‘(III) promptly transfer posses22 sion of the prescription drug product 

23 to the owner of such prescription drug 

24 product to provide for the disposition 

25 of the prescription drug product. 

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1 ‘‘(ii) MAKING A NOTIFICATION.—Upon 

2 determining that a prescription drug prod3 uct in the possession or control of the third4 party logistics provider is an illegitimate 

5 prescription drug product, the third-party 

6 logistics provider shall notify the Secretary 

7 not later than 24 hours after making such 

8 determination. The Secretary shall deter9 mine whether additional trading partner 

10 notification is appropriate. 

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

13 from the Secretary, a third-party logistics 

14 provider shall— 

15 ‘‘(I) identify all illegitimate pre16 scription drug product subject to such 

17 notification that is in the possession or 

18 control of the third-party logistics pro19 vider, including any prescription drug 

20 product that is subsequently received; 

21 and 

22 ‘‘(II) perform the activities de23 scribed in clause (i). 

24 ‘‘(iv) RECORDS.—A third-party logis25 tics provider shall keep records of the activimstockstill on DSK4VPTVN1PROD with BILLS

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1 ties described in clauses (i) and (ii) with re2 spect to an illegitimate prescription drug 

3 product for not less than 3 years after the 

4 conclusion of the disposition. 

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

6 to any entity, notwithstanding its status as a wholesale dis7 tributor or repackager, or other status that is not involved 

8 in the physical handling, distribution, or storage of a pre9 scription drug product. For purposes of this subsection, fa10 cilitating the distribution of a prescription drug product 

11 by providing various administrative services, including 

12 processing of orders and payments, shall not, by itself, be 

13 construed as being involved in the handling, distribution, 

14 or storage of a prescription drug product.’’. 

15 SEC. 3. ENHANCED DRUG DISTRIBUTION SECURITY. 

16 (a) PILOT PROJECTS.— 

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

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

19 shall establish one or more pilot projects in coordina20 tion with manufacturers, repackagers, wholesale dis21 tributors, third-party logistics providers, and dis22 pensers to explore and evaluate methods to enhance 

23 the safety and security of the pharmaceutical dis24 tribution supply chain. 

25 (2) CONTENT.— 

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

3 collectively— 

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

6 (ii) include participants representative 

7 of every sector within the pharmaceutical 

8 distribution supply chain, including par9 ticipants representative of small businesses. 

10 (B) PROJECT DESIGN.—The pilot projects 

11 shall be designed to— 

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

14 drug product, which utilization may in15 clude— 

16 (I) verification of the prescription 

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

19 (II) the use of aggregation and in20 ference; 

21 (ii) improve the technical capabilities 

22 of each sector within the pharmaceutical 

23 supply chain to comply with systems and 

24 processes needed to utilize the prescription 

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1 drug product identifiers to enhance tracing 

2 of a prescription drug product; and 

3 (iii) conduct such other activities as 

4 the Secretary determines appropriate to ex5 plore and evaluate methods to enhance the 

6 safety and security of the pharmaceutical 

7 distribution supply chain. 

8 (b) PUBLIC MEETINGS.— 

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

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

11 every 6 months thereafter until the submission of the 

12 report required by subsection (e)(2), the Secretary 

13 shall hold a public meeting to enhance the safety and 

14 security of the pharmaceutical distribution supply 

15 chain. In conducting such meetings, the Secretary 

16 shall take all measures reasonable and practicable to 

17 ensure the protection of confidential commercial in18 formation and trade secrets. 

19 (2) CONTENT.—In conducting meetings under 

20 this subsection, the Secretary shall seek to address, in 

21 at least one such meeting, each of the following topics: 

22 (A) Best practices in each of the sectors 

23 within the pharmaceutical distribution supply 

24 chain to implement the requirements of section 

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1 582 of the Federal Food, Drug, and Cosmetic 

2 Act, as added by section 2. 

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

5 each pharmaceutical distribution supply chain 

6 sector and on public health. 

7 (C) Whether additional electronic 

8 traceability requirements, including tracing of 

9 prescription drug product at the package level, 

10 are feasible, cost effective, overly burdensome on 

11 small businesses, and needed to protect public 

12 health. 

13 (D) The systems and processes needed to 

14 utilize the prescription drug product identifiers 

15 to enhance tracing of prescription drug product 

16 at the package level. 

17 (E) The technical capabilities and legal au18 thorities, if any, needed to establish an electronic 

19 system that provides for enhanced tracing of pre20 scription drug product at the package level. 

21 (F) The impact that the requirements, sys22 tems, processes, capabilities, and legal authori23 ties referred to in subparagraphs (C), (D), and 

24 (E) would have on patient safety, the drug sup25 ply, cost and regulatory burden, the timeliness of 

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1 patient access to prescription drugs, and small 

2 businesses. 

3 (c) STUDY OF THE PHARMACEUTICAL DISTRIBUTION

4 SUPPLY CHAIN.— 

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

6 the United States shall conduct a study to examine 

7 implementation of the requirements established under 

8 subchapter H of chapter V of the Federal Food, Drug, 

9 and Cosmetic Act, as added by section 2, in order to 

10 inform the regulations promulgated under this sec11 tion. 

12 (2) CONSIDERATION.—In conducting the study 

13 under this subsection, the Comptroller General shall 

14 provide for stakeholder input and shall consider the 

15 following: 

16 (A) The implementation of the requirements 

17 established under such subchapter H with respect 

18 to— 

19 (i) the ability of the health care system 

20 collectively to maintain patient access to 

21 medicines; 

22 (ii) the scalability of such require23 ments, including with respect to prescrip24 tion drug product lines; and 

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1 (iii) the capability of different sectors 

2 within the pharmaceutical distribution sup3 ply chain, including small businesses, to 

4 affix and utilize the prescription drug prod5 uct identifier. 

6 (B) The need for additional legal authori7 ties and activities to address additional gaps in 

8 the pharmaceutical distribution supply chain, if 

9 any, after the implementation of the require10 ments established under such subchapter H with 

11 respect to— 

12 (i) the systems and processes needed to 

13 enhance tracing of prescription drug prod14 uct at the package level; 

15 (ii) the impact, feasibility, and cost ef16 fectiveness that additional requirements 

17 pursuant to this section would have on each 

18 pharmaceutical distribution supply chain 

19 sector and the public health; and 

20 (iii) the systems and processes needed 

21 to enhance interoperability among trading 

22 partners. 

23 (C) Risks to the security and privacy of 

24 data collected, maintained, or exchanged pursumstockstill on DSK4VPTVN1PROD with BILLS

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1 ant to the requirements established under such 

2 subchapter H. 

3 (d) SMALL DISPENSERS.— 

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

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

6 shall enter into a contract with a private, inde7 pendent consulting firm with relevant expertise to 

8 conduct a technology and software study on the feasi9 bility of dispensers that have 25 or fewer full-time 

10 employees conducting interoperable, electronic tracing 

11 of prescription drug products at the package level. 

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

13 a contract under paragraph (1), the private inde14 pendent consulting firm awarded such contract shall 

15 agree to consult with dispensers that have 25 or fewer 

16 full-time employees when conducting the study under 

17 such subparagraph. 

18 (3) STUDY CONTENT.—The study conducted 

19 under paragraph (1) shall assess whether, with re20 spect to conducting interoperable, electronic tracing of 

21 prescription drug products at the package level, the 

22 necessary hardware and software— 

23 (A) is readily accessible to such dispensers; 

24 (B) is not prohibitively expensive to obtain, 

25 install, and maintain for such dispensers; and 

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1 (C) can be integrated into business prac2 tices, such as interoperability with wholesale dis3 tributors, for such dispensers. 

4 (4) PUBLICATION.—The Secretary shall pub5 lish— 

6 (A) the statement of work for the study con7 ducted under paragraph (1) for public comment 

8 not later than 30 days before commencing the 

9 study; and 

10 (B) the final version of such study for pub11 lic comment not later than 30 days after such 

12 study is completed. 

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

14 days after the date on which the study conducted 

15 under paragraph (1) is completed, the Secretary shall 

16 submit to the Committee on Energy and Commerce of 

17 the House of Representatives and the Committee on 

18 Health, Education, Labor, and Pensions of the Sen19 ate, a report on the findings of the study and any rec20 ommendations to improve the technology and software 

21 available to small dispensers for purposes of con22 ducting electronic, interoperable tracing of prescrip23 tion drug products at the package level. 

24 (6) PUBLIC MEETING.—Not later than 180 days 

25 after the date on which the study conducted under 

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1 paragraph (1) is completed, the Secretary shall hold 

2 a public meeting at which members of the public, in3 cluding stakeholders, may present their views on the 

4 study. 

5 (e) REPORTS.— 

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

7 the date of the enactment of this Act, the Comptroller 

8 General shall submit to the Committee on Energy and 

9 Commerce of the House of Representatives and the 

10 Committee on Health, Education, Labor, and Pen11 sions of the Senate a report on the results of the study 

12 conducted under subsection (c). 

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

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

15 shall submit to the Committee on Energy and Com16 merce of the House of Representatives and the Com17 mittee on Health, Education, Labor, and Pensions of 

18 the Senate a report on the results of the pilot program 

19 conducted under subsection (a), taking into consider20 ation— 

21 (A) the comments received during the public 

22 meetings conducted under subsection (b); and 

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

24 the public comments received during the public 

25 meeting held, under subsection (d). 

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1 (f) ESTABLISHMENT OF ADDITIONAL REQUIRE2 MENTS.— 

3 (1) IN GENERAL.—Notwithstanding any other 

4 provision of this Act, including the amendments made 

5 by this Act, not earlier than January 1, 2027, and 

6 not later than March 1, 2027, the Secretary shall 

7 issue proposed regulations that establish additional 

8 requirements to prevent a suspect product, illegit9 imate product, or a product that is counterfeit, stolen, 

10 diverted, or otherwise unfit for distribution from en11 tering into or being further distributed in the supply 

12 chain, including— 

13 (A) requirements related to the use of inter14 operable electronic systems and technologies for 

15 enhanced tracing of prescription drug product at 

16 the package level, which may include verification 

17 of the prescription drug product identifier of a 

18 package of prescription drug product and en19 hanced verification of saleable returns; 

20 (B) requirements related to the use of addi21 tional prescription drug product identifiers or 

22 prescription drug product identifier technology 

23 that meet the standards developed under section 

24 582(a)(2) of the Federal Food, Drug, and Cos25 metic Act, as added by section 2; 

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1 (C) requirements related to the use of aggre2 gation, inference, and other methods, if deter3 mined to be necessary components of the systems 

4 and technologies referred to in subparagraph (A); 

5 and 

6 (D) other data transmission and mainte7 nance requirements and interoperability stand8 ards. 

9 (2) FLEXIBILITY.—The requirements described in 

10 paragraph (1) shall provide for flexibility for a mem11 ber of the pharmaceutical supply chain, by— 

12 (A) with respect to dispensers, allowing a 

13 dispenser to enter into a written agreement with 

14 a third party, including an authorized wholesale 

15 distributor, under which— 

16 (i) the third party confidentially 

17 maintains any information required to be 

18 maintained under such requirements for the 

19 dispenser; and 

20 (ii) the dispenser maintains a copy of 

21 the written agreement and is not relieved of 

22 the other obligations of the dispenser under 

23 such requirements; 

24 (B) establishing a process by which an au25 thorized manufacturer, repackager, wholesale dismstockstill on DSK4VPTVN1PROD with BILLS

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1 tributor, or dispenser may request a waiver from 

2 any such requirements if the Secretary deter3 mines that such requirements would result in an 

4 undue economic hardship on the manufacturer, 

5 wholesale distributor, or dispenser; 

6 (C) not requiring the adoption of specific 

7 business systems by a member of the pharma8 ceutical supply chain for the maintenance and 

9 transmission of prescription drug product trac10 ing data; and 

11 (D) prescribing alternative methods of com12 pliance for small businesses, as specified in 

13 paragraph (4). 

14 (3) CONSIDERATIONS.—In issuing proposed reg15 ulations under paragraph (1), the Secretary shall 

16 consider— 

17 (A) the results of the pilot project conducted 

18 under subsection (a); 

19 (B) the public meetings held under sub20 section (b); 

21 (C) the studies conducted under subsections 

22 (c) and (d); 

23 (D) the reports submitted under subsection 

24 (e); 

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1 (E) the public health benefits of such regula2 tions compared with the cost of compliance with 

3 the requirements contained in such regulations, 

4 including with respect to entities of varying sizes 

5 and capabilities; and 

6 (F) the diversity of the pharmaceutical dis7 tribution supply chain by providing appropriate 

8 flexibility for each sector in the supply chain, in9 cluding small businesses. 

10 (4) SMALL BUSINESS PROTECTION.—The Sec11 retary, taking into consideration the study conducted 

12 under paragraph (d), shall, if the Secretary deter13 mines that the requirements established pursuant to 

14 paragraph (1) would result in an undue economic 

15 hardship on small businesses, provide for alternative 

16 methods of compliance with any such requirement by 

17 small businesses, including— 

18 (A) establishing timelines for such compli19 ance (including compliance by dispensers with 

20 25 or fewer full-time employees) that do not im21 pose undue economic hardship for small busi22 nesses, including dispensers with respect to 

23 which the study concluded has insufficient hard24 ware and software to conduct interoperable, elecmstockstill on DSK4VPTVN1PROD with BILLS

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1 tronic tracing of prescription drug products at 

2 the package level; and 

3 (B) establishing a process by which a dis4 penser may request a waiver from any such re5 quirement. 

6 (5) REGULATIONS.—In issuing regulations to 

7 carry out this subsection, the Secretary shall— 

8 (A) issue a notice of proposed rulemaking 

9 that includes a copy of the proposed rule; 

10 (B) provide for a period of not less than 60 

11 days for comments on the proposed rule; and 

12 (C) provide for an effective date of the final 

13 rule that is 2 years after the date on which such 

14 final rule is published. 

15 (6) SUNSET.—The requirements regarding the 

16 provision and receipt of transaction history and 

17 transaction statements under section 582 of the Fed18 eral Food, Drug, and Cosmetic Act, as added by sec19 tion 2, shall cease to be effective on the date on which 

20 the regulations issued under this section are fully im21 plemented. 

22 (g) DEFINITIONS.—In this section: 

23 (1) The terms defined in section 581 of the Fed24 eral Food, Drug, and Cosmetic Act, as added by secmstockstill on DSK4VPTVN1PROD with BILLS

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1 tion 2, shall have the same meanings in this section 

2 as such terms are given in such section 581. 

3 (2) The term ‘‘Secretary’’ means the Secretary of 

4 Health and Human Services, acting through the Com5 missioner of Food and Drugs. 

6 SEC. 4. NATIONAL STANDARDS FOR WHOLESALE DISTRIBU7 TORS. 

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

9 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend10 ed— 

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

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

13 purposes of this subsection and subsection (d)—’’ and 

14 inserting the following: 

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

16 (2) in section 503(e) (21 U.S.C. 353(e)), by re17 designating subparagraphs (A) and (B) as para18 graphs (1) and (2), respectively; and 

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

20 adding at the end the following: 

21 ‘‘SEC. 583. NATIONAL STANDARDS FOR WHOLESALE DIS22 TRIBUTORS. 

23 ‘‘(a) STANDARDS.— 

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1 ‘‘(1) IN GENERAL.—The Secretary shall establish, 

2 by regulation, standards for the licensing of persons 

3 that make wholesale distributions. 

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

5 paragraph (1) shall, with respect to wholesale dis6 tributions, include requirements for— 

7 ‘‘(A) the storage and handling of drugs sub8 ject to section 503(b)(1), including facility re9 quirements; 

10 ‘‘(B) the establishment and maintenance of 

11 records of the distributions of such drugs; 

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

13 equivalent means of security in accordance with 

14 paragraph (3); 

15 ‘‘(D) mandatory background checks and 

16 fingerprinting of facility managers or designated 

17 representatives; 

18 ‘‘(E) the establishment and implementation 

19 of qualifications for key personnel; 

20 ‘‘(F) the mandatory physical inspection of 

21 any facility to be used in wholesale distribution 

22 within a reasonable timeframe from the initial 

23 application for licensure of the wholesale dis24 tributor; and 

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

2 prohibition of certain persons from engaging in 

3 wholesale distribution. 

4 ‘‘(3) BOND OR OTHER SECURITY.—The require5 ments under paragraph (2)(C) shall provide for the 

6 following: 

7 ‘‘(A) An applicant that is not a govern8 ment-owned-and-operated wholesale distributor, 

9 for the issuance or renewal of a wholesale dis10 tributor license, shall submit a surety bond of 

11 $100,000 or other equivalent means of security 

12 acceptable to the applicable licensing authority. 

13 ‘‘(B) For purposes of subparagraph (A), the 

14 applicable licensing authority may accept a sur15 ety bond less than $100,000 if the annual gross 

16 receipts of the previous tax year for the wholesale 

17 distributor is $10,000,000 or less, in which case 

18 the surety bond may not be less than $25,000. 

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

20 evidence that it possesses the required bond in a 

21 State, the requirement for a bond in another 

22 State is waived. 

23 ‘‘(4) INSPECTIONS.—To satisfy the inspection re24 quirement under paragraph (2)(F), the Secretary 

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1 may conduct the inspection, or may accept an inspec2 tion by— 

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

4 the facility is located; or 

5 ‘‘(B) a third-party accreditation or inspec6 tion service approved by the Secretary. 

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

8 under paragraph (2) shall include requirements to 

9 prohibit a person from receiving or maintaining li10 censure for wholesale distribution if the person— 

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

12 conduct relating to wholesale distribution; any 

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

14 any felony violation of section 1365 of title 18, 

15 United States Code, relating to prescription drug 

16 product tampering; or 

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

18 the requirements of this section that presents a 

19 threat of serious adverse health consequences or 

20 death to humans. 

21 ‘‘(b) REPORTING BY LICENSED WHOLESALE DIS22 TRIBUTORS.— 

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

24 than 1 year after the date of the enactment of this sec25 tion, each person engaged in wholesale distribution in 

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1 interstate commerce shall submit on an annual basis, 

2 and update as necessary, a report to the Secretary in3 cluding— 

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

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

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

7 wholesale distributor is licensed for wholesale 

8 distribution; and 

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

10 State, the Federal Government, or a foreign gov11 ernment during the reporting period against the 

12 wholesale distributor. 

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

14 shall post on the public Internet Website of the Food 

15 and Drug Administration the name of each wholesale 

16 distributor, and the State in which each such dis17 tributor is licensed, based on reports under paragraph 

18 (1). 

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

20 subchapter does not prohibit a State from— 

21 ‘‘(1) licensing wholesale distributors for the con22 duct of wholesale distribution activities in the State 

23 in accordance with this subchapter; and 

24 ‘‘(2) collecting fees from wholesale distributors in 

25 connection with such licensing, 

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

2 extent to which an entity is engaged in third-party logistics 

3 provider activities. 

4 ‘‘(d) DEFINITION.—In this section, the term ‘wholesale 

5 distribution’ means the distribution of a drug subject to sec6 tion 503(b)(1) to a person other than a consumer or patient, 

7 but does not include— 

8 ‘‘(1) intracompany distribution of any drug be9 tween members of an affiliated group (as defined in 

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

11 1986); 

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

13 distribute a drug among hospitals or other health care 

14 entities which are under common control; 

15 ‘‘(3) the distribution of a drug or an offer to dis16 tribute a drug for emergency medical reasons, includ17 ing a public health emergency declaration pursuant 

18 to section 319 of the Public Health Service Act, except 

19 that a drug shortage not caused by a public health 

20 emergency shall not constitute such an emergency 

21 medical reason; 

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

23 prescription executed in accordance with subsection 

24 503(b)(1); 

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

2 drug by a licensed retail pharmacy to a licensed 

3 practitioner for office use; 

4 ‘‘(6) the distribution of a drug or an offer to dis5 tribute a drug by a charitable organization to a non6 profit affiliate of the organization to the extent other7 wise permitted by law; 

8 ‘‘(7) the purchase or other acquisition by a dis9 penser, hospital, or other health care entity of a drug 

10 for use by such dispenser, hospital, or other health 

11 care entity; 

12 ‘‘(8) the distribution of a drug by the manufac13 turer of such drug; 

14 ‘‘(9) the receipt or transfer of a drug by an au15 thorized third-party logistics provider provided that 

16 such third-party logistics provider does not take own17 ership of the drug; 

18 ‘‘(10) the transport of a drug by a common car19 rier, provided that the common carrier does not take 

20 ownership of the drug; 

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

22 distribute a drug, by an authorized repackager that 

23 has taken ownership of the drug and repacked it in 

24 accordance with section 582(e); 

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1 ‘‘(12) saleable drug returns when conducted by a 

2 dispenser in accordance with section 203.23 of title 

3 21, Code of Federal Regulations (or any successor reg4 ulation); 

5 ‘‘(13) the distribution of a combination prescrip6 tion drug product described in section 

7 581(20)(B)(xiii); 

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

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

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

11 that, by its formulation, is intended for the replenish12 ment of fluids and electrolytes (such as sodium, chlo13 ride, and potassium) or calories (such as dextrose and 

14 amino acids); 

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

16 used to maintain the equilibrium of water and min17 erals in the body, such as dialysis solutions; 

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

19 for irrigation or reconstitution, or sterile water, 

20 whether intended for such purposes or for injection; 

21 ‘‘(18) the distribution of compressed medical gas 

22 (as defined in section 581(21)(C)); 

23 ‘‘(19) facilitating the distribution of a prescrip24 tion drug product by providing administrative serv25 ices, such as processing of orders and payments, withmstockstill on DSK4VPTVN1PROD with BILLS

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1 out physical handling, distribution, or storage of a 

2 prescription drug product; or 

3 ‘‘(20)(A) the distribution of a product by a dis4 penser, or a wholesale distributor acting at the direc5 tion of the dispenser, to a repackager registered under 

6 section 510 for the purpose of repackaging the drug 

7 for use by that dispenser or another health care entity 

8 that is under the dispenser’s ownership or control, so 

9 long as the dispenser retains ownership of the pre10 scription drug product; and 

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

12 repackager of such prescription drug product. 

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

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

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

16 issue the regulations required by subsection (a) not later 

17 than 1 year after the date of the enactment of this Act.’’. 

18 (b) CONFORMING AMENDMENT.—Section 804(a)(5)(A) 

19 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

20 384(a)(5)(A)) is amended by striking ‘‘503(e)(2)(A)’’ and 

21 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, Drug, 

4 and Cosmetic Act, as amended by section 4, is further 

5 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 does 

18 not have such a program; and 

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

20 facility is not licensed by the Secretary under para21 graph (1)(B), registers with the State into which the 

22 drug is distributed if such State requires such reg23 istration. 

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 sec3 tion, each facility engaged in the activities of a third4 party logistics provider shall submit on an annual 

5 basis, and update as necessary, a report to the Sec6 retary 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 licensed 

11 for third-party logistics provider activities; and 

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

13 State or Federal licensing authority during the 

14 reporting period against the facility. 

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

16 shall post on the public Internet Website of the Food 

17 and Drug Administration the name of each third18 party logistics provider, and each jurisdiction (wheth19 er State or Federal) in which the provider is licensed, 

20 based on reports under paragraph (1). 

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

22 subchapter does not prohibit a State from— 

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

24 the conduct of third-party logistics provider activities 

25 in the State in accordance with this subchapter; and 

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1 ‘‘(2) collecting fees from third-party logistics pro2 viders in connection with such licensing, 

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

4 extent to which an entity is engaged in wholesale distribu5 tion. 

6 ‘‘(d) COSTS.— 

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

8 case of a facility engaging in the activities of a third9 party logistics provider licensed by the Secretary 

10 under this section, the Secretary may assess and col11 lect a reasonable fee in an amount equal to the costs 

12 to the Federal Government of establishing and admin13 istering the licensure program established, and con14 ducting period inspections, under this section. 

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

16 the amount of the fee under paragraph (1) on an an17 nual basis, if necessary, to generate an amount of rev18 enue equal to the costs referred to in such paragraph. 

19 ‘‘(3) AVAILABILITY.—Fees assessed and collected 

20 under this subsection shall be available for obligation 

21 only to the extent and in the amount provided in ad22 vance in appropriations Acts. Such fees shall remain 

23 available until expended. 

24 ‘‘(e) LICENSE REGULATIONS.— 

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1 ‘‘(1) IN GENERAL.—The Secretary shall establish, 

2 by regulation, standards, terms, and conditions for li3 censing persons to engage in third-party logistics pro4 vider activities. 

5 ‘‘(2) CONTENT.—The regulations under para6 graph (1) shall— 

7 ‘‘(A) include standards relating to eligi8 bility for, and revocation and reissuance of, li9 censes; 

10 ‘‘(B) establish a process by which the appli11 cable licensing authority will, upon request by a 

12 third-party logistics provider that is accredited 

13 by a third-party accreditation program ap14 proved by the Secretary, issue a license to the 

15 provider; 

16 ‘‘(C) establish a process by which the Sec17 retary shall issue a license to a third-party logis18 tics provider if the Secretary is not able to ap19 prove a third-party accreditation program be20 cause no such program meets the Secretary’s re21 quirements necessary for approval of such a 

22 third-party accreditation program; 

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

24 provider comply with storage practices, as determstockstill on DSK4VPTVN1PROD with BILLS

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1 mined by the Secretary, at the provider’s facili2 ties, including— 

3 ‘‘(i) maintaining access to warehouse 

4 space of suitable size to facilitate safe oper5 ations, including a suitable area to quar6 antine suspect prescription drug product; 

7 ‘‘(ii) maintaining adequate security; 

8 and 

9 ‘‘(iii) having written policies and pro10 cedures to— 

11 ‘‘(I) address receipt, security, stor12 age, inventory, shipment, and distribu13 tion of a prescription drug product; 

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

15 confirmed losses or thefts in the United 

16 States; 

17 ‘‘(III) correct errors and inac18 curacies in inventories; 

19 ‘‘(IV) provide support for manu20 facturer recalls; 

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

22 and address any reasonably foreseeable 

23 crisis that affects security or operation 

24 at the facility, such as a strike, fire, or 

25 flood; 

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1 ‘‘(VI) ensure that any expired 

2 prescription drug product is segregated 

3 from other prescription drug products 

4 and returned to the manufacturer or 

5 repackager or destroyed; 

6 ‘‘(VII) maintain the capability to 

7 electronically trace the receipt and out8 bound distribution of a prescription 

9 drug product, and supplies and records 

10 of inventory; and 

11 ‘‘(VIII) quarantine or destroy a 

12 suspect prescription drug product if di13 rected to do so by the respective manu14 facturer, wholesale distributor, dis15 penser, or an authorized government 

16 agency; 

17 ‘‘(E) provide for periodic inspection, as de18 termined by the Secretary, of such facility ware19 house space to ensure compliance with this sec20 tion; 

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

22 manager or designated representative anyone 

23 convicted of any felony violation of section 

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1 tion 1365 of title 18, United States Code, relat2 ing to prescription drug product tampering; 

3 ‘‘(G) perform mandatory background checks 

4 of the provider’s facility managers or designated 

5 representatives of such managers; 

6 ‘‘(H) require a third-party logistics pro7 vider to provide to the applicable licensing au8 thority, upon the authority’s request, a list of all 

9 prescription drug product manufacturers, whole10 sale distributors, and dispensers for whom the 

11 third-party logistics provider provides services at 

12 the provider’s facilities; and 

13 ‘‘(I) include procedures under which any 

14 third-party logistics provider license— 

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

16 years after issuance of the license; and 

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

18 year periods. 

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

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

21 logistics provider remains accredited by the Secretary, sub22 ject to renewal under subsection (d). If the Secretary finds 

23 that the third-party accreditation program demonstrates 

24 that all applicable requirements for licensure under this sec25 tion are met, the Secretary shall issue a license under this 

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1 section to a third-party logistics provider receiving accredi2 tation. 

3 ‘‘(g) QUALIFIED LICENSING PROGRAM DEFINED.—In 

4 this section, the term ‘qualified licensing program’ means 

5 a program meeting the requirements of this section and the 

6 regulations thereunder. 

7 ‘‘(h) EFFECTIVE DATE.—The requirements of this sec8 tion shall take effect not later than 1 year after the date 

9 of the enactment of this section. The Secretary shall issue 

10 the regulations required by subsection (d) not later than 

11 180 days after the date of the enactment of this section.’’. 

12 SEC. 6. PENALTIES. 

13 (a) PROHIBITED ACTS.—Section 301(t) of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 331(t)) is amend15 ed by striking ‘‘or the distribution of drugs in violation of 

16 section 503(e) or the failure to otherwise comply with the 

17 requirements of section 503(e)’’ and inserting ‘‘the failure 

18 to comply with any requirement of section 582, engaging 

19 in the wholesale distribution of a drug in violation of sec20 tion 583 or the failure to otherwise comply with the require21 ments of section 583, or engaging in the activities of a 

22 third-party logistics provider in violation of section 584 or 

23 the failure to otherwise comply with the requirements of sec24 tion 584’’. 

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1 (b) ENHANCED PENALTY FOR KNOWING UNLICENSED

2 ACTIVITIES.—Section 303(b)(1)(D) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 333(b)(1)(D)) is 

4 amended by striking ‘‘503(e)(2)(A)’’ and inserting ‘‘583 or 

5 584’’. 

6 (c) MISBRANDING.—Section 502 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 352) is amended by 

8 adding at the end the following: 

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

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

11 SEC. 7. UNIFORM NATIONAL POLICY. 

12 Subchapter H of chapter V of the Federal Food, Drug, 

13 and Cosmetic Act, as amended by section 5, is further 

14 amended by adding at the end the following: 

15 ‘‘SEC. 585. UNIFORM NATIONAL POLICY. 

16 ‘‘(a) PREEMPTION OF STATE PRESCRIPTION DRUG

17 PRODUCT TRACING AND OTHER REQUIREMENTS.—Begin18 ning on the date of the enactment of the Safeguarding 

19 America’s Pharmaceuticals Act of 2013, no State or polit20 ical subdivision of a State may establish or continue in ef21 fect any requirements for tracing drugs through the dis22 tribution system (including any requirements with respect 

23 to paper or electronic pedigrees, track and trace, statements 

24 of distribution history, transaction history, or transaction 

25 statements, or verification, investigation, disposition, alerts, 

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1 or recordkeeping relating to the pharmaceutical distribution 

2 supply chain system) that— 

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

4 or in addition to any requirements applicable under 

5 this Act; or 

6 ‘‘(2) are inconsistent with any applicable waiv7 er, exception, or exemption issued by the Secretary 

8 under section 582(a). 

9 ‘‘(b) STANDARDS OR LICENSURE.— 

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

11 enactment of Safeguarding America’s Pharma12 ceuticals Act of 2013, no State or political subdivision 

13 of a State may establish or continue any standards, 

14 requirements, or regulations with respect to wholesale 

15 drug distributor or third-party logistics provider li16 censure which are inconsistent with, less stringent 

17 than, in addition to, or more stringent than, the 

18 standards and requirements under this Act. 

19 ‘‘(2) LICENSING FEES.—Paragraph (1) does not 

20 affect the authority of a State to collect fees from 

21 wholesale drug distributors or third-party logistics 

22 providers in connection with State licensing under 

23 section 583 or 584 pursuant to a licensing program 

24 meeting the requirements of such sections. 

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1 ‘‘(3) ENFORCEMENT, SUSPENSION, AND REVOCA2 TION OF LICENSES.—Notwithstanding paragraph (1), 

3 a State— 

4 ‘‘(A) may take administrative action, in5 cluding fines, to enforce a licensure requirement 

6 promulgated by the State in accordance with 

7 this Act; 

8 ‘‘(B) may provide for the suspension or rev9 ocation of licenses issued by the State for viola10 tions of the laws of such State; 

11 ‘‘(C) upon conviction of a person for a vio12 lation of Federal, State, or local controlled sub13 stance laws or regulations, may provide for fines, 

14 imprisonment, or civil penalties; and 

15 ‘‘(D) may regulate activities of entities li16 censed pursuant to section 583 or 584 in a man17 ner that is consistent with the provisions of this 

18 subchapter.’’. 

19 SEC. 8 ELECTRONIC LABELING. 

20 (a) IN GENERAL.—Section 502(f) of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended by 

22 adding at the end the following new sentence: ‘‘Required 

23 labeling (other than immediate container or carton labels) 

24 that is intended for use by a physician, a pharmacist, or 

25 another health care professional, and that provides direcmstockstill on DSK4VPTVN1PROD with BILLS

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1 tions for human use of a drug subject to section 503(b)(1), 

2 may (except as necessary to mitigate a safety risk, as speci3 fied by the Secretary in regulation) be made available by 

4 electronic means instead of paper form, provided that such 

5 labeling complies with all applicable requirements of law, 

6 the manufacturer or distributor, as applicable, affords 

7 health care professionals and authorized dispensers (as de8 fined in section 581) the opportunity to request the labeling 

9 in paper form, and after such a request the manufacturer 

10 or distributor promptly provides the requested information 

11 without additional cost.’’. 

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

13 Human Services shall promulgate regulations imple14 menting the amendment made by subsection (a). 

15 (c) APPLICATION.—The last sentence of section 502(f) 

16 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 352(f)), as added by subsection (a), shall apply beginning 

18 on the earlier of— 

19 (1) the effective date of final regulations promul20 gated under subsection (b); or 

21 (2) the day that is 180 days after the date of en22 actment of this Act. 

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Union Calendar No. 65 

113TH CONGRESS 

1ST SESSION H. R. 1919 

[Report No. 113–93] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

tion supply chain, and for other purposes. Act with respect to the pharmaceutical distribuJUNE 3, 2013 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 

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