I 

112TH CONGRESS 

1ST SESSION H. R. 2227 

To amend the Federal Food, Drug, and Cosmetic Act to provide for the 

regulation of medical gases, taking into account the special characteristics 

of medical gases, the special techniques and processes required to produce 

medical gases, and the established history of safe and effective use 

of medical gases. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 16, 2011 

Mr. LANCE (for himself and Mr. MURPHY of Connecticut) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

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

provide for the regulation of medical gases, taking into 

account the special characteristics of medical gases, the 

special techniques and processes required to produce 

medical gases, and the established history of safe and 

effective use of medical gases. 

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; TABLE OF CONTENTS. 

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

5 ‘‘Medical Gas Safety Act’’. 


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

2 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Regulation of medical gases. 

Sec. 4. Fees relating to medical gas regulation. 

Sec. 5. Miscellaneous provisions. 

3 SEC. 2. FINDINGS. 

4 The Congress finds the following: 

5 (1) Medical gases have been used broadly by 

6 the medical community for many decades and are 

7 critical to ensuring the public health. 

8 (2) Most medical gases predate the new drug 

9 approval provisions in the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 301 et seq.) and, con11 sequently, medical gases have been marketed for 

12 many years without new drug approval. 

13 SEC. 3. REGULATION OF MEDICAL GASES. 

14 (a) ADULTERATION.— 

15 (1) IN GENERAL.—Section 501(a)(2) of the 

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

17 351(a)(2)) is amended by striking ‘‘; or (3)’’ and in18 serting ‘‘; or (D) if it is a medical gas (as defined 

19 in section 575) and it is manufactured, prepared, 

20 processed, packed, or held in violation of subchapter 

21 G or regulations thereunder; or (3)’’. 


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1 (2) APPLICABILITY.—The amendment made by 

2 paragraph (1) applies beginning on the date that is 

3 2 years after the date of the enactment of this Act. 

4 (b) REGULATION.—Chapter V of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend6 ed by adding at the end the following: 

7 ‘‘Subchapter G—Medical Gases 

8 ‘‘SEC. 575. DEFINITIONS. 

9 ‘‘In this subchapter: 

10 ‘‘(1) The term ‘designated medical gas’ means 

11 any of the following: 

12 ‘‘(A) Oxygen, as defined in the United 

13 States Pharmacopeia (or any successor publica14 tion). 

15 ‘‘(B) Nitrogen, as defined in the National 

16 Formulary (or any successor publication). 

17 ‘‘(C) Nitrous oxide, as defined in the 

18 United States Pharmacopeia (or any successor 

19 publication). 

20 ‘‘(D) Carbon dioxide, as defined in the 

21 United States Pharmacopeia (or any successor 

22 publication). 

23 ‘‘(E) Helium, as defined in the United 

24 States Pharmacopeia (or any successor publica25 tion). 


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1 ‘‘(F) Medical air, as defined in the United 

2 States Pharmacopeia (or any successor publica3 tion). 

4 ‘‘(G) Any other medical gas deemed appro5 priate by the Secretary. 

6 ‘‘(2) The term ‘medical gas’ means a drug that 

7 is— 

8 ‘‘(A) manufactured or stored in a liquefied, 

9 non-liquefied, or cryogenic state; and 

10 ‘‘(B) is administered as a gas. 

11 ‘‘(3) The term ‘Medical Gas Advisory Com12 mittee’ means the Medical Gas Advisory Committee 

13 established under section 577. 

14 ‘‘(4) The term ‘medical gas manufacturer’ 

15 means an entity that owns or operates an establish16 ment registered under section 510 that manufac17 tures, prepares, processes, packages, repackages, or 

18 labels a medical gas or that fills high-pressure med19 ical gas cylinders or cryogenic medical gas con20 tainers by any of the following methods: liquid to liq21 uid, liquid to gas, or gas to gas. 

22 ‘‘SEC. 576. REGULATION OF MEDICAL GASES. 

23 ‘‘(a) CERTIFICATION OF DESIGNATED MEDICAL

24 GASES.— 


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1 ‘‘(1) SUBMISSION.—Any person may file with 

2 the Secretary a certification that a medical gas is a 

3 designated medical gas. 

4 ‘‘(2) APPROVAL OF CERTIFICATION.—The Sec5 retary shall approve a certification submitted under 

6 paragraph (1) with respect to a medical gas if the 

7 certification demonstrates to the Secretary’s satis8 faction that the medical gas is a designated medical 

9 gas. 

10 ‘‘(3) EFFECT OF APPROVAL OF CERTIFI11 CATION.— 

12 ‘‘(A) IN GENERAL.—A medical gas subject 

13 to a certification for which an approval is in ef14 fect under paragraph (2) is deemed to be ap15 proved pursuant to an application filed pursu16 ant to section 505(b) or 512(b)(1), as applica17 ble, for— 

18 ‘‘(i) those indications for which the 

19 medical gas has been marketed to a mate20 rial extent for a material time; or 

21 ‘‘(ii) for administration in a super22 vised clinical setting under the direction of 

23 a medical or veterinary, as applicable, pro24 fessional. 


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1 ‘‘(B) INAPPLICABILITY OF EXCLUSIVITY

2 PROVISIONS.—Sections 505(c)(3)(E), 

3 505(j)(5)(F), and 512(c)(2)(F) do not apply 

4 with respect to the approval of a designated 

5 medical gas under this subsection. 

6 ‘‘(4) REGISTRATION AND LISTING UNDER SEC7 TION 510.—To the greatest extent possible, the Sec8 retary shall streamline the certification and approval 

9 process under this subsection with the registration 

10 and listing process under section 510. 

11 ‘‘(b) APPROVAL OF NON-DESIGNATED MEDICAL

12 GASES.— 

13 ‘‘(1) PROCEDURES.—Not later than 2 years 

14 after the date of the enactment of this subchapter, 

15 the Secretary, in consultation with the Medical Gas 

16 Advisory Committee, shall establish by rule appro17 priate procedures for the approval of medical gases 

18 that are not designated medical gases pursuant to 

19 section 505 or 512, as applicable. 

20 ‘‘(2) SUBMISSION OF NEW DRUG APPLICATIONS

21 AND ABBREVIATED NEW DRUG APPLICATIONS.— 

22 ‘‘(A) IN GENERAL.—Except as provided in 

23 subparagraph (B), the Secretary shall not re24 quire the submission of a new drug application 

25 or an abbreviated new drug application under 


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1 subsection (b) or (j) of section 505, or a new 

2 animal drug application or an abbreviated new 

3 animal drug application under subsection (b)(1) 

4 or (b)(2) of section 512, for any medical gas 

5 that is not a designated medical gas during the 

6 period ending on the later of— 

7 ‘‘(i) 4 years after the date of the en8 actment of this subchapter; or 

9 ‘‘(ii) 2 years after the date on which 

10 the Secretary establishes applicable proce11 dures under paragraph (1). 

12 ‘‘(B) EXCEPTIONS.—Nothing in this sub13 chapter— 

14 ‘‘(i) prohibits the voluntary submis15 sion of an application under subsection (b) 

16 or (j) of section 505 or subsection (b)(1) 

17 or (b)(2) of section 512 for a medical gas; 

18 or 

19 ‘‘(ii) constitutes an exemption from 

20 the requirements under section 505(i) or 

21 section 512(j) (relating to investigational 

22 new drugs and investigational new animal 

23 drugs, respectively). 

24 ‘‘(c) SEPARATE REGULATIONS FOR MEDICAL

25 GASES.— 


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

2 after the date of the enactment of this subchapter, 

3 the Secretary, in consultation with the Medical Gas 

4 Advisory Committee, shall establish by separate and 

5 specific regulation— 

6 ‘‘(A) appropriate current good manufac7 turing practice requirements for medical gases; 

8 ‘‘(B) separate labeling requirements for 

9 medical gases; 

10 ‘‘(C) separate wholesale distribution re11 quirements for medical gases; 

12 ‘‘(D) a streamlined electronic process for 

13 registration, and listing of medical gases, under 

14 section 510 by medical gas manufacturers that 

15 are small business concerns (as defined in sec16 tion 3 of the Small Business Act); and 

17 ‘‘(E) separate and proportionate product 

18 tracking and anticounterfeiting rules for med19 ical gases. 

20 ‘‘(2) EVALUATION IN RULEMAKING.—In any 

21 regulation of the Food and Drug Administration 

22 pertaining to drugs or drug manufacturers that is 

23 pending finalization as of the date of the enactment 

24 of this subchapter or is proposed after such date, the 

25 Secretary shall specifically evaluate the effect of 


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1 such regulation on, and the suitability of such regu2 lation for, medical gases and medical gas manufac3 turers. Based on such evaluation, the Secretary shall 

4 include in the regulation an accommodation, unique 

5 application, or exemption for medical gases and 

6 medical gas manufacturers as appropriate given the 

7 special characteristics of medical gases. 

8 ‘‘(3) COORDINATION WITH STATES.— 

9 ‘‘(A) IN GENERAL.—The Secretary, in con10 sultation with the Medical Gas Advisory Com11 mittee, shall establish a separate risk-based in12 spection regime specific to medical gas manu13 facturers that ensures coordination with State 

14 and local inspection activities and seek to enter 

15 into partnership agreements in order to improve 

16 the coordination and efficiency of Federal and 

17 State efforts to regulate medical gas manufac18 turers and medical gases. Such agreements 

19 shall— 

20 ‘‘(i) ensure consistent inspector train21 ing between State and Federal authorities; 

22 ‘‘(ii) eliminate, to the extent prac23 ticable, any overlapping fees or inspection 

24 fees or activities between State and Fed25 eral inspectors; 


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1 ‘‘(iii) promote current good manufac2 turing practice compliance; 

3 ‘‘(iv) ensure consistent application of 

4 Federal regulations with respect to medical 

5 gas manufacturers; and 

6 ‘‘(v) include any mechanisms deter7 mined by the Secretary, in consultation 

8 with the Medical Gas Advisory Committee, 

9 to improve the coordination and efficiency 

10 of Federal and State efforts to regulate 

11 medical gas manufacturers and medical 

12 gases. 

13 ‘‘(B) DISSEMINATION OF INFORMATION.— 

14 The Secretary shall disseminate appropriate in15 formation to States regarding application of 

16 Federal regulations to medical gas manufactur17 ers and medical gases in order to improve the 

18 consistency of enforcement of applicable regula19 tions. 

20 ‘‘SEC. 577. MEDICAL GAS ADVISORY COMMITTEE. 

21 ‘‘(a) ESTABLISHMENT.—Not later than 6 months 

22 after the date of the enactment of this subchapter, the 

23 Secretary shall establish a permanent advisory committee 

24 to be known as the Medical Gas Advisory Committee. 


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1 ‘‘(b) MEMBERSHIP.—The Medical Gas Advisory 

2 Committee— 

3 ‘‘(1) shall include representatives of medical gas 

4 manufacturers and medical gas safety standards de5 velopment organizations; and 

6 ‘‘(2) may include representatives of patient ad7 vocacy groups, professional associations, physicians, 

8 scientists, other medical professionals licensed to 

9 manufacture or use medical gases (such as 

10 pulmonologists, respiratory therapists, veterinarians, 

11 and anesthesiologists), and other stakeholders as de12 termined appropriate by the Secretary. 

13 ‘‘(c) DUTIES.—The Medical Gas Advisory Committee 

14 shall provide the Secretary with regular guidance and spe15 cific advice on medical gas regulatory initiatives, including 

16 with respect to regulations concerning the approval of 

17 medical gases under sections 505 and 512, the manufac18 ture of medical gases, and related activities. 

19 ‘‘(d) FACA.—Except as inconsistent with this sec20 tion, the Medical Gas Advisory Committee shall be subject 

21 to the Federal Advisory Committee Act.’’. 

22 SEC. 4. FEES RELATING TO MEDICAL GAS REGULATION. 

23 (a) FINDING.—The Congress finds that the fees au24 thorized by the amendment made in subsection (b) will 

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1 ministration’s regulation of non-designated medical gases, 

2 as set forth in the goals identified for purposes of part 

3 6 of subchapter C of chapter VII of the Federal Food, 

4 Drug, and Cosmetic Act, in the letters from the Secretary 

5 of Health and Human Services to the Chairman of the 

6 Committee on Health, Education, Labor, and Pensions of 

7 the Senate and the Chairman of the Committee on Energy 

8 and Commerce of the House of Representatives, as set 

9 forth in the Congressional Record. 

10 (b) AUTHORITY TO ASSESS AND COLLECT FEES.— 

11 Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is 

12 amended by adding at the end the following: 

13 ‘‘PART 6—FEES RELATING TO MEDICAL GASES 

14 ‘‘SEC. 744. AUTHORITY TO ASSESS AND COLLECT FEES. 

15 ‘‘(a) FEES RELATING TO NON-DESIGNATED MED16 ICAL GASES.—For fiscal year 2013 and each subsequent 

17 fiscal year, the Secretary, in consultation with the Medical 

18 Gas Advisory Committee, shall assess and collect fees 

19 under this section from each category of persons that, with 

20 respect to drugs that are non-designated medical gases, 

21 would be subject to a fee under section 736(a), 740(a), 

22 or 741(a) but for the operation of subsection (c). 

23 ‘‘(b) EXEMPTION FOR DESIGNATED MEDICAL

24 GASES.—Subsection (a) does not authorize the assessment 


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1 or collection of any fee with respect to drugs that are des2 ignated medical gases. 

3 ‘‘(c) INAPPLICABILITY OF OTHER DRUG FEES TO

4 MEDICAL GASES.—Fees under sections 736(a), 740(a), 

5 and 741(a) shall not be assessed or collected insofar as 

6 such fees relate to drugs that are medical gases. 

7 ‘‘(d) ESTABLISHMENT.—The Secretary shall by regu8 lation establish the amount of fees under this section for 

9 a fiscal year— 

10 ‘‘(1) so as to generate a total revenue amount 

11 not exceeding the Secretary’s estimate of 100 per12 cent of the costs of the Food and Drug Administra13 tion’s regulation of non-designated medical gases 

14 during such year; and 

15 ‘‘(2) taking into consideration the special char16 acteristics of non-designated medical gases, includ17 ing the unique manufacturing and distribution sys18 tem required to produce non-designated medical 

19 gases. 

20 ‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 

21 ‘‘(1) IN GENERAL.—Fees authorized under sub22 section (a) shall be collected and available for obliga23 tion only to the extent and in the amount provided 

24 in advance in appropriations Acts. Such fees are au25 thorized to remain available until expended. Such 


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1 sums as may be necessary may be transferred from 

2 the Food and Drug Administration salaries and ex3 penses appropriation account without fiscal year lim4 itation to such appropriation account for salaries 

5 and expenses with such fiscal year limitation. The 

6 sums transferred shall be available solely for the 

7 costs of the Food and Drug Administration’s regula8 tion of non-designated medical gases. 

9 ‘‘(2) COLLECTIONS AND APPROPRIATION

10 ACTS.— 

11 ‘‘(A) IN GENERAL.—The fees authorized 

12 by this section— 

13 ‘‘(i) shall be retained in each fiscal 

14 year in an amount not to exceed the 

15 amount specified in appropriation Acts, or 

16 otherwise made available for obligation, for 

17 such fiscal year; and 

18 ‘‘(ii) shall only be collected and avail19 able to pay the costs of the Food and Drug 

20 Administration’s regulation of non-des21 ignated medical gases. 

22 ‘‘(B) COMPLIANCE.—The Secretary shall 

23 be considered to have met the requirements of 

24 subparagraph (A)(ii) in any fiscal year if the 

25 costs funded by appropriations and allocated for 


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1 the costs of the Food and Drug Administra2 tion’s regulation of non-designated medical 

3 gases— 

4 ‘‘(i) are not more than 3 percent 

5 below the level specified in subparagraph 

6 (A)(ii); or 

7 ‘‘(ii)(I) are more than 3 percent below 

8 the level specified in subparagraph (A)(ii), 

9 and fees assessed for the fiscal year fol10 lowing the subsequent fiscal year are de11 creased by the amount in excess of 3 per12 cent by which such costs fell below the 

13 level specified in such subparagraph; and 

14 ‘‘(II) such costs are not more than 5 

15 percent below the level specified in such 

16 subparagraph. 

17 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

18 For each of the fiscal years 2013 through 2017, 

19 there is authorized to be appropriated for fees under 

20 this section an amount equal to the total revenue 

21 amount determined under subsection (d) for the fis22 cal year. 

23 ‘‘(4) OFFSET.—If the sum of the cumulative 

24 amount of fees collected under this section for the 

25 fiscal years 2013 through 2015 and the amount of 


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1 fees estimated to be collected under this section for 

2 fiscal year 2016 exceeds the cumulative amount ap3 propriated under paragraph (3) for the fiscal years 

4 2013 through 2016, the excess shall be credited to 

5 the appropriation account of the Food and Drug Ad6 ministration as provided in paragraph (1), and shall 

7 be subtracted from the amount of fees that would 

8 otherwise be authorized to be collected under this 

9 section pursuant to appropriation Acts for fiscal 

10 year 2017. 

11 ‘‘(f) DEFINITIONS.—In this section: 

12 ‘‘(1) The terms ‘designated medical gas’ and 

13 ‘medical gas’ have the meanings given to such terms 

14 in section 575. 

15 ‘‘(2) The term ‘non-designated medical gas’ 

16 means a medical gas that is not a designated med17 ical gas.’’. 

18 (c) REAUTHORIZATION; REPORTING REQUIRE19 MENTS.—Part 6 of subchapter C of chapter VII (21 

20 U.S.C. 379f et seq.), as added by subsection (a), is further 

21 amended by adding at the end the following: 

22 ‘‘SEC. 744A. REAUTHORIZATION; REPORTING REQUIRE23 MENTS. 

24 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 

25 year 2013, not later than 120 days after the end of each 


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1 fiscal year for which fees are collected under this part, 

2 the Secretary shall prepare and submit to the Committee 

3 on Energy and Commerce of the House of Representatives 

4 and the Committee on Health, Education, Labor, and 

5 Pensions of the Senate a report concerning the progress 

6 of the Food and Drug Administration in achieving the 

7 goals identified in the letters described in section 4(a) of 

8 the Medical Gas Safety Act during such fiscal year and 

9 the future plans of the Food and Drug Administration for 

10 meeting the goals. 

11 ‘‘(b) FISCAL REPORT.—Beginning with fiscal year 

12 2013, not later than 120 days after the end of each fiscal 

13 year for which fees are collected under this part, the Sec14 retary shall prepare and submit to the Committee on En15 ergy and Commerce of the House of Representatives and 

16 the Committee on Health, Education, Labor, and Pen17 sions of the Senate a report on the implementation of the 

18 authority for such fees during such fiscal year and the 

19 use, by the Food and Drug Administration, of the fees 

20 collected for such fiscal year. 

21 ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 

22 make the reports required under subsections (a) and (b) 

23 available to the public on the Internet Web site of the 

24 Food and Drug Administration. 

25 ‘‘(d) REAUTHORIZATION.— 


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1 ‘‘(1) CONSULTATION.—In developing rec2 ommendations to present to the Congress with re3 spect to the goals, and plans for meeting the goals, 

4 for the Food and Drug Administration’s regulation 

5 of non-designated medical gases for the first 5 fiscal 

6 years after fiscal year 2017, and for the reauthoriza7 tion of this part for such fiscal years, the Secretary 

8 shall consult with— 

9 ‘‘(A) the Committee on Energy and Com10 merce of the House of Representatives; 

11 ‘‘(B) the Committee on Health, Education, 

12 Labor, and Pensions of the Senate; 

13 ‘‘(C) scientific and academic experts; 

14 ‘‘(D) health care professionals; 

15 ‘‘(E) representatives of patient and con16 sumer advocacy groups; and 

17 ‘‘(F) the regulated industry. 

18 ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning 

19 negotiations with the regulated industry on the reau20 thorization of this part, the Secretary shall— 

21 ‘‘(A) publish a notice in the Federal Reg22 ister requesting public input on the reauthoriza23 tion; 

24 ‘‘(B) hold a public meeting at which the 

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1 tion, including specific suggestions for changes 

2 to the goals referred to in subsection (a); 

3 ‘‘(C) provide a period of 30 days after the 

4 public meeting to obtain written comments from 

5 the public suggesting changes to this part; and 

6 ‘‘(D) publish the comments on the Food 

7 and Drug Administration’s Internet Web site. 

8 ‘‘(3) PERIODIC CONSULTATION.—Not less fre9 quently than once every month during negotiations 

10 with the regulated industry, the Secretary shall hold 

11 discussions with representatives of patient and con12 sumer advocacy groups to continue discussions of 

13 their views on the reauthorization and their sugges14 tions for changes to this part as expressed under 

15 paragraph (2). 

16 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA17 TIONS.—After negotiations with the regulated indus18 try, the Secretary shall— 

19 ‘‘(A) present the recommendations devel20 oped under paragraph (1) to the Congressional 

21 committees specified in such paragraph; 

22 ‘‘(B) publish such recommendations in the 

23 Federal Register; 


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1 ‘‘(C) provide for a period of 30 days for 

2 the public to provide written comments on such 

3 recommendations; 

4 ‘‘(D) hold a meeting at which the public 

5 may present its views on such recommenda6 tions; and 

7 ‘‘(E) after consideration of such public 

8 views and comments, revise such recommenda9 tions as necessary. 

10 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

11 Not later than January 15, 2017, the Secretary 

12 shall transmit to the Congress the revised rec13 ommendations under paragraph (4), a summary of 

14 the views and comments received under such para15 graph, and any changes made to the recommenda16 tions in response to such views and comments. 

17 ‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 

18 ‘‘(A) PUBLIC AVAILABILITY.—Before pre19 senting the recommendations developed under 

20 paragraphs (1) through (5) to the Congress, the 

21 Secretary shall make publicly available, on the 

22 public Web site of the Food and Drug Adminis23 tration, minutes of all negotiation meetings con24 ducted under this subsection between the Food 


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1 and Drug Administration and the regulated in2 dustry. 

3 ‘‘(B) CONTENT.—The minutes described 

4 under subparagraph (A) shall summarize any 

5 substantive proposal made by any party to the 

6 negotiations as well as significant controversies 

7 or differences of opinion during the negotiations 

8 and their resolution.’’. 

9 (d) SUNSET DATES.— 

10 (1) AUTHORIZATION.—The amendment made 

11 by subsection (b) ceases to be effective October 1, 

12 2017. 

13 (2) REPORTING REQUIREMENTS.—The amend14 ment made by subsection (c) ceases to be effective 

15 January 31, 2018. 

16 SEC. 5. MISCELLANEOUS PROVISIONS. 

17 (a) RULE OF CONSTRUCTION.—Nothing in this Act 

18 and the amendments made by this Act shall be construed 

19 to impair any approval of an application submitted under 

20 section 505 or 512 of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 355) for a medical gas (as defined 

22 in section 575 of the Federal Food, Drug, and Cosmetic 

23 Act, as added by section 3(b) of this Act) that occurred 

24 prior to the date of the enactment of this Act. 


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1 (b) SAVINGS CLAUSE.—Except as expressly set forth 

2 in this Act and the amendments made by this Act, a med3 ical gas (as defined in section 575 of the Federal Food, 

4 Drug, and Cosmetic Act, as added by section 3(b) of this 

5 Act) shall be subject to all applicable requirements for 

6 drugs under the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 301 et seq.). 

Æ 


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