Affordable Care Act and FDA Regulatory Information

Affordable Care Act of 2010

FDA Regulatory Information

Patient Protection and Affordable Care Act (PPACA) of 2010

906 Pages

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Affordable Care Act (ACA 6004)

ACA 6004 Legislation

SEC. 6004. PRESCRIPTION DRUG SAMPLE TRANSPARENCY.

Part A of title XI of the Social Security Act (42 U.S.C. 1301 et seq.), as amended by section 6002, is amended by inserting after section 1128G the following new section:

‘SEC. 1128H. REPORTING OF INFORMATION RELATING TO DRUG SAMPLES.

`(a) In General- Not later than April 1 of each year (beginning with 2012), each manufacturer and authorized distributor of record of an applicable drug shall submit to the Secretary (in a form and manner specified by the Secretary) the following information with respect to the preceding year:

`(1) In the case of a manufacturer or authorized distributor of record which makes distributions by mail or common carrier under subsection (d)(2) of section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353), the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by–

`(A) the name, address, professional designation, and signature of the practitioner making the request under subparagraph (A)(i) of such subsection, or of any individual who makes or signs for the request on behalf of the practitioner; and

`(B) any other category of information determined appropriate by the Secretary.

`(2) In the case of a manufacturer or authorized distributor of record which makes distributions by means other than mail or common carrier under subsection (d)(3) of such section 503, the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by–

`(A) the name, address, professional designation, and signature of the practitioner making the request under subparagraph (A)(i) of such subsection, or of any individual who makes or signs for the request on behalf of the practitioner; and

`(B) any other category of information determined appropriate by the Secretary.

`(b) Definitions- In this section:

`(1) APPLICABLE DRUG- The term `applicable drug’ means a drug–

`(A) which is subject to subsection (b) of such section 503; and

`(B) for which payment is available under title XVIII or a State plan under title XIX or XXI (or a waiver of such a plan).

`(2) AUTHORIZED DISTRIBUTOR OF RECORD- The term `authorized distributor of record’ has the meaning given that term in subsection (e)(3)(A) of such section.

`(3) MANUFACTURER- The term `manufacturer’ has the meaning given that term for purposes of subsection (d) of such section.’.

  • Bioequivalence Recommendations for Specific Products
    • http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm
  • Drug Compliance Programs
    • http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm252671.htm
  • Guidances (Drugs)
    • http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
  • Newly Added Guidance Documents
    • http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm
  • Nicotine-Containing Products
    • http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm345928.htm
  • Notice to Industry: Postmarketing Requirements – Postmarket studies and clinical trials
    • http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm292758.htm
  • Regulatory Guidance Drug Registration and Listing
    • http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm084014.htm
  • Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval
    • http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm
  • Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
    • http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm

Affordable Care Act (ACA) 6004 ACA Industry Submission Specifications User Guide

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cGMP for Finished Pharmaceuticals (21 CFR Part 211)

  • Download at http://www.gpo.gov/fdsys/pkg/CFR-2013-title21-vol4/pdf/CFR-2013-title21-vol4-part211.pdf

Investigations Operations Manual (IOM)

The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors.

  • Download at http://www.fda.gov/iceci/inspections/iom/default.htm

Compliance Program Guidance Manual (CPGM)

FDA’s Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA.

Compliance Programs do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used as long as the approach satisfies the requirements of the applicable statutes and regulations. FDA’s Compliance Programs are organized by the following program areas.

  • Read more at http://www.fda.gov/iceci/compliancemanuals/complianceprogrammanual/default.htm

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Last Updated: 2015-09-03