Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Preserving Patient Access to Compounded Medications Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to expand the circumstances under which a drug may be compounded (manufactured at small scale) to allow pharmacists and physicians to compound drugs for administration to patients in an office or clinical setting, in accordance with state law. (Drugs that are compounded do not need to meet certain federal requirements regarding manufacturing, labeling, or approval.) Dietary supplements may be used in the compounding of a drug. The bill exempts from interstate distribution limits the dispensing of a compounded drug from the facility where it is compounded to a patient or health facility. The scope of Food and Drug Administration (FDA) inspections of compounding pharmacies is limited to pertinent equipment, materials, containers, and labeling, which is the same scope as inspections of pharmacies. (Currently, the scope of inspections of compounding pharmacies is the same scope as inspections of drug manufacturers.) The bill eliminates the requirement for compounding pharmacies to register with the FDA as drug manufacturers.
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Health
Administrative law and regulatory proceduresBusiness recordsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationNutrition and dietPrescription drugs
To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes.
USA115th CongressHR-2871| House
| Updated: 6/16/2017
Preserving Patient Access to Compounded Medications Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to expand the circumstances under which a drug may be compounded (manufactured at small scale) to allow pharmacists and physicians to compound drugs for administration to patients in an office or clinical setting, in accordance with state law. (Drugs that are compounded do not need to meet certain federal requirements regarding manufacturing, labeling, or approval.) Dietary supplements may be used in the compounding of a drug. The bill exempts from interstate distribution limits the dispensing of a compounded drug from the facility where it is compounded to a patient or health facility. The scope of Food and Drug Administration (FDA) inspections of compounding pharmacies is limited to pertinent equipment, materials, containers, and labeling, which is the same scope as inspections of pharmacies. (Currently, the scope of inspections of compounding pharmacies is the same scope as inspections of drug manufacturers.) The bill eliminates the requirement for compounding pharmacies to register with the FDA as drug manufacturers.
Health Subcommittee, Energy and Commerce Committee
Health
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Administrative law and regulatory proceduresBusiness recordsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationNutrition and dietPrescription drugs