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October 25, 2016
Stephanee Synnott, Ph.D.
Compliance Officer, Chemical Hazards Team
The views expressed in this presentati...
Customarily produced or distributed for sale for
consumption or use, or customarily stored, by
individuals in or about the...
 acetaminophen
 aspirin
 controlled drugs
 dibucaine
 diphenhydramine
 ibuprofen
 iron-containing drugs
and dietary...
 ethylene glycol
 fluoride
 furniture polish
 glue removers
containing acetonitrile
 hydrocarbons
 kindling and/or
i...
 Not Used in/Around the Household
o Institutional Use
 Hospitals, Nursing Homes
o Professional Use
 Prescription
o Bulk...
 OTCs - Household Products
o One size
o Labeled (16 CFR §1700.5)
 “This Package For Households Without Young
Children”
...
 Oral prescription drugs require special
packaging.
o 16 CFR § 1700.14(a)(10)
 Section 4(b) of the PPPA grants physician...
 The decision to provide special packaging is
up to the physician on a case by case basis.
 Section 4(b) does not apply ...
 Pure liquid nicotine when offered in a retail
package for sale to consumers
 Liquid nicotine diluted with Proplylene
Gl...
 Nicotine that is inaccessible
o Sealed, pre-filled, disposable cartridges meant for
e-cigarette
o disposable e-juice tan...
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PPPA Workshop - Substances Covered Presentation 2016

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Poison Prevention Packaging Act - Substances Covered by the PPPA and the CNPPA

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PPPA Workshop - Substances Covered Presentation 2016

  1. 1. October 25, 2016 Stephanee Synnott, Ph.D. Compliance Officer, Chemical Hazards Team The views expressed in this presentation are those of the CPSC staff, have not been reviewed or approved by, and may not necessarily reflect the views of, the Commission.
  2. 2. Customarily produced or distributed for sale for consumption or use, or customarily stored, by individuals in or about the household and which are- A. A hazardous substance as defined by the Federal Hazardous Substances Act (FHSA); B. Foods, Drugs, or Cosmetics as defined by the Federal Food, Drug, and Cosmetics Act (FD&CA); or C. Substances intended for use as a fuel when stored in a portable container and used in the heating, cooking, or refrigeration system of a house. 15 U.S.C. § 1471(2) 2
  3. 3.  acetaminophen  aspirin  controlled drugs  dibucaine  diphenhydramine  ibuprofen  iron-containing drugs and dietary supplements  ketoprofen  lidocaine  loperamide  methyl salicylate  minoxidil  mouthwash  naproxen  oral prescription drugs  OTC switch drugs  imidazolines 3
  4. 4.  ethylene glycol  fluoride  furniture polish  glue removers containing acetonitrile  hydrocarbons  kindling and/or illuminating preparations  methacrylic acid  methyl alcohol  mouthwash containing ethanol  permanent wave neutralizer containing sodium or potassium bromate  sodium and potassium hydroxide  solvents for paint or other coating material  sulfuric acid  turpentine 4
  5. 5.  Not Used in/Around the Household o Institutional Use  Hospitals, Nursing Homes o Professional Use  Prescription o Bulk Drugs Repackaged by the Pharmacist o Requested by Patient or Physician  Section 4 allows limited use of non-complying packaging 15 U.S.C. § 1473 o Exempted (16 CFR § 1702)  16 CFR §1700.14(a)(10)(i)-(xxi) 5
  6. 6.  OTCs - Household Products o One size o Labeled (16 CFR §1700.5)  “This Package For Households Without Young Children” “Package Not Child-Resistant” o Other popular sizes are CR o Imposed exclusive CR  Drain cleaners (16 CFR 1500.17(a)(4)) 6
  7. 7.  Oral prescription drugs require special packaging. o 16 CFR § 1700.14(a)(10)  Section 4(b) of the PPPA grants physicians the authority to order non-CR packaging for their patients in the written prescription.  The Commission’s policy is to not require manufacturers of regulated prescription drug samples to provide the samples in special packaging. o 49 Fed. Reg. 8008 (March 5, 1984) 7
  8. 8.  The decision to provide special packaging is up to the physician on a case by case basis.  Section 4(b) does not apply to regulated over-the-counter (OTC) drugs because they are not dispensed by the order of a licensed practitioner.  Samples of regulated OTC drugs must be packaged in special packaging. 8
  9. 9.  Pure liquid nicotine when offered in a retail package for sale to consumers  Liquid nicotine diluted with Proplylene Glycol/Vegetable Glycerin (PG/VG) base liquid to be used in e-liquid manufacture  E-juice or E-liquid (mixture of liquid nicotine, PG/VG base, and flavoring) 9
  10. 10.  Nicotine that is inaccessible o Sealed, pre-filled, disposable cartridges meant for e-cigarette o disposable e-juice tanks  Packages containing only PG/VG and/or flavor extract  Empty packages or closures that are sold as an after-market product o Non-special packaging closures may NOT be packaged together with a liquid nicotine product for retail sale  Products not intended to be sold “as-is” to consumers o Products that hold 5 gallons or more 10

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