The Prescription - Packaging

Question 1

Information Required on Packaging Label? (List Data Elements)

Answer 1

1) Date Dispensed

2) Pharmacy Name, Address, Phone #, Dispensing RPh Initials

3) Prescriber Name

4) Patient Name (If Patient is an Animal: Name of Owner + Animal Name/Species)
* EXCEPT: EpiPen, Opioids Antagonists, Expedited Partner Therapy, Bronchodilator Canisters/Spacers

5) Prescription #, Drug Name, Strength, Quanitity, Directions, Precautions

6) Must List Any Substition:
* Brand to Generic Substitution Label:
“(generic name) generic for (brand name)”
* Generic to Brand Susbtitution Label:
“(brand name) brand for (generic name)”
* Interchangeable Biological Substitution Label:
“(interchangeable biologic product) interchangeable for (biologic product)”

Question 2

OTC Packaging Label Requirements

Answer 2

• Principal Display Label: Main Label Area (clear)
  1) If Side of Rectangle Package Is Display Area:
  Ht x W
  2) If Cylindrical:
  40% of Ht x Circumferance (C = 2 PI R)
  3) Any Other Shape:
  40% Total Surface or Entire Top Surface if Obvious
• Statement of ID: What Product Is
• Declaration of Net Quanity: Product Amount
• Pregnancy/Breastfeeding Warning: If Use Is Safe
• Sodium Labeling: If Applicable
  1) Salt is Not Synonymous with Term Sodium
  2) Rectal Labeling: (> 5 mg)
  Must Be Present If Dose Contains 5+ mg of Sodium (If Under 1 g: Use mg)
  3) Sodium Free (< 5 mg / 0 mg)
  Max Daily Dose Under 5 mg &
  Max Sodium Amount per Dosage Unit is 0 mg
  4) Very Low Sodium (< 35 mg)
  Max Daily Dose Under 35 mg
  5) Low Sodium (< 140 mg)
  Max Daily Dose Under 140 mg
  6) Sodium Warning (>140 mg)
  Max Daily Dose Over 140 mg

Question 3

Child Safety Cap Packaging Requirements

Answer 3

Commission Has Determined Degree of Hazard to Children: Special Packaging is Permitted for Several Over-the-Counter, Prescription, and Household Items. Goal: difficult for kids, easy for adults.

Child-Resistant If Difficult to Open Under 5 y/o:
* 200 Kids + Without Instructions = 85% Can’t Open
* 200 Kids + With Instructions = 80% Can’t Open
* Unit Packaging = 80% Can’t Open

Senior-Adult Use Effectiveness (SAUE): 90% Open

If Aerosol/Metal - Young Adult Test: 90% Open
Criteria for Need for Metal or Aerosol Container:
1) Other packaging types won’t comply w/ regulations
2) Other packaging types can’t be used for application
3) Other packaging/metal closure incompatible w/ Rx
4) Other packaging types can’t provide adequate shelf life
5) Any other reason. If previously marketed in nonmetal package/closure - presumed to not require metal.
(Provided if Commission Asks - Absent from SAUE)

Question 4

Packaging Expiration/Beyond-Use Date?

Answer 4

Unit Dose Dispensing Systems -
Expiration dating for nonsterile drugs repackaged into single unit, unit dose, or unit of issue packages must:
* Avoid Repackaging OR Make Exp. Less Than 90 Days IF Stability Issues Are Known
* Don’t Exceed Manufacturer’s OG Exp. Date
* Don’t Exceed 90 Days from Date of Repackaging Unless:
1) Class A or Class B Container for Solid Dosages / Tight Container for Liquid Dosages (Classified Under USP General Chapter 671)
2) Light Sensitive Container
(Classified as Sensitive to Light Label by Manufacturer)
3) Expiration Date is Less Than 12 Months

Patient Med Packs Expiration Date:
* 60 Days After Preparation