QUESTIONS AND ANSWERS SURE A+
✔✔Product Selection in WA - ✔✔Two-line prescription blank, out of state ok to
substitute unless "DAW" etc. is on Rx
-Commission rule (WAC 246-899-050) clarifies further. If prescriber does not clearly
indicate instructions, may substitute only if pharmacist
-Has personal knowledge of rules in the other state;
-Has obtained authorization from the prescriber; or
Obtains current information on the rules in the other state
Indicate on oral prescriptions if DAW or Substitution Permitted
Shall substitute unless patient requests otherwise
Must use therapeutically equivalent product of identical base or salt given in same
regimen
May use any reliable information source to determine bioequivalence
✔✔Therapeutic Substitution in WA - ✔✔May do "Therapeutic Substitution" based on
prior authorization from prescriber
-Protocol, formulary
-Per-prescription basis
Blanket prior authorization can be verbal, but are required to have documentation of
authorization in the pharmacy
Substitution using prescriptive authority protocol is not really product selection, but
prescribing
,RCW 69.41.100
✔✔Sales of syringes/needles in WA - ✔✔A retailer may sell syringes and needles if he
or she is satisfied that "the device will be used for the legal use intended." (RCW
70.115.050)
Lawful for any person over 18 to possess sterile hypodermic syringes and needles for
the purpose of reducing blood borne diseases. (RCW 69.50.412(5))
Nothing in the Drug Paraphernalia Act "prohibits legal distribution of injection syringe
equipment through public health and community based HIV prevention programs, and
pharmacies." (RCW 69.50.412(3))
Retailers not REQUIRED to sell syringes or needles to any person. (RCW 70.115.060)
✔✔Outsourcing facilities for pharmacy compounding - ✔✔Entities engaged in large
volume compounding, particularly of sterile products, voluntarily register with FDA
-Subject to cGMPs
-Exempt from NDA or adequate labeling requirements
-Subject to FDA inspection
-Subject to registration and inspection fees
Must be under supervision of a licensed pharmacist
✔✔Pharmacy compounding requirements - ✔✔For an identified individual patient
Based on the unsolicited receipt of a valid prescription
By a licensed pharmacist or a physician
Limited quantities may be compounded prior to receiving a prescription
Based on a history of the pharmacist receiving valid orders
Within an established relationship between the pharmacist, physician, and patient
✔✔Pharmacy compounding components and methods - ✔✔Must comply with USP or
NF monographs, if they exist, and the USP Chapter on Pharmacy Compounding.
If no monographs exist, are made from components of approved drugs, or
Are components that appear on a bulk ingredients list developed by FDA
Must be manufactured in an FDA registered facility
✔✔Pharmacy compounding prohibited products - ✔✔May not compound products that
are listed by FDA as having been removed from market due to lack of safety or efficacy
May not compound "regularly or in an inordinate amount" products that are essentially
copies of commercially available drug products.
May not compound products that are listed by FDA as having demonstrable difficulties
in compounding [list to be developed].
✔✔Pharmacy Compounding: Washington revisions to Pharmacy Practice Act [RCW
18.64.011 (16)] - ✔✔Distribution of a compounded product by a pharmacy for "resale" is
"manufacturing," not compounding.
-May be distributed for resale subject to approval by pharmacy commission (during
shortage, etc.)
, "Manufacturing" does NOT include: (is ok to do)
Office Use - Compounded by a pharmacy on order of licensed practitioner for use in
practitioner's professional practice for administration to patients;
Limited repackaging - Repackaging of commercially available medication in "small,
reasonable quantities" for office use by a practitioner;
Centralized compounding - Distribution of a compounded product to other appropriately
licensed entities under the ownership or control of the facility in which the compounding
takes place; or
Delivery - Delivery of finished and appropriately compounded products dispensed
pursuant to a prescription to "alternative delivery locations, other than the patient's
residence, when requested by the patient, or the prescriber to administer to the patient,
or to another licensed pharmacy to dispense to the patient.
USP chapters <795> and <797> incorporated into statute when compounding products
pursuant to a prescription
✔✔USP Guidelines
General chapter <795> (Non-sterile compounding) - ✔✔Applies to non-sterile
preparations
Expiration dating recommendations
-Non-aqueous liquids and solids
-6 months or 25% of mfr label if made from manufactured product
-Not greater than 6 months if USP or NF ingredient is source
-Aqueous: 14 days, stored in cold place
-All other: 30 days or intended duration of therapy
Sources
-USP or NF
-Manufactured product w/ lot #, exp date
✔✔USP Guidelines
General chapter <797> (sterile compounding) - ✔✔Applies to sterile products and
responsibilities of pharmacy personnel in their preparation
Identifies standards for:
-Low-risk, medium-risk, and high-risk sterile compounding
-Verification of accuracy and sterilization
-Training and evaluation in personnel aseptic skills
-Environmental quality and control
-Verification of automated devices for compounding parenteral nutrition therapy
-Finished product release checks and tests
-Storage and beyond-use dating
-Quality control post-dispensing and distribution
-Packaging, handling, storage and transport