Download Pharmacy Issues: 2004 - Colorado Veterinary Medical Association

Pharmacy Issues: 2004
®
Elizabeth Curry-Galvin, DVM
Assistant Director, Scientific Activities
AVMA-Schaumburg
[email protected]
Pharmacy Issues: 2004
®
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Topics
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Compounding
Ethical Products
Internet Pharmacies
Context
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Business
Legal
Ethical
Reminder
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Allegations, No Names
Policy vs. Not
State laws and rules
vary-check Colorado
What’s Compounding?
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Definition
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Fills a niche
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Simply, the preparation of custom medication for a
particular patient (manipulation--> unapproved drug)
Pharmacists or Veterinarians
No drug approved for condition
Approved drug needs modification
Examples
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Mixing two pre-anesthetics
Tablets into suspension
Diluting
Flavoring
Be Precise
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Avoid generalizing when discussing “compounding”
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DRUG
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VCPR
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Custom medication prescribed for one animal vs. purchases
outside of a VCPR
SCALE
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Approved drug (AMDUCA) vs. bulk drug [raw drug ingredient or
chemical] (not legal)
Individual animal (compounding) vs. manufacturing / wholesaling
(piracy)
ANIMAL
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Food vs. non-food animal (different risks, differences in regulatory
discretion)
2 Compounding Issues
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Address Piracy
 Compounding from bulk drugs is not legal
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Need regulatory discretion from states and FDA
when veterinarians compound medically
necessary drugs from bulk ingredients for
individual, non-food animals, within a VCPR
because no drug is approved and available to
adequately treat the patient.
“Piracy” (manufacturing
unapproved drugs)
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“Piracy” as distinct from traditional compounding
Essentially wholesaling unapproved drugs
 Made from bulk ingredients
 Circumvents FDA drug approval & monitoring process
 Mass markets products with little quality control
 Mimic approved drug (knock-off)
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Omeprazole, enrofloxacin, praziquantal, ivermectin formulations
Beware these are not generics!
Why Piracy?
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Financial Drivers $$$$$
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Pirating firms
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Veterinarians
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Purchase drug at lower price than approved product, pass along or keep
savings
Unfamiliarity
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Mass production with no FDA costs
Lack of appreciation of differences between FDA approved and
compounded drug
Lack knowledge of laws and rules
Mistaking compounded drugs for generic drugs
Assuming provider is working in patient’s best interest
Little enforcement visible in recent history..changing
Approved Drug
Assurances
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Safe
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Effective
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Studied under label conditions of use in target species
No contaminants (chemical, biological, toxins)
Studied under label conditions of use
Not sub- or super-potent (active ingredient)
Formulation proven successful
Batch to batch consistency
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No surprises
You get what you paid for
Approved Drug
Assurances
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Scientifically proven expiration dates
 Scientifically proven withdrawal times
 Proper packaging assures stability
 Label information derived from studies
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Dose, indications, precautions, contraindications
Post-marketing surveillance / Label updates
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Adverse event tracking
Laws & Rules
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Federal Oversight
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Different “rules” for humans vs. animals!
FFDCA does not permit veterinarians to compound
unapproved finished drug products from bulk drug
substances (affirmed by two Federal Appeals Court
decisions)
AMDUCA-permits compounding from approved drugs
FDA Compliance Policy Guide on Compounding
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“when the scope and nature of compounding raise the kinds of
concerns normally associated with a drug manufacturer”
State Oversight
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Board of Pharmacy
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Laws, regulations, policies, standards
Why is Piracy Bad?
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Denies patient treatment with approved drug
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Safe, effective, pure, potent, stable, GMPs
Exposes patient to unapproved drug
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Contaminated, sub- or super-potent, unstable
Exposes parties to unnecessary liability
 Undermines R&D by drug companies
 Veterinarians will have fewer approved drugs
 Bulk ingredients…quality? bio-terrorism?
 Illegal
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AVMA Position on
Compounding
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Decision to use compounded drug driven by
veterinarian within VCPR
 Comply with AMDUCA and FDA Compliance
Policy Guide on Compounding for Animals
 Food safety concerns preclude use unless
information exists to assure avoidance of
illegal tissue residues
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AVMA Position on
Compounding
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Limited to:
Safety and efficacy of compounded drug
demonstrated in target species,
 Response to therapy or drug concentrations can
be monitored, or
 Individual patients where no other drug delivery
is practical.
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Precautions, counsel client, adverse
reactions, unintended exposure
2 Compounding Issues
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Address Piracy
 Compounding from bulk drugs is not legal
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Need regulatory discretion from states and FDA
when veterinarians compound medically
necessary drugs from bulk ingredients for
individual, non-food animals, within a VCPR
because no drug is approved and available to
adequately treat the patient.
New CPG on
Compounding
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Replaced 1996 CPG (federal)
 Emphasizes FDA’s concern with compounding
that approximates manufacturing
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Did it make use of bulk drugs in compounding
illegal?
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Written to facilitate enforcement
No, compounding from bulk drugs has been not
legal for years
However, less text on regulatory discretion..bulk
New CPG on
Compounding
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Less text on regulatory discretion for medically
necessary bulk drugs
 Includes an Appendix
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Bulk drugs for which the FDA would not ordinarily
object if compounded
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Certain large animal antidotes
No listing of bulk drugs that are important
companion animal therapeutics, e.g. potassium bromide
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Makes one worried if needed drug is “not on the list”
Renewed visibility of thorny issue
 Business as usual?
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Should CPG be
withdrawn?
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IACP (pharmacists) lobbying veterinarians
 COBTA says “no”
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Pro-enforcement against mfg. of unapproved drugs
 Seeking ways to specify regulatory discretion
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Medically necessary drugs compounded from bulk
ingredients for individual non-food animals when no such
approved drug exists
COBTA meets March 26-27
In-Office Use
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“In-Office Use” generally recognized by state
Pharmacy Boards
Upon prescription, pharmacist prepares small
quantity for veterinarian’s “in-office” use
(administration)
 Facilitates timely administration of medication since
compounded drug often mailed
 Product labeled “In-Office Use” in place of patient
name
 Stability not definitively known…watch shelf life
 Not to be used as stock from which to dispense
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Makes pharmacist a “wholesaler”
“Resale” of Compounded
Products
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FDA Compliance Policy Guide
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Concern with “compounding drugs for third parties who
resell to individual patients, or offering compounded drugs
at wholesale to other state licensed persons or commercial
entities for resale.”
Possible state Board of Pharmacy rules
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Makes pharmacist a wholesaler
Don’t buy pirated drugs wholesale for resale
 Don’t receive a drug compounded by a
pharmacist for a particular patient, change the
label & dispense
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“Resale” of Compounded
Products
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Question whether you can dispense “In-Office
Use” compounded drug to provide timely
treatment and bridge the time needed for the
mail order drug to arrive (needed regulatory
discretion)
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Question whether you can prescribe, pay for,
and receive a drug compounded by a
pharmacist for a particular patient, then sell it
(unaltered) to the client with a mark-up (?)
Reminders
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A drug is a formulation, not just an active
ingredient
 Changes in formulation affect bioavailability
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Adsorption, Distribution, Metabolism, Excretion
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transdermals
Alterations in bioavailability affect treatment
outcome
Reminders
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Compounded drugs are NOT generics
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Generics have been approved by FDA to ensure
safety, efficacy, quality, stability, package, label
Flavored preparations can be legally
compounded when APPROVED drugs are
flavored
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Flavoring can be an non-legal profit center for
those who flavor bulk drugs without purchaser’s
knowledge
State Compounding Issues
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Arkansas Board of Pharmacy Regulation 0702-0002 Section (m)(5)
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“Compounding for office stock for veterinarians is
prohibited, except for compounds to be used in
life-threatening situations where lack of
immediate availability of the product could result
in patient harm and no FDA-approved product is
commercially available.”
ArVMA opposes, under discussion
State Compounding Issues
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Texas Board of Pharmacy Proposal
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“The quantity of all compounded pharmaceuticals
distributed to all practitioners during the previous 12
months pursuant to this exception does not exceed
5% of all prescriptions compounded and dispensed
during the previous 12 months. For the purposes of
the exception, distributions to practitioners shall not
be included in the 5% if the pharmacy receives and
documents within 30 days of distribution, the name
of the patient to whom the compounded
pharmaceutical was administered.”
“Ethical” Products
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AVMA defines ethical product:
Mfg. voluntarily limits sale to veterinarians
 Often different name/packaging than direct to
consumer products
 Sold only to veterinarians as a condition of sale
that is specified in a sales agreement or on the
product label.
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“Ethical” Products
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AVMA Principles of Vet. Med. Ethics state
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“it is unethical for veterinarians to use or permit
the use of their names, signatures, or
professional status in connection with the resale
of ethical products in a manner which violates
those directions or conditions specified by the
manufacturer to ensure the safe and efficacious
use of the product.”
“Ethical” Product
Diversion
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Distribution channel is manufacturer’s policy
 Not government restricted distribution, e.g. Rx
 Manufacturer’s responsibility to enforce its
policy—contact manufacturer with concerns
 Legally not appropriate for associations to
seek to influence those policies
 Manufacturer may deny future purchases?
 Registered as distributor?
 Tax laws?
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Flea and Tick
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40% of practices only sell flea and tick
products to clients who have visited with the
pet in the last year.
 43% practices sell to anyone
 Source: VetMedTeam.com in Veterinary
Economics, October 2003
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Internet Pharmacies
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Internet pharmacies are here to stay!
Honor client requests for prescriptions
Know your rights
Know your responsibilities
Answers & enforcement frequently found at state level
Do your part right; Can’t police everything
Offer clients value and convenience
Speak factually
Report complaints; Complete documentation
AVMA Position on
Internet Pharmacies
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Drug therapy initiated by DVM within VCPR
 Veterinarians should honor client requests to
prescribe rather than dispense a drug
 Client has option of filling at any pharmacy
 Might advise clients of VIPPS pharmacies
 Veterinarians asked by pharmacies to approve
prescriptions they have not initiated should do
so only if the prescription is appropriate and
VCPR exists
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AVMA Position on
Internet Pharmacies
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Veterinarian’s purview to determine medical
criteria whereby drug is indicated, not
pharmacist
 Maintain written record of prescription
 Communicate proper use, risks regardless of
drug source
 Use of drugs of foreign origin that lack FDA
approval generally is not permitted
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Current Commonly
Asked DVM Questions
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Can I charge for a prescription?
Do I have to provide a prescription?
Can I write a prescription to be used at a Canadian
pharmacy?
Generic substitution?
Can I ignore the fax, but work with client, and offer a
written Rx?
Hospital policy?
What can I say about the pharmacy?
Can I insist the client come in for a written Rx?
Where do I report….?
Other Contacts
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Consumer calls
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Is it legal for my vet to…
Agency Calls: MO, MI, TN, DE responding to
consumers allegations
(Per FTC: It would be within its jurisdiction to create a
regulation if consumer complaints indicate consumers
need greater protection)
Jurisdictional Challenges: agencies may not see total
picture
Internet (human) pharmacy is exploring animal drugs
Environmental ScanningFTC
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1978 FTC regulations require prescribers to provide
eyeglass prescriptions; upheld by courts
Dec. 6, 2003 President Bush signed Fairness to
Contact Lens Consumers Act; FTC jurisdiction
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Congressman’s wife’s experience (10 years), “long
overdue, important consumer’s rights issue”
Requires prescriber to provide copy of prescription
Prescriber may not charge for prescription
Requires prescriber to verify electronic prescription
requests w/in 8 business hours or request is considered
authorized
Consumers Union an early supporter
Environmental Scanning
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Reader’s Digest from Consumer Reports (a
publication of Consumer’s Union)
“…the veterinary care industry languishes in the
Stone Age of consumer-protection law…”
 “…dispute a bill…Fluffy may be held hostage
under state lien laws…”
 “…vets dispense medicine, but few states require
basic price disclosure and some don’t even
mandate written prescriptions for those keen on
bargain hunting…”
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Environmental Scanning
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VIPPS program for “veterinary pharmacies”
 To my knowledge, there are no animal-related:
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Pharmacy school classes required for graduation
 Licensure requirements
 CE requirements
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American College of Veterinary Pharmacists
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Offering certification to pharmacists who complete
educational program on animal drugs and their
regulation
Society of Veterinary Hospital Pharmacists
Revenue Impact of I.P. in
Well-Managed Practices
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Medicine dispensed: 15% total revenue
 50% say volume of meds dispensed declining
 Drop in pharmacy revenue?
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11% drop say 1 percent of respondents
 6-10% drop say 6 percent
 <5% drop say 38 percent
 No change in revenue say 55%
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 Source: The 2003 Well-Managed Practice Study according to
Veterinary Economics, October 2003
Environmental Scanning
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Prepare for change-United Kingdom
Address current medicine margins
 Identify contribution to practice income & profits
 Assess true costs of supplying medicines
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Premises, heating, lighting
 Staff time for ordering, unpacking orders, stock control,
auditing stock and labeling, dispensing.
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Consider difference between all medicine sales
being lost vs.losing half…retain most of cost base
Source: Peter Gripper, Anval, “In Practice”
publication of British Veterinary Assoc.
Environmental Scanning
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Pharmacy and flea and tick products provide an
average of just 3-4% of gross profit and
 Pharmaceuticals have even less of an impact on
the bottom line after accounting for operating
expenses
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Source: Cynthia Wutchiett, Wutchiett, Tumblin and Assoc. in Veterinary
Economics, September 2003
“By overcharging for medications or refusing to
volunteer written prescriptions, the profession
invites both regulation and loss of respect.”
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Source: Linda Walker, Amboy Assoc., Veterinary Economics, Sept 2003
Enviromental Scanning
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“Charge for your time both on the farm and in
the exam room” and
 “Those fighting the Internet are modern day Don
Quixotes.” Source: David M. Lane, DVM Newsmagazine, Jan 2004
 Wake up call: “Change emphasis from selling
products to providing services-and charging
appropriately for services” and
 Sell at competitive prices to avoid client perception
that everything else is overpriced Source: Ronald Whitford,
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Veterinary Forum, Sept 2003
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Impact of pet insurance? Taxation of Internet?
Need for Information
Exchange
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Know your state rules and tell others!
Understand application of jurisdiction
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Groom relationships between Bd. Of Vet Med and Bd of
Pharm
Groom relationships between state VMA and state Boards
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Recycling
Label of dispensed products
Boards know the rules
VMAs have constant interaction with profession
Report trouble! And document! Are laws/rules adequate?
Envision a preferred future