BILL ANALYSIS �
SENATE JUDICIARY COMMITTEE
Senator Noreen Evans, Chair
2013-2014 Regular Session
SB 506 (Hill)
As Introduced
Hearing Date: April 30, 2013
Fiscal: Yes
Urgency: No
BCP
SUBJECT
Ephedrine: Retail Sale
DESCRIPTION
This bill would require retailers to immediately transmit
information regarding pseudoephedrine purchases to the National
Precursor Log Exchange (NPLEx), a privately funded out-of-state
database. That system would be required to provide retail
distributors with an immediate real-time alert if a person
attempts to purchase pseudoephedrine in violation of the sales
limits. This bill would require the retail distributor to
transmit information regarding the consumer to the database,
including the consumer's name, date of birth, and address and
the product sold, the quantity of packages, and the total gram
amount of pseudoephedrine involved in the sale.
This bill would also repeal existing statutory provisions for
over-the-counter sales of pseudoephedrine and related products
and replace them with new sales limits consistent with federal
law. This bill would impose additional restrictions on the sale
of pseudoephedrine products in accordance with federal law,
including that retail distributors must store those products in
a locked cabinet or behind the counter.
This bill would sunset on January 1, 2019.
BACKGROUND
According to the United States Drug Enforcement Administration,
the number of methamphetamine laboratory (meth lab) incidents
(more)
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dropped in 2012 to 79 (from 107 in 2011 and 182 in 2010). Those
numbers include labs, "dumpsites," or "chemical and glassware"
seizures. Regarding the most common source of meth in the
United States, USA Today's October 11, 2012 article entitled
"Mexican cartels fill demand for meth in USA" reported:
Mexican drug cartels are quietly filling the void in the
nation's drug market created by the long effort to crack
down on American-made methamphetamine, flooding U.S. cities
with exceptionally cheap, extraordinarily potent meth from
factorylike "superlabs."
Although Mexican meth is not new to the U.S. drug trade, it
now accounts for as much as 80 percent of the meth sold
here, according to the Drug Enforcement Administration. And
it is as much as 90 percent pure, a level that offers users
a faster, more intense and longer-lasting high. (Stevenson
and Sherman, USA Today, Mexican cartels fill demand for meth
in USA, Oct. 11, 2012.)
While most meth in the United States appears to be coming from
Mexico, previous concerns were focused on "smurfing." Smurfing
involves purchases of small amounts of pseudoephedrine from
numerous drug stores. That pseudoephedrine is then used to make
methamphetamine. While smurfers may violate federal law in
purchasing more than 9 grams in a month - although each purchase
would not be over the 3.6 gram limit - the lack of adequate law
enforcement personnel and resources to manually review purchase
logs allows smurfing to continue.
In 2006, the federal Combat Methamphetamine Epidemic Act (CMEA)
was enacted to restrict the retail sale of ephedrine,
pseudoephedrine, norpseudoephedrine, or phenylpropanolamine.
States have enacted limits on purchases of pseudoephedrine,
imposed point-of-sale restrictions, or enacted pseudoephedrine
tracking laws. Oregon has required a prescription for
pseudoephedrine purchases since 2006. Mississippi has required
a prescription since July 2010.
Of the states that require electronic tracking (an alternative
to requiring a prescription), at least 24 use the National
Precursor Log Exchange (NPLEx), funded by the manufacturers of
pseudoephedrine products to track pseudoephedrine sales. Those
purchase logs are then freely accessible by law enforcement with
no requirement for a warrant.
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This bill would add California to that list of states by
requiring retail distributors to send purchase information to
NPLEx for purposes of determining whether a proposed sale would
violate limit requirements. Substantially similar to this bill,
AB 1455 (Hill, 2010) was held in this Committee due to privacy
concerns, and AB 1280 (Hill, 2011) was approved by this
Committee with an agreement to work on the privacy issues but
was subsequently held in Senate Appropriations.
This bill was approved by the Senate Committee on Public Safety
on April 9, 2013, by a vote of 7-0.
CHANGES TO EXISTING LAW
Existing law, the California Constitution, provides that all
people have inalienable rights, including the right to pursue
and obtain privacy. (Cal. Const., art. I, Sec. 1.)
Existing law , with specified and detailed exceptions, prohibits
disclosure of medical information without the authorization of
the patient. Medical information shall be disclosed pursuant to
a court order or a warrant issued to a law enforcement agency.
Other specific exceptions are enumerated. (Civ. Code Sec.
56.10.)
Existing law provides that medical information can be disclosed
"when otherwise specifically required by law." (Civ. Code Sec.
56.10 (b)(9).)
Existing federal law includes the Health Insurance Portability
and Accountability Act of 1996 (HIPAA) which, subject to
specified exceptions and procedures, provides that medical
information shall be confidential. (Pub. L. 104-191; 45 C.F.R.
Secs.160, 164.)
Existing law classifies controlled substances in five schedules
according to their dangerousness and potential for abuse.
(Health & Saf. Code Secs. 11054-11058.)
Existing law includes the Controlled Substance Utilization
Review and Evaluation System (CURES) to provide for the
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electronic monitoring of the prescribing and dispensing of
Schedule II, III and IV controlled substances. CURES provides
for the electronic transmission of Schedule II, III and IV
prescription data to the Department of Justice (DOJ) at the time
prescriptions are dispensed. (Health & Saf. Code Sec. 11165.)
Existing law provides that pharmacists, in filling a controlled
substance prescription, shall provide to DOJ the patient's name,
date of birth, the name, form, strength, and quantity of the
drug, and the pharmacy name, pharmacy number, and the
prescribing physician information. (Health & Saf. Code Sec.
11165(d).)
Existing law provides that the DOJ may initiate the referral of
the history of controlled substances dispensed to an individual,
based on the CURES data, to licensed health care practitioners
and pharmacists, as specified. (Health & Saf. Code Sec.
11165.1(b).) Existing law provides that the history of
controlled substances dispensed to a patient based on CURES data
that is received by a practitioner or pharmacist shall be
considered medical information, as specified. (Health & Saf.
Code Sec. 11165.1(c).)
Existing law includes a detailed regulatory scheme for the
production and distribution of specified chemicals that may be
precursors to controlled substances, and provides that producers
and users of precursor chemicals must obtain a permit from DOJ.
Applications for permits must include documentation of
legitimate uses for regulated chemicals. (Health & Saf. Code
Sec. 11106.)
Existing law requires any person or entity that sells,
transfers, or otherwise furnishes a specified chemical
precursor to another person or entity to submit a report to
the DOJ, generally within 21 days, of each transaction. The
report must include the identification information about the
purchaser. (Health & Saf. Code Sec. 11100(d).)
Existing law provides that it is unlawful for a retailer to sell
in a single transaction more than three packages, or 9 grams, of
a product that he or she knows to contain ephedrine,
pseudoephedrine, norpseudoephedrine, or phenylpropanolamine.
With specified exceptions, the three package-9 grams per
transaction limitation applies to any product lawfully furnished
over the counter without a prescription pursuant to applicable
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federal law. This offense is a misdemeanor, punishable by a
county jail term of up to six months, a fine of up to $1,000, or
both. (Health & Saf. Code Sec. 11100 (g)(3).)
Existing federal law, the Combat Methamphetamine Epidemic Act
(CMEA) , includes detailed restrictions and requirements for the
retail sale of ephedrine, pseudoephedrine, norpseudoephedrine,
or phenylpropanolamine. These restrictions include, in part:
no more than 3.6 grams may be sold in a single transaction;
no more than 9 grams per customer may be sold in a one-month
period;
if the drug is obtained through postal or similar delivery, no
more than 7.5 grams can be so obtained;
the seller must maintain a written or electronic logbook of
each sale, including the date of the transaction, the name and
address of the purchaser, and the quantity sold;
the purchaser must present valid identification, as specified,
and the seller must verify the identification;
the purchaser must sign a paper or electronic logbook, as
specified;
the seller must maintain these documents, as specified; and
law enforcement shall have access to the information pursuant
to regulations adopted by the DOJ. (21 U.S.C. Secs. 830(e),
844 (a).)
Existing federal law includes an exception to the log book
recording of transactions in the case of a transaction that
involves a single package that contains not more than 60
milligrams of pseudoephedrine. (21 U.S.C. Sec. 841
(e)(1)(A)(iii).) Existing federal law requires retailers to
retain purchase information for not less than two years. (21
U.S.C. Sec. 841(v)(6).)
Existing federal regulations protect the privacy of individuals
who purchase scheduled listed chemical products by restricting
disclosure of information in logbooks as follows:
the information shall be disclosed as appropriate to the
Administration and to State and local law enforcement
agencies;
the logbook information shall not be accessed, used, or shared
for any purpose other than compliance with CMEA or to
facilitate a product recall; and
a regulated seller who in good faith releases information in a
logbook to Federal, State, or local law enforcement
authorities is immune from civil liability for the release
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unless the release constitutes gross negligence or
intentional, wanton, or willful misconduct. (21 C.F.R. Sec.
1314.45.)
This bill would repeal existing statutory provisions for
over-the-counter sales of pseudoephedrine and replace them with
new purchase limits and electronic tracking of purchases.
This bill would provide that a violation of either the sales
limits or required procedures for a pseudoephedrine transaction
is a misdemeanor, punishable on a first conviction by a fine of
up to $1,000, a jail term of up to six months, or both. Upon a
subsequent conviction, the maximum jail term is one year and the
maximum fine is $10,000.
This bill would include the following procedures and sales
limits:
a retailer must store pseudoephedrine products in a locked
cabinet or behind the counter;
a retailer may sell no more than 3.6 grams of pseudoephedrine
within 24 hours and no more than 9 grams in a 30-day period;
data recording shall not apply to sale of a single package
containing no more than 60 milligrams of a product containing
pseudoephedrine;
the purchaser must present valid government-issued photo
identification;
the retailer must record the following at the time of making a
transaction:
o the date of the transaction;
o the type and number of the buyer's identification,
and the issuing agency;
o the name, date of birth and address of the
purchaser;
o the name and quantity product sold, including gram
weight;
o the name or initials of the person making the sale;
the retailer, as of July 1, 2014, shall immediately transmit
the information about the sale and the purchaser to the
National Precursor Log Exchange (NPLEx) electronic monitoring
system administered by the National Association of Drug
Diversion Investigators (NADDI) for the purpose of determining
whether or not the sale would exceed statutory limits;
the retailer's duty arises when the NPLEx system is available
to retailers without cost;
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the purchaser must provide valid government-issued
identification, as specified; and
the purchaser must sign a written or electronic log.
This bill would, provided that the DOJ executes a memorandum of
understanding (MOU) governing access, require NADDI to forward
California transaction records in NPLEx to the Department of
Justice weekly and provide real-time access to NPLEx information
to law enforcement in the state, as specified. This bill would
state that the MOU shall constitute an enforceable contract, and
additionally require the MOU to:
state that no party to the MOU, nor any entity under contract
to provide the electronic authorization and monitoring system,
shall be authorized to use the information contained in the
system or any purpose other than set forth in this bill, the
federal Combat Methamphetamine Epidemic Act of 2005, or
applicable regulation. The system operator would be
authorized to analyze the information for the sole purpose of
assessing and improving performance and efficacy of the
system; and
require that any retail distributor's access to the database
is limited solely to records of sales transactions made by
that distributor, which shall be solely for the purposes of
complying with federal law or this bill, or to respond to a
duly authorized law enforcement request or court order.
This bill would additionally:
require the system to be capable of providing a retail
distributor with an immediate real-time alert if a sale
violates the legal limits;
state that access by law enforcement to the data contained in
the system from a location other than the retailer shall be
limited to the records of an individual whose attempted
purchase has been denied by the system;
state that neither the DOJ nor any state agency shall bear any
cost for the development, installation, or maintenance of the
system;
require the system's security program to comply with security
standards for the Criminal Justice Information System of the
Federal Bureau of Investigation, and may be audited once a
year by the DOJ;
provide that use of the system by a retail distributor or
vendor of the NPLEx system shall be subject to Civil Code
Section 56.101 (imposing various requirements to preserve the
confidentiality of the medical information); prohibit the
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vendor and those distributors from maintaining any records
collected under the system for no longer than two years, or as
otherwise required by federal law, and state that the records
shall be destroyed pursuant to Civil Code Section
1798.81(requiring disposal by shredding, erasing, or otherwise
modifying the personal information to make it unreadable);
require the system to record law enforcement access to the
system by means of a unique access code for each individual
accessing the system and each user's history shall be
maintained and maybe audited by the DOJ;
allow the DOJ to submit recommendations to NADDI regarding
system changes to assist in identifying false identification
cards; and
state that disputes relating to compliance arising against a
vendor of the NPLEx system shall be subject to a court of
competent jurisdiction, and shall be governed by California
law.
This bill would require the State Board of Equalization to
notify all retailers about the requirement to submit
transactions to NPLEx no later than April 1, 2014.
This bill would not apply to a health care practitioner with
prescriptive authority who is currently licensed in the state.
This bill would state the intent of the Legislature to preempt
all local ordinances or regulations governing the sale by a
retail distributor of over-the-counter products containing
ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine.
This bill would sunset on January 1, 2019.
COMMENT
1. Stated need for the bill
According to the author:
Twenty-six states already mandate the use of real-time
electronic logbooks for [pseudoephedrine (PSE) ] sales:
Alabama, Arizona, Arkansas, Florida, Hawaii, Idaho,
Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,
Michigan, Missouri, Nebraska, North Carolina, North Dakota,
Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia,
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Washington, and West Virginia.
Some propose to limit consumer access to these U.S. Food and
Drug Administration (FDA) approved [over-the-counter] cold
and allergy medications by making them available by
prescription only. They assert that this is the only way to
prevent clandestine methamphetamine production.
While the goal of preventing diversion of the consumer
products is laudable, this prescription-only approach will
only serve to cut off access for millions of California
allergy sufferers, and millions of uninsured Californians.
It will cost the state lost sales tax revenues to the
general fund because OTCs are taxed and prescription
medicines are not. Furthermore, it is not the most
efficient way to prevent criminal activity. The most
efficient mechanism is a uniform, centralized system of
electronic reporting and monitoring of sales.
. . .
Once required by SB 506, access to the electronic tracking
system will be provided at no cost to retailer. The bill
directs retailers to use the National Precursor Log Exchange
(NPLEx) administered by the National Association of Drug
Diversion Investigators (NADDI). NPLEx is paid for by
manufacturers of PSE products to provide real-time
information exchange between all retailers and ensure that
the products are only sold within legal limits.
When a consumer seeks to purchase any OTC PSE-containing
product from a retailer, the retailer will be required to
input the federally-mandated consumer information into the
electronic logbook. Retailers can access the system through
a web-based interface, where the only requirement is a
computer with internet access. . . . The bill provides that
the transaction information shall not be used by retailers
other than for complying with state and federal law, that
purchasers shall be notified that the information is being
collected pursuant to law, and establishes strict privacy
standards for the security of the information.
2. Background on the National Precursor Log Exchange (NPLEx)
This bill seeks to require all retail distributors to use a
database (NPLEx) that will store information regarding every
person who purchases pseudoephedrine-based products within the
State of California without a prescription - that tracking
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system would alert stores when a particular purchaser has
exceeded the specified purchase limit.
For background, the National Association of Drug Diversion
Investigators (NADDI)<1> provides NPLEx at no cost to states.
Funding for the NPLEx database comes from the manufacturers of
pseudoephedrine products, and Appriss (a private company
headquartered in Louisville, Kentucky) provides the software and
houses the service in its data center. The bill would also
allow the Department of Justice (DOJ) to execute a memorandum of
understanding (MOU) with NADDI governing access to the database,
which would also include language seeking to address the privacy
of the information.
That unusual relationship between the State of California and
NADDI raises not only questions about how California may enforce
the provisions of a third party contract (NADDI with Appriss),
but also questions about the database itself. As noted below,
the author has taken several amendments in an attempt to address
these issues.
a. NADDI and Appriss
The proposed requirement for retailers to submit transaction
data to NPLEx appears to be consistent with a multi-state
initiative by the pharmaceutical industry to implement an
electronic tracking of over-the-counter sales of
pseudoephedrine. That initiative is described as follows by
the Consumer Healthcare Products Association (CHPA), a
supporter, in their January 11, 2010 letter to the President
of the Kansas Board of Pharmacy:
On behalf of our member companies that make
nonprescription PSE medicines, CHPA has offered to fully
fund a PSE sales electronic tracking system in Kansas.
CHPA's proposal is the only one that meets the statutory
------------------------
<1> NADDI (est. 1989) is a national non-profit organization
that, according to its Web site, "facilitates cooperation
between law enforcement, healthcare professionals, state
regulatory agencies and pharmaceutical manufacturers in the
investigation and prevention of prescription drug abuse and
diversion. NADDI also sponsors and conducts specialized
educational seminars and conferences." NADDI is based in
Maryland. The association has 21 state chapters, including
California.
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funding requirement, allowing the Board of Pharmacy to
meet its legislative directive.
CHPA's member companies have entered into exclusive
contracts with the nation's leading vendor of PSE
e-tracking systems, and therefore are able only to
provide funding for the system that has been offered to
the Board. We are offering to provide this system, named
the National Precursor Log Exchange (NPLEx), across
multiple states as an integrated solution. . . .
NADDI is a non-profit association that provides education
and training for law enforcement agents on the diversion
of pharmaceutical products. Its role in the NPLEx
initiative is to enter into a Memorandum of Understanding
(MOU) with the appropriate state agency, act as the
administrator of NPLEx, and to liaise with law
enforcement to ensure that NPLEx is understood and fully
utilized.
CHPA's participating member companies are supporting
NPLEx by paying a transactional fee based on sales of
their PSE products. This funding stream fully supports
NPLEx, meaning that the system can be deployed and
maintained at no charge to retailers or to states. Access
to NPLEx is available free of charge to any law
enforcement agent who is properly authorized by the
state. . . .
Reflecting the priority that our member companies have
put on delivering a single vendor platform for NPLEx,
their contracts with Appriss and NADDI are exclusive, and
therefore prohibit our companies from sponsoring systems
operated by any other vendor.
This bill represents the policy choice of joining other states
in selecting a single out-of-state private company to operate
a database that would track purchases of pseudoephedrine
products by requiring retailers to enter the purchaser's
personal information. That database, funded by the
manufacturers of pseudoephedrine products, would log not only
the individual's personal information, but also the product
they purchased.
b. Lack of a direct contract with Appriss, a non-California
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company
Although similar to the process in other states, this bill
would take the unusual approach of requiring retailers to
send sensitive information to NPLEx (an out-of-state
database run by a private company). This bill would allow
the DOJ to enter into a Memorandum of Understanding with
NADDI governing access, and require that MOU to state that
no party to the MOU, nor any entity under contract to
provide the database (Appriss), shall be authorized to use
the information contained in the system for any purpose
other than those set forth in the bill, federal law, or
implementing regulations. The relationship between those
parties raises legal issues of enforcement should Appriss
use (or release) the information in NPLEx for unauthorized
purposes.
For example, if Appriss were to release information to
manufacturers regarding customers who were purchasing
pseudoephedrine based products, including name, address,
type of product, and frequency of purchase, the question
arises as to how that violation could be enforced. The
action would arguably violate the intent of the MOU between
the DOJ and NADDI, but Appriss is arguably not a party to
that agreement. Additionally, since Appriss is located
outside of California, some of California's consumer
protections may not (by default) apply to that release of
information.
In response to this and other concerns about enforceability
of the bill's requirements, SB 506 includes express language
that: (1) the MOU shall constitute an enforceable contract;
and (2) disputes relating to compliance arising against a
vendor of the NPLEx system (Appriss) shall be subject to a
court of competent jurisdiction in California and shall be
governed by California law. Although both of those
provisions increase California's oversight authority over
NADDI (with whom the "enforceable" MOU is with), the actual
entity providing the service is another party, Appriss, who
would not have a direct contractual relationship with DOJ.
c. CURES as an alternative
Committee staff notes that there are alternatives to the
proposed privately held, third-party database.
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Specifically, the CURES program provides for real-time
electronic transmission of specified prescription data to
DOJ. Under CURES, pharmacists, in filling a controlled
substance prescription, must provide to DOJ the patient's
name, date of birth, the name, form, strength, and quantity
of the drug, and the pharmacy name, pharmacy number, and the
prescribing physician information. Essentially the data is
analyzed for indications that controlled substances are
being improperly prescribed, or that drug abusers are
obtaining prescriptions for controlled substances from many
different doctors ("doctor shopping"). Physicians and
pharmacists, in addition to law enforcement, have access to
CURES data through PAR - patient activity reports.
Currently, a private contractor - Infinite Solutions Inc.
(ISI) - collects CURES data for DOJ.
Regarding the viability of using CURES to track
pseudoephedrine sales, the author asserts that CURES
currently lacks the funding to perform its core duties, is
not a real-time system, has limited capacity, and contend
that SB 506 includes more stringent consumer protections
then the existing protections for CURES.
3. Developments since this Committee heard AB 1280 (Hill)
As noted above, this bill is substantially similar to AB 1280
(Hill, 2011), which was approved by this Committee with a
commitment by the author to work on the privacy issues.
Proponents note that this bill, in turn, contains a number of
amendments intended to respond to issues raised in Committee
about AB 1280, including: (1) narrowing the ability for law
enforcement to remotely access information so that only
information about "stopped sales" can be accessed remotely; (2)
providing that the retailer shall not have direct access to
records in the system; (3) providing notice to purchasers, at
the time of sale, that their information is being collected
pursuant to federal law and will be entered into a database; (4)
providing that the retailer and vendor are subject to Civil Code
Section 56.101 (dealing with handling of medical records); (5)
adding the vendor to the prohibition against holding records
longer than two years, as specified; and (6) other provisions,
including the amendments discussed above relating to MOU
enforcement and stating that disputes shall be governed by
California law.
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It should also be noted that since this Committee heard AB 1280,
the United States Government Accountability Office issued a
report entitled: "State Approaches Taken to Control Access to
Key Methamphetamine Ingredient Show Varied Impact on Domestic
Drug Labs," which generally found that electronic tracking
systems help enforce sales limits but have not reduced domestic
methamphetamine (meth) lab incidents. The report further found:
Although electronic tracking can be used to block sales
of more than the legal amount to an individual using a
given identification, through the practice of smurfing,
individuals can undermine this feature and PSE sales limits
by recruiting others to purchase on their behalf or by
fraudulently using another identification to make PSE
purchases.
According to some law enforcement officials, the stop
sale approach of the NPLEx system makes it more challenging
to use the system as an investigative tool than a
lead-generating system because it prevents individuals from
exceeding purchase limits, which would otherwise make them
more readily identifiable to law enforcement as persons of
interest.
The practice by smurfers of using fraudulent
identification to purchase PSE products has been reported
to diminish the ability of electronic tracking systems to
assist in the prosecution of meth related crimes. According
to some law enforcement officials, the rising use of
fraudulent identifications has also increased the need to
gather eyewitness accounts or conduct visual surveillance
to confirm the identities of the individuals, a development
that in turn has been reported to lead to more time - and
resource - intensive investigations. (United States
Government Accountability Office, State Approaches Taken
to Control Access to Key Methamphetamine Ingredient Show
Varied Impact on Domestic Drug Labs (Jan. 2013)
[as of Apr. 26,
2013], p. 29.)
4. Opposition's concerns
The opposition, consisting of consumer groups and narcotics
officers express various concerns about the mandated use of a
privately run database.
a. Database may not reduce meth labs
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Methamphetamine is a highly addictive, destructive drug that
is unique in that it generally cannot be formulated without
relying on a commercially produced compound (pseudoephedrine).
Regarding the number of meth labs in this state, the author
notes that the above-discussed GAO report found "that the
state of California had 444 meth labs in 2006. That number
has dropped in recent years (primarily due to the influx of
Mexican meth) but they remain steady. In 2009 California
discovered 301 meth labs, 206 in 2010, and 122 in 2011."
The California Narcotic Officers' Association (CNOA), in
opposition, notes that their organization is on the front
lines of the battle against methamphetamine trafficking and
asserts that "[e]xperience in other states has taught us that
the strategy contemplated by [SB] 506 - computer tracking of
sales - will not achieve the objective of reducing meth labs.
It is instructive to note that the state of Kentucky, which is
characterized by the industry as the 'Gold Standard' for this
methodology, has been a [] failure in the reduction of meth
labs. In fact, since enactment of computer tracking in the
Blue Grass State, Kentucky achieved the dubious distinction of
having more meth labs then at any other time in the state's
history." CNOA further asserts that "[a]s an alternative to a
prescription approach, CNOA believes there is merit to a
legislative approach that simply requires all pseudo-ephedrine
sold in California to contain the requisite binder agents that
prevent-or seriously impair-their conversion to
methamphetamine."
Supporters, in response, note the large number of sales that
have been stopped nationwide as a result of the NPLEx system.
Staff notes that although there have been stopped sales, it is
unclear what percentage of those sales would have gone towards
making methamphetamine as opposed to inadvertent attempts to
purchase more than the legal limit.
b. Law enforcement access
This bill would allow law enforcement to access information
submitted by retailers, require that access to be recorded by
means of a unique access code, and require each law
enforcement user's history to be maintained and provide that
the DOJ may audit that history. While the bill would allow
DOJ to enter into an MOU with NADDI governing access, NADDI
would be required to "provide real-time access to NPLEx
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information through the NPLEx online portal to law enforcement
in the state as authorized by the department." Although this
bill does not restrict law enforcement in other states from
accessing that customer information, the information which can
be accessed remotely would be limited to records of an
individual whose attempted purchase has been denied by the
system (a stopped sale).
The American Civil Liberties Union (ACLU), in an oppose unless
amended position, argues that SB 506 "would permit access to
an individual's or many individuals' information from a retail
distributor. Law enforcement officers could follow up with
individuals after their purchase of a packet of the common
congestion remedy, 'Sudafed,' and grill them about why they
purchased it, what their medical condition is, and other
private information. These absurd results should be avoided."
Regarding the sales stopped as a result of the proposed
database (those denials are arguably more likely to happen due
to an innocent mistake as opposed to a smurfer who is well
acquainted with pseudoephedrine restrictions), the bill states
that the "Legislature finds that it is necessary for probable
cause to be demonstrated to trigger an investigation in
connection with an individual whose requested purchase is
denied by the system a single time." That provision codifies
an important point - just because an individual is denied a
single purchase does not mean that the single denial, absent
probable cause, should be sufficient to trigger an
investigation. If that were the circumstance, many
individuals, who accidentally attempt to purchase an amount
over the statutory limit, could find themselves the subject of
an investigation.
The ACLU further notes that "[l]aw enforcement access to
prescription medication requires that law enforcement obtain a
search warrant under the California Confidentiality of Medical
Information Act," and asserts that, if this bill is to move
forward, it is imperative to include a similar warrant
requirement. The author, in response, contends:
Information regarding the purchase of OTC medications
should not be treated the same way prescription
medications are under the Confidentiality of Medical
Information Act (CMIA). The CMIA is intended to protect
the relationship between the health care provider and the
SB 506 (Hill)
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patient, which exists when a prescription is written. No
such relationship exists when an individual purchases a
medication available over the counter, and seldom are OTC
products purchased in consultation with a medical
professional other than a pharmacist. When OTC products
are purchased, there is no record of physician/patient
discussions or other communications that involve medical
information.
5. Remaining privacy concerns raised by the opposition
Privacy Rights Clearinghouse, in an oppose unless amended
position, states that while the bill is well-intended, the bill
would sacrifice the privacy of innocent consumers in the hope of
locating "leads" to supposed criminal activity. Privacy Rights
Clearinghouse and the ACLU states that they must oppose SB 506
unless it incorporates the above warrant requirement and the
following privacy protections:
clear and conspicuous notice before an individual
purchases these products, explaining that the information
gathered will be added to a database;
the database should be held by DOJ rather than by a
private company;
the legislation incorporates at a minimum the following
security and privacy protections: (1) the security breach
laws should apply; (2) a private right of action by the
purchser if data is used, disclosed, or shared in violation
of the law; (3) an annual independent audit (and public
report) of the use of the system by the DOJ; and (4)
destruction of a purchaser's personal information in the
database at the time of expiration of the statute of
limitations for prosecution of a purchaser; and
an electronic audit trail of all access to the database,
which should be subject to DOJ oversight.
The author, in response, contends that security breach laws do
apply, a private right of action is incorporated by reference to
Civil Code Section 56.101, that DOJ is allowed to audit the
system once per year, and notes that personal information is
currently required to be destroyed after two years or as
otherwise required by federal law.
Support : BIOCOM; California Chamber of Commerce; California
District Attorneys Association; California Healthcare Institute;
SB 506 (Hill)
PageR of?
California Manufacturers & Technology Association; California
Pharmacists Association; California Retailers Association;
California State Sheriffs'Association; Dean F. Growdon, Sheriff
of Lassen County; E.G. Prieto, Sheriff of Yolo County; Healthy
African American Families, Phase II; Johnson & Johnson; National
Association of Chain Drug Stores; Peace Officers Research
Association of California; Reckitt Benckiser; Rite Aid;
Sacramento Metro Chamber; Sanofi, US; Tom Bosenko, Sheriff of
Shasta County; Valley Industry & Commerce Association
Opposition : American Civil Liberties Union (unless amended);
California Narcotic Officers' Association; Electronic Frontier
Foundation; Privacy Rights Clearinghouse (unless amended)
HISTORY
Source : Consumer Healthcare Products Association (CHPA)
Related Pending Legislation : None Known
Prior Legislation :
AB 1455 (Hill, 2010) See Background.
AB 1280 (Hill, 2011) See Background.
Prior Vote : Senate Committee on Public Safety (Ayes 7, Noes 0)
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