Showing posts with label legislation. Show all posts
Showing posts with label legislation. Show all posts

Monday, January 29, 2018

California HMDR Laws for 2018

California HMDR Laws for 2018

New CA Home Medical Device Retailer (HMDR) Law - Effective Jan 1, 2018

Read the full Bill:   Bill Text - AB-1387 Home medical device retail facility business: licensing: inspections.:

"AB 1387, Arambula. Home medical device retail facility business: licensing: inspections.

The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.

This bill would modify, until January 1, 2023, the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited, as specified, by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually."

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Source: The legislation above is referenced on the CA HMDR Program website

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Training program and certification for California Home Medical Device Retailers (HMDR) Exemptee license applicants - Earn a completion certificate


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Monday, November 6, 2017

McMorris Rodgers, Loebsack Introduce Bipartisan Legislation to Provide Access to Durable Medical Equipment | Cathy McMorris Rodgers

Updated February 23, 2026

The original link broke.

You can still read about the same topic here:

McMorris Rodgers aims to maintain durable medical device access for rural areas
https://riponadvance.com/stories/health-care/mcmorris-rodgers-aims-maintain-durable-medical-device-access-rural-areas/

---  the original post follows below  ---

Read the full press release:  McMorris Rodgers, Loebsack Introduce Bipartisan Legislation to Provide Access to Durable Medical Equipment | Cathy McMorris Rodgers:

"Eastern Washington Congresswoman Cathy McMorris Rodgers (WA-05) and Congressman Dave Loebsack (IA-02) introduced the bipartisan Protecting Home Oxygen & Medical Equipment (HOME) Access Act of 2017, to preserve access to durable medical equipment (DME), especially in rural communities, by addressing severe cuts to reimbursement rates. Specifically, this legislation delays the July 2016 cuts to DME payments in rural areas, which slashed Medicare reimbursement rates by more than 50 percent on average, and shields payment rates for oxygen concentrators from an outdated regulation that was never intended to apply to rates derived from the Competitive Bidding Program (CBP)."

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Training program for home medical device retailers (HMDR) applying for a California Exemptee license - Earn a training completion certificate



For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

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Saturday, March 19, 2016

New Legislation Will Provide Relief for Rural Home Medical Equipment Suppliers and Their Patients - PR Newswire

Read the full article: New Legislation Will Provide Relief for Rural Home Medical Equipment Suppliers and Their Patients -  PR Newswire:

"Legislation to delay a new round of cuts to rural and non-bid area suppliers and provide additional fixes to the Medicare competitive bidding program for home medical equipment (HME) was introduced late yesterday in the Senate. The lead sponsors for the Patient Access to Durable Medical Equipment Act (S. 2736), are Senators John Thune (R-S.D.) and Heidi Heitkamp (D-N.D.).

This bipartisan, non-controversial, and budget-neutral bill will:" . . .

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California Exemptee License Training Certification

- - -


For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

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Tuesday, February 11, 2014

California's E-Pedigree Law Preempted

Updated September 24, 2020

The link in the original post broke.

Here's the full text article from the California State Board of Pharmacy.  Source:  The Script (Spring 2014, page 4) - California State Board of Pharmacy: E-pedigree Pre-empted by National Tracking System Law .

"On November 27, 2013, President Obama signed Public Law
113-54, which contains provisions for a national tracking system
for prescription medication.

Included within this law are provisions that pre-empt
California’s e-pedigree requirements that were enacted originally
in 2004 and were to be in full effect by July 2017. California’s
Business and Professions Code contains provisions that
effectively preempt California’s provisions if federal legislation
in this area is enacted.

The board is required to post a message about the
inactivation of California’s e-pedigree provisions. This notice
is provided below; it also will be published in the California
Regulatory Notice Register and posted on our website. Also, this
year the board will sponsor legislation to repeal the e-pedigree
provisions that are now inactive provisions in California law.

The board thanks the many individuals including
pharmaceutical supply chain companies, computer and
technology firms, policy makers, staff of the California
delegation and the many others who worked with the board over
the last 10 years to develop e-pedigree provisions and implement
a system to strengthen the integrity of the US drug supply.

We especially thank the early adopters and those who
worked on pilot projects to ensure California’s provisions
would be implemented by the coming deadlines. It was a large
endeavor and we trust that what was learned to “get ready for
California” will be transferable to the national system that is now
under development. We are grateful to have played a role in this
important area of public safety and health.

Public Notice:

Pursuant to Business and Professions Code section 4034.1,
which provides in pertinent part that “[u]pon the effective date
of federal legislation . . . addressing pedigree or serialization
measures for dangerous drugs, Sections 4034, 4163(c)
– (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become
inoperative,” and which requires that within 90 days of the
enactment of such legislation the board publish a notice regarding
the invalidation of these statutes, the California State Board of
Pharmacy is hereby publishing notice that federal legislation
meeting the requirements of section 4034.1 has been enacted, and
that Business and Professions Code sections 4034, 4163, 4163.1,
4163.2, 4163.4, and 4163.5 became inoperative as of November
27, 2013."

- - -  original post follows below  - - -

California Board of Pharmacy - Information on E-Pedigree:

"Public Notice:

Pursuant to Business and Professions Code section 4034.1, which provides in pertinent part that “[u]pon the effective date of federal legislation . . . addressing pedigree or serialization measures for dangerous drugs, Sections 4034, 4163(c) – (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become inoperative,” and which requires that within 90 days of the enactment of such legislation the board publish a notice regarding the invalidation of these statutes, the California State Board of Pharmacy is hereby publishing notice that federal legislation meeting the requirements of section 4034.1 has been enacted, and that Business and Professions Code sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 became inoperative as of November 27, 2013."

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Thursday, November 28, 2013

Obama signs Drug Quality and Security Act into law - SecuringIndustry.com


SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

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Thursday, November 7, 2013

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg:

"One lawmaker’s effort to alter Obamacare is holding up final action by Congress on legislation that would expand U.S. regulation of compounding pharmacies linked to meningitis deaths last year.

The Senate is poised to approve the measure to broaden the U.S. Food and Drug Administration’s oversight of compounding pharmacies. Ninety-nine senators have agreed to pass the legislation that the House passed without a roll call vote, Democratic and Republican lawmakers said.

Republican Senator David Vitter of Louisiana wants the vote on compounding pharmacies coupled with consideration of his proposal to deny lawmakers and their staffs employer contributions when they buy medical insurance on the exchanges set up under the new health-care law. As a result, senators may have to spend a week on work that could be done in minutes."

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Thursday, September 26, 2013

US Senate & House - Drug Quality and Security Act

Updated May 3, 2023

You might also be interested in:

---  the original post follows below  ---

This is promising news, cooperation and agreement between the House and Senate (and across the aisle), to converge on what could likely become final legislation. Stay tuned!

US Senate Committee on Health, Education, Labor, & Pensions: Newsroom - Press Releases:

" “This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards. This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution. I commend the bipartisan spirit that brought this compromise proposal together.” "

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- - -

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Wednesday, September 25, 2013

Survey Finds S.B. 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession


New Poll Finds Senate Bill 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession | Business Wire:

"A recent poll of independent compounding pharmacies by PCCA shows that 4 in 10 of the pharmacies surveyed would be required to abandon the pharmacy profession under the terms of Senate Bill 959, The Pharmaceutical Quality, Security, and Accountability Act."

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Thursday, September 19, 2013

CA To Amend Track-and-Trace Law re: ‘Drop Shipments’

Updated October 2, 2025

The original link broke.

You can still read about the same topic here:
InBrief: California Proposes Breakthrough ePedigree Regulation On Drop Shipments - RxTrace
https://www.rxtrace.com/2013/09/inbrief-california-proposes-breakthrough-epedigree-regulation-on-drop-shipments.html/


---  the original post follows below  ---

California to amend track-and-trace law to deal with ‘drop shipments’:

"The proposal specifies that in the case of a drop shipment, the manufacturer would “omit data elements from the pedigree showing transfers of ownership to and from the wholesale distributor, including any certifications of receipt and delivery of the drug by the wholesaler.”

The electronic pedigree, however, would need to be “conveyed directly from the manufacturer to the authorized purchaser prior to or contemporaneously with the delivery” of the drug, according to the board."

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Monday, September 16, 2013

House Version of Compounding Legislation Emerges, Contrasts With Senate Approach

Updated November 22, 2025

You might also like:

Human Drug Compounding - FDA.gov:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding

---  the original post follows below  ---

House Version of Compounding Legislation Emerges, Contrasting Sharply With Senate Approach:

"Now legislators will be tasked with negotiating out differences in their legislative approaches. The PQSA is significantly more rigorous toward the compounding industry than the Compounding Clarity Act, and also includes track and trace legislative measures. The significant differences and approaches between the two pieces of legislation mean it could be months before any legislation stands a chance of reaching President Barack Obama's desk."

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Saturday, September 14, 2013

The US House Finally Introduces A Compounding Pharmacy Bill | Pharmalot

Updated October 2, 2025

The original link broke.

You might also be interested in:
Compounding and the FDA: Questions and Answers - FDA.gov
https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

---  the original post follows below  ---

The US House Finally Introduces A Compounding Pharmacy Bill | Pharmalot:

"A long-awaited compounding pharmacy bill from the US House of Representatives has finally been introduced and, like a Senate bill introduced earlier this year, offers greater authority to the FDA. But while a key organization representing pharmacists is backing the effort, consumer advocacy groups remain concerned that both bills create loopholes that may create dangers for patients."

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Saturday, August 3, 2013

Senate In Recess - Didn't Vote On Track-and-Trace, Compounding Bill

Updated December 30, 2025

The original link didn't age well.

You might still be interested in:
FDA - Human Drug Compounding:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding

---  the original post follows below  ---

Senate puts off vote for track-and-trace, compounding bill | Drug Store News:

"The Senate was expected to take up a bill designed to secure the drug supply chain and establish a list of "do not compound" medications, but left for recess Friday without voting on it.

The bill, S. 959, the Pharmaceutical Quality, Security and Accountability Act, had received some support from groups like the National Community Pharmacists Association, which supported the bill's goal of enhancing security, but expressed reservations about the compounding provision."

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Sunday, July 14, 2013

Senate Bill S.959 - Text of Pharm Compounding Quality & Accountability Act


Updated October 13, 2021

You might also like:

- - -  original post follows below  - - -

Here's a link to the bill's text as it progresses through Congress.

S.959 - 113th Congress (2013-2014) - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to compounding drugs. - Bill Text | Congress.gov | Library of Congress:

"A BILL - To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding drugs."

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Wednesday, June 19, 2013

Draft Compounding Pharmacy Bill by the House

A nice article with the latest details . . .

FDA Law Blog: Proposed Draft of House Compounding Legislation Released, Comments Wanted by Thursday June 20, 2013:

"This bill does not define a “compounding pharmacy” or create a “compounding manufacturer” category, unlike the pending Senate Health, Education, Labor and Pensions Committee (“HELP”) legislation (S. 959)."

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Saturday, May 25, 2013

Compounding A Crisis At FDA - Forbes Article


Updated October 14, 2025

You might also be interested in:

---  the original post follows below  ---

This is about legislative proceedings happening right now in Washington. Follow the link below to a short commentary.

Compounding A Crisis At FDA - Forbes:

"But all of this doesn’t change the fact that some “compounding” pharmacies are operating as drug makers under the guise of a pharmacy license, breaking existing law, and creating public risks. They are manufacturing drugs with none of the oversight that ensures that their processes are sterile and safe. FDA’s recent inspections of some of these facilities have surfaced widespread, and potentially dangerous biological contaminations of these products. Another tragedy is just a matter of time."

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Tuesday, May 22, 2012

California Board of Pharmacy weighs in on RxTEC proposal

More on potential e-Pedigree touchpoints . . .
, U.S. Congressman.
Henry Waxman, U.S. Congressman.
 (Photo credit: Wikipedia)

SecuringPharma - California Board of Pharmacy weighs in on RxTEC proposal:

"The California Board of Pharmacy in the US has written an open letter to Representative Henry Waxman calling for a federal approach to pharmaceutical traceability that provides the same or greater protection to the public as its electronic pedigree system due to come into effect between 2015 and 2017.

The letter to Waxman - who serves as ranking member of the House Energy and Commerce Committee - also takes a swipe at the Pharmaceutical Traceability Enhancement Code (RxTEC) system enshrined in the Securing Pharmaceutical Distribution Integrity Act of 2012, saying that it is a "less robust, and less secure, supply chain infrastructure.""

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