Tags · Access

FDA

United States Food and Drug Administration positions.

39 topics 10 solved Group: Access

Related in this group: insurance · prior authorisation · appeals · formulary · cost per milligram · compounding · shortage · NHS · EMA · MHRA · personal import · telehealth

39 topics · page 1 of 2

Topic	Participants	Replies	Views	Activity
Tracking a shortage from primary sources rather than rumour Access › Shortages shortage FDA formulary Tracking a shortage from primary sources rather than rumour — setting out what I have, and where I think it stops being reliable. Documenting an access outcome, dated, because everything in this category…	+121	126	35k	13h
What a regulator's shortage notice actually authorises Sourcing › Regulatory personal import research use only EMA FDA Solved What a regulator's shortage notice actually authorises — that is the question, and I have not found it answered plainly anywhere I have looked. A logistics question, since the answers here are usually better…	+8	12	15k	17h
How shortages have affected compounding permissions — does this still hold? Access › Shortages compounding shortage formulary FDA Solved How shortages have affected compounding permissions — does this still hold? — that is the question, and I have not found it answered plainly anywhere I have looked. A coverage question with the paperwork…	+27	31	21k	17h
Coming back to: Telehealth prescribing models in the US Regional › North America telehealth FDA compounding insurance Posting this under the heading it deserves: Telehealth prescribing models in the US Everything below is what sits behind that. Documenting an access outcome, dated, because everything in this category…	+26	30	17k	17h
Tracking a shortage from primary sources rather than rumour — the long version Access › Shortages compounding formulary FDA Solved On the subject in the title: Tracking a shortage from primary sources rather than rumour — the long version Working notes rather than a conclusion. Documenting an access outcome, dated, because everything in…		2	60	1d
About the Shortages category Access › Shortages shortage compounding FDA Pinned Wiki Supply interruptions, official shortage notices, and managing an unplanned gap. This post is a community wiki: any member at trust level 3 or above can edit it, and every edit is recorded with its author and…	+3	7	9.9k	1d
How shortages have affected compounding permissions Access › Shortages shortage compounding FDA formulary How shortages have affected compounding permissions I have a specific reason for asking rather than idle curiosity, and the context is below. A coverage question with the paperwork detail included, since that…	+61	71	3.6k	2d
Substitution between formats during a shortage — what changed since Access › Shortages shortage formulary FDA compounding Solved Substitution between formats during a shortage — what changed since — setting out what I have, and where I think it stops being reliable. A coverage question with the paperwork detail included, since that is…	+17	21	2.7k	9d
Prescription requirements and telehealth models — a second dataset Sourcing › Regulatory compounding EMA MHRA personal import On the subject in the title: Prescription requirements and telehealth models — a second dataset Working notes rather than a conclusion. A logistics question, since the answers here are usually better than…	+87	94	1.1k	21d
Labelling requirements for research chemicals — the long version Sourcing › Regulatory MHRA research use only compounding personal import Posting this under the heading it deserves: Labelling requirements for research chemicals — the long version Everything below is what sits behind that. I would like to talk about documentation quality as a…		2	1.8k	2mo
Managing an unplanned gap in supply Access › Shortages shortage formulary FDA compounding Managing an unplanned gap in supply — setting out what I have, and where I think it stops being reliable. A coverage question with the paperwork detail included, since that is what determines the answer.…	+105	110	5.1k	3mo
Why a compound being unapproved is not the same as being illegal to possess Sourcing › Regulatory FDA MHRA research use only EMA Why a compound being unapproved is not the same as being illegal to possess I have a specific reason for asking rather than idle curiosity, and the context is below. Structured report rather than an opinion,…	+72	78	23k	3mo
Follow-up: State-level differences that actually matter Regional › North America FDA telehealth insurance State-level differences that actually matter — setting out what I have, and where I think it stops being reliable. A coverage question with the paperwork detail included, since that is what determines the…	+90	96	4.1k	4mo
About the Regulatory category Sourcing › Regulatory research use only compounding FDA Pinned Wiki Research-use-only status, compounding rules, import restrictions, and the primary documents behind them. This post is a community wiki: any member at trust level 3 or above can edit it, and every edit is…		4	49k	4mo
Labelling requirements for research chemicals Sourcing › Regulatory research use only MHRA FDA Under review Labelling requirements for research chemicals — setting out what I have, and where I think it stops being reliable. Structured report rather than an opinion, following the format the maintainers asked for.…	+5	9	45k	4mo
Research-use-only labelling: what it means and what it does not Sourcing › Regulatory compounding research use only EMA FDA Posting this under the heading it deserves: Research-use-only labelling: what it means and what it does not Everything below is what sits behind that. I would like to talk about documentation quality as a…	+100	110	37k	5mo
Coverage in the US: a map of the usual obstacles Regional › North America FDA insurance telehealth compounding Coverage in the US: a map of the usual obstacles — setting out what I have, and where I think it stops being reliable. A coverage question with the paperwork detail included, since that is what determines the…	+46	50	7.9k	5mo
Prescription requirements and telehealth models Sourcing › Regulatory FDA compounding research use only MHRA Prescription requirements and telehealth models Writing it up because I had to work it out twice and would rather nobody else did. A logistics question, since the answers here are usually better than anywhere…	+91	97	5.4k	7mo
What a regulator's shortage notice actually authorises — what changed since Sourcing › Regulatory research use only EMA FDA compounding Solved The question in the title: What a regulator's shortage notice actually authorises — what changed since I will give what I have already checked below so nobody repeats it. A logistics question, since the…	+22	26	53k	7mo
Substitution between formats during a shortage Access › Shortages compounding FDA formulary shortage Solved Closed On the subject in the title: Substitution between formats during a shortage Working notes rather than a conclusion. Documenting an access outcome, dated, because everything in this category expires. As of…	+114	123	47k	7mo
Managing an unplanned gap in supply — what changed since Access › Shortages compounding FDA formulary On the subject in the title: Managing an unplanned gap in supply — what changed since Working notes rather than a conclusion. A coverage question with the paperwork detail included, since that is what…	+114	124	54k	8mo
Second pass at: Coverage in the US: a map of the usual obstacles Regional › North America insurance telehealth compounding FDA On the subject in the title: Second pass at: Coverage in the US: a map of the usual obstacles Working notes rather than a conclusion. A coverage question with the paperwork detail included, since that is what…		4	62k	9mo
About the North America category Regional › North America FDA compounding insurance Pinned Wiki US and Canadian regulation, compounding, and coverage. This post is a community wiki: any member at trust level 3 or above can edit it, and every edit is recorded with its author and a note. If the scope…	+3	7	43k	9mo
State-level differences that actually matter Regional › North America compounding telehealth insurance FDA Solved On the subject in the title: State-level differences that actually matter Working notes rather than a conclusion. Documenting an access outcome, dated, because everything in this category expires. As of…	+6	10	56k	10mo
[2026 update] US compounding rules and how they changed Regional › North America FDA compounding insurance Solved US compounding rules and how they changed Writing it up because I had to work it out twice and would rather nobody else did. Documenting an access outcome, dated, because everything in this category expires.…	+32	37	7.4k	10mo
Enforcement priorities versus written rules — does this still hold? Sourcing › Regulatory EMA MHRA compounding FDA Solved Under review Enforcement priorities versus written rules — does this still hold? — that is the question, and I have not found it answered plainly anywhere I have looked. Structured report rather than an opinion, following…	+36	40	37k	11mo
Second pass at: Import rules for personal quantities, by jurisdiction, dated Sourcing › Regulatory research use only personal import FDA MHRA Second pass at: Import rules for personal quantities, by jurisdiction, dated Writing it up because I had to work it out twice and would rather nobody else did. A logistics question, since the answers here are…		2	5k	11mo
Revisiting: Why a compound being unapproved is not the same as being illegal to possess Sourcing › Regulatory FDA EMA compounding research use only Closed On the subject in the title: Revisiting: Why a compound being unapproved is not the same as being illegal to possess Working notes rather than a conclusion. Structured report rather than an opinion, following…	+76	82	52k	11mo
Coming back to: Official shortage notices and what they authorise Access › Shortages FDA compounding shortage formulary Official shortage notices and what they authorise Writing it up because I had to work it out twice and would rather nobody else did. A coverage question with the paperwork detail included, since that is what…	+85	92	5.5k	11mo
Canadian access and provincial variation — one year on Regional › North America FDA compounding insurance Canadian access and provincial variation — one year on Writing it up because I had to work it out twice and would rather nobody else did. Documenting an access outcome, dated, because everything in this…	+43	47	964	12mo

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